Covid-19 roundup: CureVac beefs up its unicorn IPO dreams as billionaire owner takes this Covid-19 mRNA player on a forced march to Nasdaq; Kodak’s…

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotechs future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago bidding Merck vet Roger Pomerantz farewell from the C suite and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Covid-19 roundup: CureVac beefs up its unicorn IPO dreams as billionaire owner takes this Covid-19 mRNA player on a forced march to Nasdaq; Kodak's...

Nearly 70K donated so far towards Wistaston boy’s 120K lifesaving treatment – Cheshire Live

A WIstaston family are overwhelmed by the generosity of people who have donated nearly 70K so far towards the 120K needed for lifesaving treatment for their 11-year-old son.

Georgy Capener was diagnosed with the highly malignant Ewings Sarcoma, a rare form of bone cancer, following a fall in a friends's garden on Easter Sunday in 2018.

He has undergone numerous rounds of high dose aggressive chemotherapy and radiotherapy since then, lost his right arm as a result of the treatment and now has a titanium prosthesis.

Georgy went into remission last March, but the cancer returned in April this year, this time in his left sinus, just under his eye socket and in the back of his nose.

The Wistaston Church Lane pupil is now undergoing chemotherapy and radiotherapy again - but the vital stem cell therapy which is essential to ensure he can live a normal, healthy life and prevent the cancer returning at a later stage costs 130,000 and is not available for Georgy on the NHS.

The money needs to be raised by the beginning of September, when Georgy is due to finish his final round of chemotherapy, as, for the stem cell treatment to be successful, the procedure would have to start immediately after that to ensure the cancer doesnt return straight away,

This week Georgys mum, Helen Capener, was close to tears she was so overwhelmed by the generosity of people who have donated and organised fundraisers.

I just cant believe the total raised so far, she said. Its just so nice. Weve got fundraisers doing things all over the place, my cousins biking from Peterborough to Crewe, weve got people in Cheadle doing stuff, everywhere, its brilliant

Ive been trying to keep up with whos donating. Its so lovely, Im still overwhelmed.

She said money had flooded in from Crewe Chronicle, CheshireLive and Liverpool Echo readers.

Passionate Liverpool fan Georgy has also received a video message of support from the Reds defender Andy Robertson.

It was brilliant, said Helen. Unfortunately I wasnt there when he received it. It was his dads turn to take him to radiotherapy so he saw it in the car so I didnt see his reaction but his dad said he was absolutely over the moon. His little face lit up and he just loves it. As soon as he came back, he ran in to show me.

There are so many fundraising events taking place to raise money for Georgys treatment, it is impossible to list them all here.

They range from an online fitness class which took place on Saturday, to people walking up Snowdon at the end of this month, one person has sold off their vinyl collection, others are making T-shirts and hoodies with the Georgys Fight logo, theres a big raffle and Georgys Fight jewellery being made and sold by another fundraiser.

A Facebook Page set up by a family friend, called Georgys Fight, lists how you can help.

Helen said that she and husband, Richard, cant thank people enough.

Georgy is undergoing his last round of chemotherapy this week.

Speaking earlier this week, Helen said: He finishes his radiotherapy this Friday (August 7) so hes struggling a bit now. Hes been having lots of nosebleeds and hes got an ulcer right at the back of his throat so hes still unable to eat much and hes got ulcers all on the left hand side of his cheek which are stinging.

They did tell us that this would happen and we expected it a bit earlier, so hes done really well to get this far but the last week or so started to take its toll.

Hes got four more sessions after this and its finished.

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He didnt want to go this morning because he knows that at each session its going to hurt even more, but he always bounces back. Once hes finished the radiotherapy, give him a couple of weeks and hell be back to feeling ok again I think.

Georgy has been accepted by a clinic in Thailand to undergo the vital stem cell treatment he needs next month but it is essential the treatment starts in September ensure the cancer doesnt return straight away,

That is why the family set up the JustGiving fundraising page to help save our sons life.

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Nearly 70K donated so far towards Wistaston boy's 120K lifesaving treatment - Cheshire Live

Coronavirus Drug and Treatment Tracker – The New York Times

The Covid-19 pandemic is one of the greatest challenges modern medicine has ever faced. Doctors and scientists are scrambling to find treatments and drugs that can save the lives of infected people and perhaps even prevent them from getting sick in the first place.

Below is an updated list of 20 of the most-talked-about treatments for the coronavirus. While some are accumulating evidence that theyre effective, most are still at early stages of research. We also included a warning about a few that are just bunk.

We are following 20 coronavirus treatments for effectiveness and safety:

Tentative or

mixed evidence

We are following 20 coronavirus treatments

for effectiveness and safety:

Tentative or

mixed evidence

We are following 20 coronavirus treatments

for effectiveness and safety:

There is no cure yet for Covid-19. And even the most promising treatments to date only help certain groups of patients and await validation from further trials. The F.D.A. has not fully licensed any treatment specifically for the coronavirus. Although it has granted emergency use authorization to some treatments, their effectiveness against Covid-19 has yet to be demonstrated in large-scale, randomized clinical trials.

This list provides a snapshot of the latest research on the coronavirus, but does not constitute medical endorsements. Always consult your doctor about treatments for Covid-19.

New additions and recent updates:

Added ivermectin, a drug typically used against parasitic worms that is being increasingly prescribed in Latin America. Aug. 10

Updated descriptions for several treatments. Aug. 10

We will update and expand the list as new evidence emerges. For details on evaluating treatments, see the N.I.H. Covid-19 Treatment Guidelines. For the current status of vaccine development, see our Coronavirus Vaccine Tracker.

WIDELY USED: These treatments have been used widely by doctors and nurses to treat patients hospitalized for diseases that affect the respiratory system, including Covid-19.

PROMISING EVIDENCE: Early evidence from studies on patients suggests effectiveness, but more research is needed. This category includes treatments that have shown improvements in morbidity, mortality and recovery in at least one randomized controlled trial, in which some people get a treatment and others get a placebo.

TENTATIVE OR MIXED EVIDENCE: Some treatments show promising results in cells or animals, which need to be confirmed in people. Others have yielded encouraging results in retrospective studies in humans, which look at existing datasets rather than starting a new trial. Some treatments have produced different results in different experiments, raising the need for larger, more rigorously designed studies to clear up the confusion.

NOT PROMISING: Early evidence suggests that these treatments do not work.

PSEUDOSCIENCE OR FRAUD: These are not treatments that researchers have ever considered using for Covid-19. Experts have warned against trying them, because they do not help against the disease and can instead be dangerous. Some people have even been arrested for their false promises of a Covid-19 cure.

EVIDENCE IN CELLS, ANIMALS or HUMANS: These labels indicate where the evidence for a treatment comes from. Researchers often start out with experiments on cells and then move onto animals. Many of those animal experiments often fail; if they dont, researchers may consider moving on to research on humans, such as retrospective studies or randomized clinical trials. In some cases, scientists are testing out treatments that were developed for other diseases, allowing them to move directly to human trials for Covid-19.

All treatmentsWidely usedPromisingTentative or mixedNot promisingPseudoscience

Antivirals can stop viruses such as H.I.V. and hepatitis C from hijacking our cells. Scientists are searching for antivirals that work against the new coronavirus.

PROMISING EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSEMERGENCY USE AUTHORIZATIONRemdesivirRemdesivir, made by Gilead Sciences, was the first drug to get emergency authorization from the F.D.A. for use on Covid-19. It stops viruses from replicating by inserting itself into new viral genes. Remdesivir was originally tested as an antiviral against Ebola and Hepatitis C, only to deliver lackluster results. But preliminary data from trials that began this spring suggested the drug can reduce the recovery time of people hospitalized with Covid-19 from 15 to 11 days. (The study defined recovery as either discharge from the hospital or hospitalization for infection-control purposes only.) These early results did not show any effect on mortality, though retrospective data released in July hints that the drug might reduce death rates among those who are very ill.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSFavipiravirOriginally designed to beat back influenza, favipiravir blocks a viruss ability to copy its genetic material. A small study in March indicated the drug might help purge the coronavirus from the airway, but results from larger, well-designed clinical trials are still pending.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSMK-4482Another antiviral originally designed to fight the flu, MK-4482 (previously known as EIDD-2801) has had promising results against the new coronavirus in studies in cells and on animals. Merck, which has been running clinical trials on the drug this summer, has announced it will launch a large Phase III trial in September.Updated Aug. 6

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS Recombinant ACE-2To enter cells, the coronavirus must first unlock them a feat it accomplishes by latching onto a human protein called ACE-2. Scientists have created artificial ACE-2 proteins which might be able to act as decoys, luring the coronavirus away from vulnerable cells. Recombinant ACE-2 proteins have shown promising results in experiments on cells, but not yet in animals or people.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS AND HUMANS IvermectinFor decades, ivermectin has served as a potent drug to treat parasitic worms. Doctors use it against river blindness and other diseases, while veterinarians give dogs a different formulation to cure heartworm. Studies on cells have suggested ivermectin might also kill viruses. But scientists have yet to find evidence in animal studies or human trials that it can treat viral diseases. As a result, Ivermectin is not approved to use as an antiviral.

In April, Australian researchers reported that the drug blocked coronaviruses in cell cultures, but they used a dosage that was so high it might have dangerous side effects in people. The FDA immediately issued a warning against taking pet medications to treat or prevent Covid-19. These animal drugs can cause serious harm in people, the agency warned.

Since then a number of clinical trials have been launched to see if a safe dose of ivermectin can fight Covid-19. In Singapore, for example, the National University Hospital is running a 5,000-person trial to see if it can prevent people from getting infected. As of now, theres no firm evidence that it works. Nevertheless ivermectin is being prescribed increasingly often in Latin America, much to the distress of disease experts.Updated Aug. 10

NOT PROMISING EVIDENCE IN CELLS AND HUMANS Lopinavir and ritonavirTwenty years ago, the F.D.A. approved this combination of drugs to treat H.I.V. Recently, researchers tried them out on the new coronavirus and found that they stopped the virus from replicating. But clinical trials in patients proved disappointing. In early July, the World Health Organization suspended trials on patients hospitalized for Covid-19. They didnt rule out studies to see if the drugs could help patients not sick enough to be hospitalized, or to prevent people exposed to the new coronavirus from falling ill. The drug could also still have a role to play in certain combination treatments.

NOT PROMISING EVIDENCE IN CELLS, ANIMALS AND HUMANSHydroxychloroquine and chloroquineGerman chemists synthesized chloroquine in the 1930s as a drug against malaria. A less toxic version, called hydroxychloroquine, was invented in 1946, and later was approved for other diseases such as lupus and rheumatoid arthritis. At the start of the Covid-19 pandemic, researchers discovered that both drugs could stop the coronavirus from replicating in cells.

Since then, theyve had a tumultuous ride. A few small studies on patients offered some hope that hydroxychloroquine could treat Covid-19. The World Health Organization launched a randomized clinical trial in March to see if it was indeed safe and effective for Covid-19, as did Novartis and a number of universities. Meanwhile, President Trump repeatedly promoted hydroxychloroquine at press conferences, touting it as a game changer, and even took it himself. The F.D.A. temporarily granted hydroxychloroquine emergency authorization for use in Covid-19 patients which a whistleblower later claimed was the result of political pressure. In the wake of the drugs newfound publicity, demand spiked, resulting in shortages for people who rely on hydroxychloroquine as a treatment for other diseases.

But more detailed studies proved disappointing. A study on monkeys found that hydroxychloroquine didnt prevent the animals from getting infected and didnt clear the virus once they got sick. Randomized clinical trials found that hydroxychloroquine didnt help people with Covid-19 get better or prevent healthy people from contracting the coronavirus. Another randomized clinical trial found that giving hydroxychloroquine to people right after being diagnosed with Covid-19 didnt reduce the severity of their disease. (One large-scale study that concluded the drug was harmful as well was later retracted.) The World Health Organization, the National Institutes of Health and Novartis have since halted trials investigating hydroxychloroquine as a treatment for Covid-19, and the F.D.A. revoked its emergency approval. The F.D.A. now warns that the drug can cause a host of serious side effects to the heart and other organs when used to treat Covid-19.

In July, researchers at Henry Ford hospital in Detroit published a study finding that hydroxychloroquine was associated with a reduction in mortality in Covid-19 patients. President Trump praised the study on Twitter, but experts raised doubts about it. The study was not a randomized controlled trial, in which some people got a placebo instead of hydroxychloroquine. The studys results might not be due to the drug killing the virus. Instead, doctors may have given the drug to people who were less sick, and thus more likely to recover anyway.

Despite negative results, a number of hydroxychloroquine trials have continued, although most are small, testing a few dozen or a few hundred patients. A recent analysis by STAT and Applied XL found more than 180 ongoing clinical trials testing hydroxychloroquine or chloroquine, for treating or preventing Covid-19. Although its clear the drugs are no panacea, its theoretically possible they could provide some benefit in combination with other treatments, or when given in early stages of the disease. Only well-designed trials can determine if thats the case.Updated Aug. 10

Most people who get Covid-19 successfully fight off the virus with a strong immune response. Drugs might help people who cant mount an adequate defense.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS AND HUMANS Convalescent plasmaA century ago, doctors filtered plasma from the blood of recovered flu patients. So-called convalescent plasma, rich with antibodies, helped people sick with flu fight their illness. Now researchers are trying out this strategy on Covid-19. In May, the F.D.A. designated convalescent plasma an investigational product. That means that despite not yet being shown as safe and effective, plasma can be used in clinical trials and given to some patients who are seriously ill with Covid-19. Tens of thousands of patients in the U.S. have received plasma through a program launched by the Mayo Clinic and the federal government.

The Trump administration has praised convalescent plasma, despite the lack of evidence yet that it works. The first wave of trials have been small and the results have been mixed. Large randomized clinical trials are underway, but theyve struggled to enroll enough participants, some of whom worry they will receive a placebo instead of the treatment itself.

Experts say that its vital to complete these trials to determine if convalescent plasma is safe and effective. If these trials are successful, it could serve as an important stopgap measure until more potent therapies become widely available.Updated Aug. 10

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSMonoclonal antibodiesConvalescent plasma from people who recover from Covid-19 contains a mix of different antibodies. Some of the molecules can attack the coronavirus, but many are directed at other pathogens. Researchers have sifted through this slurry to find the most potent antibodies against Covid-19. They have then manufactured synthetic copies of these molecules, known as monoclonal antibodies. Researchers have begun investigating them as a treatment for Covid-19, either individually or in cocktails.

Monoclonal antibodies were first developed as a therapy in the 1970s, and since then the F.D.A. has approved them for 79 diseases, ranging from cancer to AIDS. Since the start of the pandemic, researchers have found dozens of monoclonal antibodies that show promise against Covid-19 in preclinical studies on cells and animals. Companies like Eli Lilly and Regeneron recently began clinical trials studying monoclonal antibodies. Several other firms, as well as teams at universities, are slated to enter the race soon as well.Updated Aug. 10

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSInterferonsInterferons are molecules our cells naturally produce in response to viruses. They have profound effects on the immune system, rousing it to attack the invaders, while also reining it in to avoid damaging the bodys own tissues. Injecting synthetic interferons is now a standard treatment for a number of immune disorders. Rebif, for example, is prescribed for multiple sclerosis.

As part of its strategy to attack our bodies, the coronavirus appears to tamp down interferon. That finding has encouraged researchers to see whether a boost of interferon might help people weather Covid-19, particularly early in infection. Early studies, including experiments in cells and mice, have yielded encouraging results that have led to clinical trials.

An open-label study in China suggested that the molecules could help prevent healthy people from getting infected. On July 20, the British pharmaceutical company Synairgen announced that an inhaled form of interferon called SNG001 lowered the risk of severe Covid-19 in infected patients in a small clinical trial. The full data have not yet been released to the public, or published in a scientific journal. On August 6, the National Institute of Allergy and Infectious Diseases launched a Phase III trial on a combination of Rebif and the antiviral remdesivir, with results expected by fall 2020.Updated Aug. 10

The most severe symptoms of Covid-19 are the result of the immune systems overreaction to the virus. Scientists are testing drugs that can rein in its attack.

PROMISING EVIDENCE EVIDENCE IN HUMANS DexamethasoneThis cheap and widely available steroid blunts many types of immune responses. Doctors have long used it to treat allergies, asthma and inflammation. In June, it became the first drug shown to reduce Covid-19 deaths. That study of more than 6,000 people, which in July was published in the New England Journal of Medicine, found that dexamethasone reduced deaths by one-third in patients on ventilators, and by one-fifth in patients on oxygen. It may be less likely to help and may even harm patients who are at an earlier stage of Covid-19 infections, however. In its Covid-19 treatment guidelines, the National Institutes of Health recommends only using dexamethasone in patients with COVID-19 who are on a ventilator or are receiving supplemental oxygen.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN HUMANS Cytokine InhibitorsThe body produces signaling molecules called cytokines to fight off diseases. But manufactured in excess, cytokines can trigger the immune system to wildly overreact to infections, in a process sometimes called a cytokine storm. Researchers have created a number of drugs to halt cytokine storms, and they have proven effective against arthritis and other inflammatory disorders. Some turn off the supply of molecules that launch the production of the cytokines themselves. Others block the receptors on immune cells to which cytokines would normally bind. A few block the cellular messages they send. Depending on how the drugs are formulated, they can block one cytokine at a time, or muffle signals from several at once.

Against the coronavirus, several of these drugs have offered modest help in some trials, but faltered in others. Drug companies Regeneron and Roche drug both recently announced that two drugs called sarilumab and tocilizumab, which both target the cytokine IL-6, did not appear to benefit patients in Phase 3 clinical trials. Many other trials remain underway, several of which combine cytokine inhibitors with other treatments.Updated Aug. 10

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN HUMANS EMERGENCY USE AUTHORIZATIONBlood filtration systemsThe F.D.A. has granted emergency use authorization to several devices that filter cytokines from the blood in an attempt to cool cytokine storms. One machine, called Cytosorb, can reportedly purify a patients entire blood supply about 70 times in a 24-hour period. A small study in March suggested that Cytosorb had helped dozens of severely ill Covid-19 patients in Europe and China, but it was not a randomized clinical trial that could conclusively demonstrate it was effective. A number of studies on blood filtration systems are underway, but experts caution that these devices carry some risks. For example, such filters could remove beneficial components of blood as well, such as vitamins or medications.Updated Aug. 10

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN HUMANS Stem cellsCertain kinds of stem cells can secrete anti-inflammatory molecules. Over the years, researchers have tried to use them as a treatment for cytokine storms, and now dozens of clinical trials are under way to see if they can help patients with Covid-19. But these stem cell treatments havent worked well in the past, and its not clear yet if theyll work against the coronavirus.

Doctors and nurses often administer other supportive treatments to help patients with Covid-19.

WIDELY USEDProne positioningThe simple act of flipping Covid-19 patients onto their bellies opens up the lungs. The maneuver has become commonplace in hospitals around the world since the start of the pandemic. It might help some individuals avoid the need for ventilators entirely. The treatments benefits continue to be tested in a range of clinical trials.

WIDELY USEDEMERGENCY USE AUTHORIZATIONVentilators and other respiratory support devicesDevices that help people breathe are an essential tool in the fight against deadly respiratory illnesses. Some patients do well if they get an extra supply of oxygen through the nose or via a mask connected to an oxygen machine. Patients in severe respiratory distress may need to have a ventilator breathe for them until their lungs heal. Doctors are divided about how long to treat patients with noninvasive oxygen before deciding whether or not they need a ventilator. Not all Covid-19 patients who go on ventilators survive, but the devices are thought to be lifesaving in many cases.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN HUMANS AnticoagulantsThe coronavirus can invade cells in the lining of blood vessels, leading to tiny clots that can cause strokes and other serious harm. Anticoagulants are commonly used for other conditions, such as heart disease, to slow the formation of clots, and doctors sometimes use them on patients with Covid-19 who have clots. Many clinical trials teasing out this relationship are now underway. Some of these trials are looking at whether giving anticoagulants before any sign of clotting is beneficial.

False claims about Covid-19 cures abound. The F.D.A. maintains a list of more than 80 fraudulent Covid-19 products, and the W.H.O. debunks many myths about the disease.

WARNING: DO NOT DO THISDrinking or injecting bleach and disinfectantsIn April, President Trump suggested that disinfectants such as alcohol or bleach might be effective against the coronavirus if directly injected into the body. His comments were immediately refuted by health professionals and researchers around the world as well as the makers of Lysol and Clorox. Ingesting disinfectant would not only be ineffective against the virus, but also hazardous possibly even deadly. In July, Federal prosecutors charged four Florida men with marketing bleach as a cure for COVID-19.

WARNING: NO EVIDENCEUV lightPresident Trump also speculated about hitting the body with ultraviolet or just very powerful light. Researchers have used UV light to sterilize surfaces, including killing viruses, in carefully managed laboratories. But UV light would not be able to purge the virus from within a sick persons body. This kind of radiation can also damage the skin. Most skin cancers are a result of exposure to the UV rays naturally present in sunlight.

WARNING: NO EVIDENCESilverThe F.D.A. has threatened legal action against a host of people claiming silver-based products are safe and effective against Covid-19 including televangelist Jim Bakker and InfoWars host Alex Jones. Several metals do have natural antimicrobial properties. But products made from them have not been shown to prevent or treat the coronavirus.

Note: After additional discussions with experts we have adjusted several labels on the tracker. The Strong evidence label has been removed until further research identifies treatments that consistently benefit groups of patients infected by the coronavirus. In its place, Promising evidence will be used for drugs such as remdesivir and dexamethasone that have shown promise in at least one randomized controlled trial, and Widely used for treatments such as proning and ventilators that are often used with severely ill patients, including those with Covid-19. And we may reintroduce the Ineffective label when ongoing clinical trials repeatedly end with disappointing results.

Sources: National Library of Medicine; National Institutes of Health; William Amarquaye, University of South Florida; Paul Bieniasz, Rockefeller University; Jeremy Faust, Brigham & Womens Hospital; Matt Frieman, University of Maryland School of Medicine; Noah Haber, Stanford University; Swapnil Hiremath, University of Ottawa; Akiko Iwaskai, Yale University; Paul Knoepfler, University of California, Davis; Elena Massarotti, Brigham and Womens Hospital; John Moore and Douglas Nixon, Weill Cornell Medical College; Erica Ollman Saphire, La Jolla Institute for Immunology; Regina Rabinovich, Harvard T.H. Chan School of Public Health; Ilan Schwartz, University of Alberta; Phyllis Tien, University of California, San Francisco.

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Coronavirus Drug and Treatment Tracker - The New York Times

Avacta extends partnership with Daewoong Pharmaceutical and AffyXell Therapeutics for Covid-19 stem cell treatments – Cambridge Independent

Avacta has extended its collaboration and license agreement with Daewoong Pharmaceutical Co and their South Korean joint venture AffyXell Therapeutics.

They will develop stem cell treatments incorporating Avactas neutralising Affimer therapy for the treatment of seriously ill patients with Covid-19 and prepare for the rapid development of similar therapies for future global pandemics.

Stem cell therapies offer one potential route to repairing lung tissue damage caused by the immune systems over-reaction to respiratory diseases such as Covid-19.

AffyXell Therapeutics, a next-generation cell and gene therapy joint venture between Whittlesford-based Avacta and Daewoong, is developing mesenchymal stem cell (MSC) treatments engineered to produce Affimer therapies in the patient at the site of action.

The partnership has been extended to include Affimer molecules that target viruses, such as coronaviruses, to develop therapies that repair lung damage, while also producing neutralising Affimer molecules to prevent the progression of the disease.

Under the expanded partnership, AffyXell will engineer mesenchymal stem cells to express SARS-CoV-2 neutralising Affimer molecules to develop treatments for seriously ill Covid-19 patients. It will also prepare for rapid development of next-generation stem cell therapies for future infectious respiratory disease outbreaks.

Avacta CEO Dr Alastair Smith said: I am very pleased to have extended our collaboration and license agreement with Daewoong Pharmaceutical to include the SARS-CoV-2 neutralising Affimer molecules for the treatment of Covid-19 and to create the potential to respond very rapidly in future to global virus threats.

AffyXell will address the need over the coming years for advanced stem cell therapies to treat lung damage caused by cytokine release syndrome suffered by Covid-19 patients and, at the same time, help prevent disease progression in these patients through the action of a neutralising Affimer therapy.

More broadly, one of the key areas of unmet clinical need that AffyXell can address with its next-generation mesenchymal stem cell therapies is acute pulmonary diseases such as COPD and acute respiratory distress syndrome. We, and our partners in South Korea, are very excited by the potential to develop life improving treatments for patients with these serious respiratory diseases as well as Covid-19.

Seng-ho Jeon, CEO of Daewoong Pharmaceutical and AffyXell Therapeutics, said:

It is very encouraging that AffyXell now has the opportunity to expand the application of its next-generation stem cell platform technology to target viruses. The SARS-CoV-2 neutralising Affimer to be developed in combination with AffyXells cell and gene technology is expected to be an innovative solution for COVID-19 patients suffering cytokine release syndrome.

Daewoong has been also conducting several research programs and clinical trial for Covid19. As the Covid-19 crisis has caused great difficulties worldwide, we will continue to focus our efforts to develop a novel therapeutic agent for Covid-19.

Read more

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Avacta and Integumen collaborate to detect Covid-19 in sewage

Avacta signs distribution deal for Covid-19 self-test under development

Avacta confirms Affimer reagents prevent infection of human cells in model of Covid-19 virus

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Avacta extends partnership with Daewoong Pharmaceutical and AffyXell Therapeutics for Covid-19 stem cell treatments - Cambridge Independent

Three Years After Stem Cell Trial for Heart Failure was Abandoned New Evidence Shows it Works – Diagnostic and Interventional Cardiology

August 4, 2020 - More than three years after a clinical trial was prematurely ended for failing to show progress in healing heart attack scars, the European Heart Journal publishing some surprising results showing that the heart cell treatment does benefit patients.[1]

Data from the ALLSTAR study published Tuesday by the European Heart Journal showed that although infusions of allogeneic cardiac cells (called cardiosphere-derived cells or CDCs) did not appear to shrink the infarct scar after a heart attack, other data from the study show a clear benefit.

Compared with patients who received placebo treatment, patients randomized to receive CDC infusions showed a decrease in the volume of blood in the heart before and after it beats, indicating that the heart had not dilated, as it does progressively in heart failure.

"As it develops heart failure, the heart gets bigger and bigger, like a swelling balloon," said the study's lead author, Raj Makkar, M.D., vice president of cardiovascular innovation and intervention for Cedars-Sinai and the Stephen R. Corday, M.D., chair in interventional cardiology. "One way we can measure the health of a heart is to measure the volume of blood it can hold. The bigger the volume, the more damaged the heart."

The newly analyzed data from the ALLSTAR study, which was sponsored by Capricor Therapeutics, showed that patients given a placebo had hearts that continued to swell, holding larger volumes of blood, while the patients who received CDC infusions had smaller hearts with lower volumes.

The new data results include:

The volume of blood held by the heart was essentially unchanged six months after CDC infusion, but increased by more than a teaspoonful in placebo patients.

A blood protein that measures heart failure severity was reduced in patients who had received CDCs, but not in placebo patients.

The chance that these findings were statistical flukes was only 2 percent.

"To me, these data are very reassuring that there really is therapeutic benefit," said Eduardo Marbn, M.D., Ph.D., executive director of the Smidt Heart Institute. "There is a growing body of evidence that this cell treatment does work."

Results from the earlier CADUCEUS trial, published in The Lancet in 2014, showed that injecting CDCs into the hearts of heart attack survivors significantly reduced infarct size. In 2017, however, the multicenter ALLSTAR study was prematurely halted after six months of data showed no decrease in heart attack scar size, but later analyses revealed the beneficial findings reported here.

"We think we may have chosen the wrong endpoint," said Marbn, the Mark S. Siegel Family Foundation Distinguished Professor, whose discoveries and technologies resulted in CDCs. "This happens in science because you have to design the trial a year or more before you begin, and sometimes you bet on the wrong hors... but that doesnt necessarily mean the therapy is ineffective."

The cells used in the study were CAP-1002, Capricor Therapeutics off-the-shelf, cardiosphere-derived cell (CDC) product candidate. Other clinical trials and case series, in which CDCs were used to treat advanced heart failure, Duchenne Muscular Dystrophy, and COVID-19, also demonstrated positive results. And new studies using CDCs are in the planning stages.

"California is known as the stem cell state, but few technologies being tested in California actually were developed here," said Shlomo Melmed, MB, ChB, executive vice president of Academic Affairs, dean of the Medical Faculty and professor of Medicine. "Increasing evidence-including the results of the large multicenter ALLSTAR trial-validates the potential utility of a cell product which was conceived by a faculty member at Cedars-Sinai, and first tested clinically here."

Read the complete study published by the European Heart Journal.

Disclosures: Except for the cells used in CADUCEUS, the cardiosphere-derived cells used in these studies were derived from donor hearts and provided by Capricor Therapeutics. Marbn developed the process to grow CDCs when he was on the faculty of Johns Hopkins University; the process was further developed at Cedars-Sinai. Capricor has licensed the process from Johns Hopkins and from Cedars-Sinai for clinical and commercial development. Capricor has licensed additional intellectual property from Cedars-Sinai and the University of Rome. Cedars-Sinai and Marbn have financial interests in Capricor.

Reference:

1. Raj R Makkar, Dean J Kereiakes, Frank Aguirre, et al. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR): a randomized, placebo-controlled, double-blinded trial. European Heart Journal, ehaa541, https://doi.org/10.1093/eurheartj/ehaa541.

Link:

Three Years After Stem Cell Trial for Heart Failure was Abandoned New Evidence Shows it Works - Diagnostic and Interventional Cardiology

Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market 2020 Size by Product Analysis, Application, End-Users, Regional Outlook,…

New Jersey, United States,- Market Research Intellect aggregates the latest research on Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market to provide a concise overview of market valuation, industry size, SWOT analysis, revenue approximation, and regional outlook for this business vertical. The report accurately addresses the major opportunities and challenges faced by competitors in this industry and presents the existing competitive landscape and corporate strategies implemented by the Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies market players.

The Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies market report gathers together the key trends influencing the growth of the industry with respect to competitive scenarios and regions in which the business has been successful. In addition, the study analyzes the various limitations of the industry and uncovers opportunities to establish a growth process. In addition, the report also includes a comprehensive research on industry changes caused by the COVID-19 pandemic, helping investors and other stakeholders make informed decisions.

Key highlights from COVID-19 impact analysis:

Unveiling a brief about the Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies market competitive scope:

The report includes pivotal details about the manufactured products, and in-depth company profile, remuneration, and other production patterns.

The research study encompasses information pertaining to the market share that every company holds, in tandem with the price pattern graph and the gross margins.

Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market, By Type

Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market, By Application

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Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market 2020 Size by Product Analysis, Application, End-Users, Regional Outlook,...

IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the Treatment…

BRENTWOOD, Tenn., Aug. 05, 2020 (GLOBE NEWSWIRE) -- IMAC Holdings, Inc. (Nasdaq: IMAC) (the Company or IMAC), a provider of innovative medical advancements and care specializing in regenerative rehabilitation orthopedic treatments without the use of surgery or opioids, today announced the United States Food and Drug Administration (the FDA) approved its investigational new drug application, which IMAC submitted in May 2020, for the use of umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia, or the gradual loss and slowing down of spontaneous body movement, due to Parkinsons disease.

The Company will now initiate enrollment of 15 patients for its Phase 1 trial to evaluate the safety and tolerability of the stem cell product acquired from technology developed by a major research university to treat patients with Bradykinesia due to Parkinsons utilizing intravenous administration of Whartons jelly-derived mesenchymal stem cells. The Company believes that the causes of bradykinesia may be related to an inflammatory response in the body. The Companys new study is designed to confirm this belief and support the Companys long-term strategy for the use of regenerative medicine in combination with physical rehabilitation to reduce the effect of movement-restricting diseases.

Our regenerative rehabilitation centers have long focused on the importance of finding and applying non-opioid, non-surgical solutions to physical ailments in orthopedics. In 2017, our neurosurgeon researched opportunities to apply stem cells to treating Parkinsons, and we put a team together to design a treatment for our neurological patients that simply could not achieve maximum benefit from physical therapy alone, commented Jeffrey Ervin, IMACs Chief Executive Officer. Having received approval to proceed with our study, IMAC is extremely optimistic regarding the potential of this stem cell technology. This has the potential to not only expand proprietary service options for neurological patients, but also advance the way physically debilitating inflammatory conditions are managed as a whole. We would like to thank the FDA for the collaborative process and the partners who helped us achieve this milestone, including patient advocate, Doug Oliver and his team at Regenerative Outcomes.

The Phase 1 trial will consist of three treatment protocols: five patients with bradykinesia due to Parkinsons will receive a low dose intravenous infusion of stem cells, five patients will receive a medium dose intravenous infusion of stem cells and five patients will receive a high dose intravenous infusion of stem cells. The Phase 1 trial will be conducted over 12 months to determine the incidence and extent of adverse events, although the Company will also investigate the efficacy of its stem cell treatment. More information on the clinical trial, including patient criteria, can be found on clinicaltrials.gov.

IMAC will enroll participants from its existing clinics in Illinois, Tennessee, Kentucky and Missouri in its Phase 1 trial. Prospective enrollees may email fdatrial@imacregeneration.com to be considered for the trial. IMACs medical doctors and physical therapists have been trained to administer the treatment and manage the therapy for the clinical trial, which is anticipated to begin in 30 days.

About IMAC Holdings, Inc.

IMAC Holdings was created in March 2015 to expand on the footprint of the original IMAC Regeneration Center, which opened in Kentucky in August 2000. IMAC Regeneration Centers combine life science advancements with traditional medical care for movement restricting diseases and conditions. IMAC owns or manages 16 outpatient clinics that provide regenerative, orthopedic and minimally invasive procedures and therapies. It has partnered with several active and former professional athletes, opening six Ozzie Smith IMAC Regeneration Centers, two David Price IMAC Regeneration Centers, as well as Mike Ditka IMAC Regeneration Centers and a Tony Delk IMAC Regeneration Center. IMACs outpatient medical clinics emphasize its focus around treating sports and orthopedic injuries and movement-restricting diseases without surgery or opioids. More information about IMAC Holdings, Inc. is available at http://www.imacregeneration.com.

# # #

Safe Harbor Statement

This press release contains forward-looking statements. These forward-looking statements, and terms such as anticipate, expect, believe, may, will, should or other comparable terms, are based largely on IMAC's expectations and are subject to a number of risks and uncertainties, certain of which are beyond IMAC's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the skills and experience necessary to meet customers requirements, and its ability to protect its intellectual property. IMAC encourages you to review other factors that may affect its future results in its registration statement and in its other filings with the Securities and Exchange Commission. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this press release will in fact occur.

IMAC Press Contact: Laura Fristoelfristoe@imacrc.com

IMAC Investor Contact:Bret Shapiro(516) 222-2560brets@coreir.com

Source: IMAC Holdings, Inc.

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IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the Treatment...

Strathmore man with MS calls for more Canadian treatment alternatives – CTV Toronto

CALGARY -- Hes just 49 years old and already his mobility is mostly confined to his right hand. If Chad Tashlikowich can halt the progression of his primary-progressive Multiple Sclerosis there, hell consider it a victory.

In 2014 Tashlikowich crowd-funded an $80,000 stem cell treatment in Russia hoping to keep him out of an electric wheel chair. That therapy was unsuccessful.

It really hasnt changed the trajectory at all, he says. Despite the risks and expense, his health didnt improve. Its really poor. Its kinda gone down hill really ever since. I dont think the stem cells did a lot,

Now he wants to try a drug treatment ocrevus recommended to him by American Dr Aaron Boster who specializes in MS, a disease that attacks the central nervous system. The problem is, in Canada the drug is not approved for use on patients with Tashlikowichs form of the disease.

You have a mechanic for your car. And if he doesnt do a good job you get another one. You cant do that with a neurologist, Tashlikowich says.

Dr Luanne Metz is a neurology professor at the University of Calgary. Addressing overseas stem cell transplants, she says she understands how MS patients can see some of the treatments as worth the expense and the risk, given their dire prognoses. But she cautions that not all foreign treatment is what its advertised to be, and even when it is, there are medical reasons why guidelines are what they are in Canada.

The problem is, that when people go outside the country for unapproved therapies, they are often not in regulated situations, says Dr. Metz, adding that stem cell therapy does not help primary-progressive MS. She was not speaking about the efficacy of the drug Ocrevus.

Health Canada regulates drug approvals through a rigorous process. Its up to individual provinces to adopt approved treatments from there.

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Strathmore man with MS calls for more Canadian treatment alternatives - CTV Toronto

Wave of New Therapies Improve Outcomes for Patients with Multiple Myeloma – Dana-Farber Cancer Institute

For many patients with multiple myeloma, a new generation of drugs and drug combinations is producing better outcomes and fewer side effects. In recent months, several novel therapies studied and tested by Dana-Farber scientists have gained approval from the U.S. Food and Drug Administration (FDA) or taken a step toward approval after posting solid results in clinical trials.

The drugs are the fruit of years of research into improving treatment for multiple myeloma, a cancer of white blood cells known as plasma cells in the bone marrow. Many of the new agents are biologically derived made from substances such as proteins and antibodies found in living things and target biological mechanisms in a very specific, targeted fashion. Dana-Farber researchers have played a key role in these efforts.

These are each powerful examples of how next-generation novel therapies translated here at Dana-Farber from bench to bedside are further improving outcomes for our patients, and at a remarkable pace, says Paul G. Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber.

Following a Dana-Farber-led clinical trial, the FDA recently approved the novel drug isatuximab in combination with pomalidomide and dexamethasone for adults with relapsed or refractory (non-responsive) myeloma who have received at least two prior therapies, including lenalidomide and drugs known as proteasome inhibitors. The drug went into trials after laboratory work by Dana-Farbers Yu-Tzu Tai, PhD, and Kenneth Anderson, MD, showed it was active against myeloma cells. In the clinical trial, the three-drug combination lowered the risk that the disease would progress by 40%, compared to pomalidome and dexamethasone alone.

Dana-Farber investigators conducted laboratory research and led the first clinical trial of the drug melflufen plus dexamethasone in patients with relapsed or refractory myeloma. Melflufen is a peptide conjugate drug made of a stub of protein, or peptide, joined to a chemotherapy agent and delivers a toxic payload directly to myeloma cells in a selective, time-sparing approach.

Results from an early-phase clinical trial published in Lancet Oncology showed the drug is active in patients with myeloma and is safe at recommended doses. Unlike the previously used standard drug melphalan, it doesnt cause mucositis inflammation of membranes within the digestive tract or hair loss. The results prompted investigators to launch two larger trials, some of whose results are being processed and are due to be published soon.

In a major study published in Blood, Dana-Farber researchers and their associates found that in patients newly diagnosed with myeloma who are eligible for a stem cell transplant, adding the drug daratumumab to the standard three-drug regimen produced more responses, and deeper responses, than in patients receiving the three-drug therapy alone.

Dana-Farber researchers were involved in the development and initial testing of the drug belantamab mafodotin, which has shown considerable promise in clinical trials and has been granted priority review for approval by the FDA.

An antibody conjugate drug consisting of an antibody that specifically targets myeloma cells and an agent that disrupts cell division, its use was informed by a preclinical trial at Dana-Farber involving Yu-Tzu Tai, PhD, and Kenneth Anderson, MD. Balantamab mafodotin was tested in studies led by Paul Richardson, MD, in patients with relapsed or refractory multiple myeloma whose disease continued to worsen after a stem cell transplant, chemotherapy, or other treatment. In the DREAMM-1 and -2 trials, the drug showed strong anti-myeloma activity with manageable side effects.

After certification in Internal Medicine, Hematology and Medical Oncology, as well as working in Cancer Pharmacology from 1994 onwards at Dana-Farber Cancer Institute (DFCI), Dr. Paul Richardson joined the Jerome Lipper Myeloma Center in 1999, was appointed Clinical Director in 2001, and led the development of several first-generation novel drugs including bortezomib, lenalidomide and pomalidomide for the treatment of multiple myeloma. Subsequent studies have focused on next-generation novel drugs including panobinostat and second-generation proteasome inhibitors including ixazomib. More recently, his clinical innovations have been in the development of the breakthrough monoclonal antibodies elotuzumab and daratumumab for the treatment of both untreated and relapsed myeloma, as well as isatuximab and more broadly, antibody drug conjugates including belantamab mafodotin, as well as other immunotherapeutic strategies. In addition to these agents, he is leading the development of melflufen, a targeted cytotoxic and an first-in-class small molecule inhibitor selinexor, which inhibits XPO-1, a key nuclear export protein, as well as first-in-human studies of cereblon E3 ligase modulators (so called CELMoDs) for the treatment of relapsed and refractory myeloma.

Over the last decade, his major effort has been focused on the development of lenalidomide, bortezomib and dexamethasone (so-called RVD), and its incorporation as part of the Intergroup Francophone Myelome (IFM)/DFCI clinical trial in newly diagnosed patients eligible for stem cell transplant treated with RVD. This regimen has generated an unprecedented response rate, leading to its adoption in this international study, as well as others in the United States and elsewhere. This particular trial incorporates genomic and proteomic evaluation to establish a future platform for tailored therapy and the optimal positioning of stem cell transplant, with results anticipated in 2021-22. Furthermore, RVD has been established as a backbone to which next-generation agents are being added, including elotuzumab, daratumumab and isatuximab, as well as panobinostat.

He has published extensively, having authored or co-authored over 400 original articles and 330 reviews, chapters, and editorials in peer-reviewed journals. In addition to holding positions on the Editorial Boards of leading journals, he is prior Chairman of the Multiple Myeloma Research Consortium (MMRC), Clinical Trials Core, a position held for 5 years as part of a rotating tenure, and for which he continues as a member of the Steering and Project Review Committee. He was also a member of ASCO Hematologic Malignancies Subcommittee for the required one-year term, and then for one year on the ASCO Internet Cancer Information Committee during 2017. He was appointed Chair of the Alliance Myeloma Committee in 2011 and continues in this role.

Honors include the George Canellos Award for Excellence in Clinical Research and Patient Care, and The Tisch Outstanding Achievement Award for Clinical Research, as well as an honorary Fellowship of the Royal College of Physicians (UK), given in recognition for international contributions in multiple Myeloma and stem cell transplantation. He was a co-recipient of the prestigious Warren Alpert Foundation Prize in recognition of the successful therapeutic targeting of the ubiquitin-proteasome pathway in 2012. He was also a co-recipient of the Accelerator Award for contributions to clinical research and patient enrollment in MMRC studies, as well as for the Research Center of the Year Award in 2009, followed by the second award for Center of the Year in 2017. He was ranked by Thomson Reuters Science Watch amongst the top 19 investigators at DFCI for the most highly cited research in 2016. He was the co-recipient of the ASH Ernest Beutler Prize for clinical science and translational research in the development of proteasome inhibition as an effective treatment strategy for multiple myeloma in 2015; the COMY Award for MM research (Paris, France) in 2016, and the prestigious IMF Robert A. Kyle Lifetime Achievement Award in 2017, and the Morse Research Award in 2019.

Read more:

Wave of New Therapies Improve Outcomes for Patients with Multiple Myeloma - Dana-Farber Cancer Institute

ASCO Expert on the Possible Benchmark Analysis of Autologous Transplantation in B-Cell Lymphomas – Cancer Network

Nirav Niranjan Shah, MD, discussed the analysis of autologous transplantation use in patients with relapsed, chemosensitive DLBCL and how it may become a comparator for other clinical trials.

In a data analysis presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting, investigators analyzed whether the use of autologous stem cell transplant in patients with relapsed, chemosensitive DLBCL should remain the standard of care in the CAR T-cell era.

Based on the results of the analysis, it was suggested that autologous transplantation should remain the current standard of care in this patient population.

In an interview with CancerNetwork, Nirav Niranjan Shah, MD, of the Medical College of Wisconsin, spoke about how this analysis could potentially be a benchmark for future studies.

Transcription:

So, we hope to publish our analysis and get it into a peer reviewed journal, so that it becomes available and I think this will be a study that becomes a benchmark that can then be used as a comparator for other clinical trials. I think this gives us a very interesting viewpoint of contemporary data, were PET-CT was used, which is often, you know, a lot of older studies don't utilize PET-CT. So, I think this will be a study that's a benchmark and can be used as a comparison to new therapies that are coming down the road. Because, you know, since, you know, 1980s 1990s, autologous transplant has been that standard of care for relapsed aggressive B-cell lymphoma. And this supports that it should remain that. But it's also possible that over time new therapies do improve upon autologous transplant. But I think this trial will be a nice sort of benchmark to use for future studies.

Excerpt from:

ASCO Expert on the Possible Benchmark Analysis of Autologous Transplantation in B-Cell Lymphomas - Cancer Network

Adipose Derived Stem Cell Therapy Market: Technological Advancement & Growth Analysis with Forecast to 2026 – Chelanpress

Market Study Report has added a new report on Adipose Derived Stem Cell Therapy market that provides a comprehensive review of this industry with respect to the driving forces influencing the market size. Comprising the current and future trends defining the dynamics of this industry vertical, this report also incorporates the regional landscape of Adipose Derived Stem Cell Therapy market in tandem with its competitive terrain.

This Adipose Derived Stem Cell Therapy market report is an integrated document combining a detailed analysis of the industry in question. Combining an in-depth evaluation of this business sphere, the report is also inclusive of an elaborate industry segmentation that contains information about the various segments of the Adipose Derived Stem Cell Therapy market.

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Additionally, the report is inclusive of a detailed outline of this business in tandem with the markets current size and status. Also, the volume and profit parameters have been overviewed in the study. Some pivotal insights pertaining to the regional frame of reference and the competitive spectrum of this industry have been enumerated in the study.

A generic scope of the Adipose Derived Stem Cell Therapy market:

A generic understanding of the competitive landscape

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An all-inclusive understanding of the geographical terrain:

A brief summary of the segmentation:

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Adipose Derived Stem Cell Therapy Market: Technological Advancement & Growth Analysis with Forecast to 2026 - Chelanpress

Cell Therapy Market: Study Navigating the Future Growth Outlook | Osiris Therapeutics, NuVasive, Vericel Corporation – Chelanpress

Cell Therapy Industry Report focuses on Market Influence Factors, Growth Drivers, Restraints, Trends and Opportunities so that Market Players can face any challenges and take advantage of Lucrative Prospects available in the Global Cell Therapy market.

The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries including Medical Device, Pharmaceutical, Healthcare and many more. Trade barriers are further restraining the demand- supply outlook. As government of different regions have already announced total lockdown and temporarily shutdown of industries, the overall production process being adversely affected; thus, hinder the overall Cell Therapy Market globally. This report on Cell Therapy Market provides the analysis on impact on Covid-19 on various business segments and country markets. The report also showcase market trends and forecast to 2027, factoring the impact of Covid -19 Situation.

Request Sample Copy of Cell Therapy Market at: https://www.theinsightpartners.com/sample/TIPRE00009666/

The Emerging Players in the Cell Therapy Market includes Kolon TissueGene, Inc., MEDIPOST, JCR Pharmaceuticals Co. Ltd., Stemedica Cell Technologies, Inc., Osiris Therapeutics, Inc., NuVasive, Inc., Fibrocell Science, Inc., Vericel Corporation, Cells for Cells, Celgene Corporation, etc.

Cell Therapy Market Definitions and Overview:

Cell therapy (CT) is the process of transplanting human cells to replace or repair damaged tissue or cells. Various methods can be used to carry out cell therapy. For instance, hematopoietic stem cell transplantation, also known as bone marrow transplant, is the most widely used cell therapy. It is used to treat a variety of blood cancers and blood-related conditions.

Cell therapy market is expected to grow due to factors such as increasing the biotechnology industry, rising healthcare expenditure, growing incidences of chronic diseases, and others. The market is expected to have growth opportunities in the emerging region as they are developing their genetic sectors rapidly.

The research provides answers to the following key questions:

Competitive scenario:

The study assesses factors such as segmentation, description, and applications of Cell Therapy industries. It derives accurate insights to give a holistic view of the dynamic features of the business, including shares, profit generation, thereby directing focus on the critical aspects of the business.

Scope of the Report

The research on the Cell Therapy market focuses on mining out valuable data on investment pockets, growth opportunities, and major market vendors to help clients understand their competitors methodologies. The research also segments the Cell Therapy market on the basis of end user, product type, application, and demography for the forecast period 20212027. Comprehensive analysis of critical aspects such as impacting factors and competitive landscape are showcased with the help of vital resources, such as charts, tables, and infographics.

Cell Therapy Market Segmented by Region/Country: North America, Europe, Asia Pacific, Middle East & Africa, and Central & South America

Major highlights of the report:

All-inclusive evaluation of the parent market

Evolution of significant market aspects

Industry-wide investigation of market segments

Assessment of market value and volume in past, present, and forecast years

Evaluation of market share

Study of niche industrial sectors

Tactical approaches of market leaders

Lucrative strategies to help companies strengthen their position in the market

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Cell Therapy Market: Study Navigating the Future Growth Outlook | Osiris Therapeutics, NuVasive, Vericel Corporation - Chelanpress

Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 – Chelanpress

Global Stem Cell Therapy Market Analysis with forecast period 2020 to 2025 provides an in-depth analysis of market growth factors, future assessment, country-level analysis, Stem Cell Therapy industry distribution, and competitive landscape analysis of major industry players. The research report of global Stem Cell Therapy market report offers the extensive information about the top most makers and sellers who are doing great and are directly working right in the market now and which have great market area according to the country and region and other aspects that affect the growth of any company or industry. The report exhibits both Stem Cell Therapy market quantitative as well as qualitative data with tables and figures displayed in the form of bar graphs, and pie charts.

A leading research firm, Adroit Market Research added a latest industry report on Global Stem Cell Therapy Market consisting of 110+ pages during the forecast period and Stem Cell Therapy Market report offers a comprehensive research updates and information related to market growth, demand, opportunities in the Market.

Get sample copy of Stem Cell Therapy Market report @https://www.adroitmarketresearch.com/contacts/request-sample/691

Global Stem Cell Therapy market study includes a thorough analysis of the overall competitive landscape and the company profiles of leading market players involved in the global Stem Cell Therapy market. Moreover, crucial specifics such as growth drivers as well as the expected growth rate of the Stem Cell Therapy market during the forecast period are included in the report. The report also details the potential growth aspects along with the restraints of this industry vertical. Further, the presented study offers accurate insights pertaining to the different segments of the global Stem Cell Therapy market such as the market share, value, revenue, and how each segment is expected to fair post the COVID-19 pandemic.

Read complete report with TOC at:https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market

Global Stem Cell Therapy market report estimates the revenue, industry size, types, applications, players share, production volume, and consumption to get an understanding of the demand and supply chain of the market. The report encompasses technical data, raw materials, volumes, and manufacturing analysis of the global Stem Cell Therapy market. The research study delivers future projections for prominent opportunities based on the analysis of the subdivision of the market. The study meticulously unveils the market and contains substantial details about the projections with respect to industry, remuneration forecast, sales graph, and growth prospects over the forecast timeline.

Global Stem Cell Therapy market is segmented based by type, application and region.

Based on Type, the market has been segmented into:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Based on application, the market has been segmented into:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

The market overview section highlights the Stem Cell Therapy Market definition, taxonomy, and an overview of the parent market across the globe and region wise. To provide better understanding of the global Stem Cell Therapy Market, the report includes in-depth analysis of drivers, restraints, and trends in all major regions namely, Asia Pacific, North America, Europe, Latin America and the Middle East & Africa, which influence the current market scenario and future status of the global Stem Cell Therapy Market over the forecast period.

Key Highlights Questions of Stem Cell Therapy Market:What will be the size of the global Stem Cell Therapy market in 2025?Which product is expected to show the highest market growth?Which application is projected to gain a lions share of the global Stem Cell Therapy market?Which region is foretold to create the most number of opportunities in the global Stem Cell Therapy market?Will there be any changes in market competition during the forecast period?Which are the top players currently operating in the global Stem Cell Therapy market?

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Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 - Chelanpress

Nerve Repair and Regeneration Market worth $9.7 billion by 2025 – Exclusive Report by MarketsandMarkets – PRNewswire

CHICAGO, Aug. 4, 2020 /PRNewswire/ -- According to the new market research report "Nerve Repair and Regeneration Marketby Products (Nerve Conduits, Nerve Wraps, Vagus Nerve Stimulation, Sacral Nerve Stimulation, Spinal Cord Stimulation, TENS, TMS), Application (Neurorrhaphy, Nerve Grafting, Stem Cell Therapy) and Region - Global Forecast to 2025", published by MarketsandMarkets,the global Nerve Repair and Regeneration Marketsize is projected to reach USD 9.7 billion by 2025 from USD 6.3 billion in 2020, growing at a CAGR of 9.1% from 2020 to 2025.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=883

The Growth in Nerve Regeneration Marketis driven mainly by high incidence of nerve injuries, the growing prevalence of neurological disorders, and rising government support for neurologic disorder research.

Neurostimulation and Neuromodulation Devices accounted for the largest share of the market, by product, in 2019

By product, the nerve repair market is segmented into neurostimulation and neuromodulation devices and biomaterials. The neurostimulation and neuromodulation devices segment is segment is expected to grow at the highest growth rate during the forecast period. The large market share of this segment is driven mainly by rising government expenditure for neurologic disorders, and favorable reimbursement .

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By neurostimulation and neuromodulation application, internal neurostimulation and neuromodulation accounted for the largest market share in 2019

Based on the neurostimulation and neuromodulation application , the Nerve Regeneration Market is segmented the neurostimulation and neuromodulation devices market is segmented into internal neurostimulation and neuromodulation applications and external neurostimulation and neuromodulation applications. The internal neurostimulation and neuromodulation segment is estimated to register the highest CAGR during the forecast period. This can primarily be attributed to the increasing incidence of neurological disorders across the globe.

By Biomaterials application, direct nerve repair/neurorrhaphy accounted for the largest market share in 2019

Based on application, the biomaterials market is segmented into direct nerve repair/neurorrhaphy, nerve grafting, and stem cell therapy. In 2019, the direct nerve repair segment accounted for the largest share of the market. This can be attributed to the increasing incidence of neurological disorders across the globe.

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North America was the largest regional market for Nerve Repair Market in 2019

The Nerve Repair And Regeneration Market is segmented into five major regions, namely, Europe, North America, the Asia Pacific, Latin America, and Middle East & Africa. In 2019, North America accounted for the largest share of the Nerve Regeneration Market, followed by Europe. The rising incidence of neurological disorders, favorable reimbursement policies, and the strong presence of industry players in the region are the major factors driving the growth of the market in North America.

Some of the major players operating in the global Nerve Repair And Regeneration Market include Medtronic, PLC. (Ireland), Boston Scientific Corporation (US), Abbott Laboratories (US), AxoGen, Inc. (US), Baxter International, Inc. (US), LivaNova, PLC. (UK), Integra LifeSciences (US), Polyganics (Netherlands), NeuroPace, Inc. (US), Soterix Medical, Inc. (US), Nevro Corp (US), Synapse Biomedical, Inc. (US), Aleva Neurotherapeutics (Switzerland), Collagen Matrix, Inc. (US), KeriMedical (Switzerland), BioWave Corporation (US), NeuroSigma (US), tVNS Technologies GmbH(Germany), and GiMer Medical (Taiwan).

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Personalized Cell Therapies Market to Show Incredible Growth by 2025 – Owned

Personalized Cell Therapies MarketInsights 2020 is an expert and top to bottom investigation on the momentum condition of the worldwide Personalized Cell Therapies industry with an attention on the Global market. The report gives key insights available status of the Personalized Cell Therapies producers and is an important wellspring of direction and course for organizations and people keen on the business. By and large, the report gives an inside and out understanding of 2020-2025 worldwide Personalized Cell Therapies market covering extremely significant parameters.

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Key Players in Personalized Cell Therapies Market arePCT Cell Therapy Services, LLC (U.S),S. Stem Cell, Inc. (U.S),Bellicum Pharmaceuticals, Inc. (U.S),Saneron CCEL Therapeutics, Inc. (U.S),StemGenex (U.S),Vericel Corporation.(U.S),Cytori Therapeutics Inc.(U.S.),MolMed S.p.A. (Italy).

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Global Personalized Cell Therapies Market report is a comprehensive study of the global market and has been recently added by PrecisionBusinessInsights to its extensive database. Augmented demand for the global market has been increased in the last few years. This informative research report has been scrutinized by using primary and secondary research. The Global Personalized Cell Therapies Market is a valuable source of reliable data including data of the current market.

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This research report represents a 360-degree overview of the competitive landscape of the Global Personalized Cell Therapies Market. Furthermore, it offers massive data relating to recent trends, technological, advancements, tools, and methodologies. The research report analyzes the Global Personalized Cell Therapies Market in a detailed and concise manner for better insights into the businesses.

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The report analyses the impact of socio-political environment through PESTLE Analysis and competition through Porters Five Force Analysis in addition to recent technology advancements and innovations in the market.

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High-throughput 3D screening for differentiation of hPSC-derived cell therapy candidates – Science Advances

Abstract

The emergence of several cell therapy candidates in the clinic is an encouraging sign for human diseases/disorders that currently have no effective treatment; however, scalable production of these cell therapies has become a bottleneck. To overcome this barrier, three-dimensional (3D) cell culture strategies have been considered for enhanced cell production. Here, we demonstrate a high-throughput 3D culture platform used to systematically screen 1200 culture conditions with varying doses, durations, dynamics, and combinations of signaling cues to derive oligodendrocyte progenitor cells and midbrain dopaminergic neurons from human pluripotent stem cells (hPSCs). Statistical models of the robust dataset reveal previously unidentified patterns about cell competence to Wnt, retinoic acid, and sonic hedgehog signals, and their interactions, which may offer insights into the combinatorial roles these signals play in human central nervous system development. These insights can be harnessed to optimize production of hPSC-derived cell replacement therapies for a range of neurological indications.

Stem cellsincluding adult and pluripotent subtypesoffer tremendous clinical promise for the treatment of a variety of degenerative diseases, as these cells have the capacity to self-renew indefinitely, mature into functional cell types, and thereby serve as a source of cell replacement therapies (CRTs). Human pluripotent stem cells (hPSCs) are of increasing interest for the development of CRTs due to their capacity to differentiate into all cell types in an adult, for which adult tissuespecific stem cells may, in some cases, not exist or may be difficult to isolate or propagate (1). For example, one potential CRT enabled by hPSCs is the treatment of spinal cord injury (SCI) with oligodendrocyte progenitor cells (OPCs). These hPSC-OPCs have recently advanced to a phase 2 clinical trial for the treatment of SCI (2) and are being considered for additional myelin-associated disorders in the central nervous system (CNS), including adrenoleukodystrophy, multiple sclerosis (3, 4), and radiation therapyinduced injury (5). In parallel, hPSC-derived midbrain dopaminergic (mDA) neurons are under consideration for Parkinsons disease therapy (6, 7).

The promise of hPSC-derived therapeutics such as hPSC-OPCs or mDA neurons motivates the development of manufacturing processes to accommodate the potential associated clinical need. For example, approximately 250,000 patients in the United States suffer from some form of SCI, with an estimated annual incidence of 15,000 new patients (8). Human clinical trials involving hPSC-OPCs have used dosages of 20 million cells per patient (9), such that the hypothetical demand would be over 1 trillion differentiated OPCs. It is therefore imperative to develop systems to enable discovery of efficient and scalable differentiation protocols for these therapies.

Differentiation protocols to direct hPSCs into functional OPCs (10, 11) have been developed to approximate the signaling environment at precise positions within the developing spinal cord. Positional identity of cells is guided patterning cues that form intersecting gradients along the dorsoventral axis, such as Sonic hedgehog (SHH), and rostrocaudal axis, such as retinoic acid (RA). In addition, certain cues are present along both axes, such as Wnts (1215). These signaling environments vary over time as the embryo develops (16, 17). However, translating this complex developmental biology to an in vitro culture requires optimization of a large combinatorial parameter space of signaling factor identities, doses, durations, dynamics, and combinations over many weeks to achieve efficient yield of the target cell type, and there remains open questions about the impact of cross-talk between patterning cues on the expression of cellular markers present in OPCs such as transcription factors Olig2 and Nkx2.2 (18). Strategies to derive OPCs and other potential CRTs from hPSCs have shown steady progress, especially with application of high-throughput screening technology (1921); however, current production systems for hPSC-derived CRTs involve two-dimensional (2D) culture formats that are challenging to scale (2228).

More recently, 3D culture systems have demonstrated strong potential for a larger scale and higher yield (29) of hPSC expansion and differentiation than 2D counterparts, as well as compatibility with good manufacturing practice (GMP) standards (3033). While high-throughput systems for screening 3D cell culture environments have been applied to basic biological studies of hPSC proliferation (34), we envision that this technology could additionally be applied toward systematically optimizing production strategies for CRTs to accelerate the pace of their discovery and development toward the clinic while simultaneously uncovering new interactions among signaling cues that affect cell fate. Here, we harness the powerful capabilities of a uniquely structured microculture platform (35, 36), to screen dosage, duration, dynamics, and combinations of several cellular signaling factors in 3D for hPSC differentiation (Fig. 1). The independent control of gel-encapsulated cells (on pillar chip) and media (in well chip) enables simultaneous media replenishment for more than 500 independent microcultures in a single chip. Furthermore, we use custom hPSC reporter cell lines (37) to enable live imaging of proliferation and differentiation of OPCs for over 80 days on the microculture chip. One thousand two hundred combinatorial culture conditions, amounting to 4800 independent samples, were screened while consuming less than 0.2% of the reagent volumes of a corresponding 96-well plate format. Furthermore, the robust dataset enabled statistical modeling to identify relative differentiation sensitivities to, and interactions between, various cell culture parameters in an unbiased manner. Last, we demonstrate the generalizability of the platform by applying it toward a screen for differentiation of tyrosine hydroxylaseexpressing dopaminergic neurons from hPSCs.

(A) A micropillar chip with cells suspended in a 3D hydrogel is stamped to a complementary microwell chip containing isolated media conditions to generate 532 independent microenvironments. One hundred nanoliters of hPSCs suspended in a hydrogel is automatically dispensed onto the micropillars, and 800 nl of media is automatically dispensed into the microwells by a robotic liquid handling robot programmed to dispense in custom patterns. The independent substrate for cells and media enables screens of combinations of soluble cues at various dosages and timings. Scale bar, 1 mm. (B) Timeline of exogenous signals for in vitro 3D OPC differentiation from hPSCs and anticipated cellular marker expression along various differentiation stages.

Initially, we assessed whether hPSCs could be dispensed in the microculture platform system uniformly and with high viability. Quantification of total, live, and dead cell counts across the microchip indicates uniform culture seeding and cell viability at the initiation of an experiment (fig. S1).

We then used a custom-made Nkx2.2-Cre H9 reporter line, which constitutively expresses DsRed protein but switches to green fluorescent protein (GFP) expression upon exposure to Cre recombinase, to longitudinally monitor proliferation and differentiation of hPSCs to Nkx2.2+ oligodendrocyte progenitors in 3D on the microchip platform. A small range of culture conditions from previously published protocols of OPC differentiation were selected for an initial, pilot differentiation experiment, and the GFP expression was quantified after 21 days of differentiation. Cell morphology changes accompanying neural lineage commitment and maturation were clearly observed at later stages in the 3D differentiation (movie S1 and fig. S2) as cultures were maintained and monitored for up to 80 days on the microchip. We then developed fluorescence image analysis pipelines for quantification of nuclear and cytoplasmic marker expression via immunocytochemistry for endpoint analyses at various times (fig. S3). Together, these results support the robust and long-term culture potential and cellular marker expression readout of this miniaturization methodology for hPSC differentiation screening.

hPSC seeding density. We first focused on parameters within the first week of 3D differentiation into OPCs (Fig. 2A). The importance of autocrine, paracrine, and juxtacrine signaling mechanisms among cells in many systems led us to anticipate that the density of cells at the start of differentiation could affect the early neural induction efficiency and, consequently, the efficiency of OPC differentiation. We therefore demonstrated the ability of this microculture platform to test a range of initial hPSC seeding densities on day 2 (fig. S1) and assessed the effect of seeding density on Olig2 expression. We observed notable differences in levels of cell-to-cell adhesion in hPSC cultures by day 0, 2 days after initial seeding (Fig. 2Bi). Then, after 15 days of differentiation, we observed a trend that lower hPSC seeding density, between 10 and 50 cells per pillar, increased OPC specification slightly (Fig. 2Bii).

(A) Timeline of key parameters in the early phase of OPC differentiation. (B) i. Bright-field images of 3D H9 microculture sites at day 0 seeded with varying cell densities and the immunocytochemistry images of Olig2 (red) expression at day 15. Scale bar, 100 microns. ii. Quantification of day 15 Olig2 expression with respect to seeding density and SAG dose. *P value < 0.05 using Tukeys Method for multiple comparisons. (C) i. Montage of 360 fluorescence confocal images representing 90 unique differentiation timelines on a single microchip stained for Hoechst (blue) and Olig2 (red) after 21 days of differentiation. ii. Trends in Olig2 expression at days 15 and 21 in various CHIR and RA concentrations and durations (short CHIR, days 0 to 1; long CHIR, days 0 to 3). Error bars represent 95% confidence intervals from four technical replicates.

Timing of SMAD inhibition relative to RA and Wnt signals. The formation of the neural tube in human development (12) results from cells in the epiblast being exposed to precisely timed developmental signals such as Wnt (38) and RA that then instruct neural subtype specification (39). This led us to hypothesize that the overall differentiation efficiency of hPSCs to OPCs in this 3D context in vitro would be sensitive to the timing at which RA and Wnt signals were introduced during neural induction. Therefore, we induced neuroectodermal differentiation of hPSCs via inhibition of bone morphogenetic protein (BMP) signaling using the dual SMAD inhibition approach (40), with LDN193189 (hereafter referred to as LDN) and SB431542 (hereafter referred to as SB), and tested a range of times (0, 2, and 4 days) at which RA and Wnt signals (by CHIR99021, hereafter referred to as CHIR) were introduced into the culture. We observed a strong correlation between early addition of RA/CHIR and OPC specification such that combined exposure of RA and CHIR signals with SMAD inhibition on day 0 resulted in up to sixfold higher Olig2 expression in some cases (fig. S4), potentially implicating an important role of synchronized exposure of RA and CHIR signals with SMAD inhibition for specifying Olig2+ progenitors. For subsequent experiments, we kept the timing of RA and CHIR addition at day 0 and evaluated how the dose and duration of these signals may affect Olig2+ specification.

Dose and duration of key signaling agonists. We examined the combinatorial and temporal effects of three signaling cues that form gradients across intersecting developmental axes in the neural tube to influence specification of oligodendrocyte progenitors: RA (present along the rostrocaudal axis of the CNS development), SHH (41) (a morphogen that patterns the dorsoventral axis of the developing CNS and is activated by smoothened agonist, hereafter referred to as SAG), and Wnt (present along both the rostrocaudal and dorsoventral axes). Because OPC specification is likely sensitive to the relative concentrations of these cues, for example, given the importance of morphogen gradients in oligodendrocyte differentiation in the developing neural tube (12), we assessed the Olig2 expression resulting from a full factorial combinatorial screen of these cues (fig. S5). Most notably, we observed positive correlations in Olig2 expression in response to increasing RA dose and increasing duration of CHIR exposure from days 0 to 4 of differentiation (Fig. 2C). Without CHIR, an increase in RA from 10 to 1000 nM resulted in a 10-fold increase of Olig2 expression by day 21. A similar 10-fold increase in Olig2 expression was observed at an RA concentration of 100 nM if CHIR was present for the first 3 days of differentiation (Fig. 2C). Analysis of variance (ANOVA) analysis revealed a strong effect size for RA when added early in the differentiation, as well as an interaction between RA dose and longer CHIR duration, in specifying Olig2+ cells in this 3D context (fig. S5), consistent with previous work conducted in 2D in vitro formats (19, 42).

In other developmental systems, the activity of the Wnt signaling pathway was observed to be biphasic (43), whereby activation of the pathway initially enhances cardiac development but later represses it. As this complex signaling profile has been applied to enhance cardiomyocyte differentiation protocols in vitro (44), we analogously investigated whether adding antagonists of key signaling pathways after pathway activation could further enhance the OPC differentiation efficiency by adjusting the dorsoventral and rostrocaudal positioning in vitro. Maintaining the 5 M CHIR for days 0 to 3 from the previous experiment, we used IWP-2 (an inhibitor of the Wnt pathway), GANTT61 (an antagonist of SHH signaling), and DAPT (a Notch pathway antagonist) (Fig. 3A) to inhibit endogenous autocrine/paracrine and/or basal signaling. We used a full factorial analysis of these cues to additionally probe for combinatorial interactions among the pathway inhibitors.

(A) Timing of addition for three inhibitory signaling cuesGANTT61, IWP-2, and DAPTin the OPC differentiation protocol. (B) i. Olig2+, Nkx2.2+, and the proportion of total Olig2+ that are Nkx2.2+/Olig2+ cells in at day 21 in response to full factorial combinations of selected novel signaling antagonists. ii. Immunocytochemistry images of costained Olig2 (red) and Nkx2.2 (green) cells. Scale bar, 100 m. Error bars represent 95% confidence intervals from four technical replicates.

To further refine the markers for OPC specification, we measured Nkx2.2 expression in addition to Olig2 and quantified the proportion of cells coexpressing both OPC markers. Most notably, a significant decrease in %Olig2 was observed in response to Notch inhibitor DAPT across all conditions tested (Fig. 3Bi). The same trend was not observed with respect to %Nkx2.2. This result could point to a role for Notch signaling in maintaining or promoting specification of Olig2+ progenitorsa hypothesis not previously examined to our knowledgeand serves as preliminary evidence to test Notch agonists such as DLL-4 in follow-up studies of OPC optimization. This effect may be mediated by an interaction with the SHH pathway (45).

A slight increase in %Olig2+ cells was detected with increasing Wnt inhibitor IWP-2 dose when no SHH inhibitor GANTT61 was present, as was a slight increase in %Nkx2.2+ cells as a function of increasing IWP-2 and GANTT61 dose, pointing to a potential interaction between these two cues in inducing Nkx2.2 expression. The highest proportion of Olig2+Nkx2.2+ cells was observed at the highest IWP-2 and GANTT61 doses and was not influenced by DAPT exposure (Fig. 3Bii). As CHIR was present between days 0 and 3 in the differentiation, it seems that the role of Wnt signaling changes during the 21-day differentiation window of hPSCs to OPCs in that initially (days 0 to 3) it promotes OPC differentiation but shifts to an inhibitory role at later stages (days 4 to 21). To examine the extent of reproducibility of these findings, we tested the effect of temporal modulation of Wnt signals in a human induced pluripotent stem cell (hiPSC) line, TCTF, and found that the general trend of activation followed by inactivation of Wnt signaling would increase the proportion of Olig2+ cells at day 21 (fig. S6).

Although the levels of key signaling cues may vary temporally within the natural developmental environment of certain target cell types, such as within the neural tube where a dynamic SHH gradient along the dorsoventral axis patterns pMN development (16, 17), the dosage of signaling cues in the media for in vitro stem cell differentiation protocols is often applied at a constant level throughout the culture period. On the basis of this discrepancy, we applied the micropillar/microwell chip to screen through numerous temporal profiles of SAG, as well as RA due to its analogous role along the rostrocaudal axis during spinal cord development, by dividing the signal window into early and late stages that were dosed independently to form constant, increasing, and decreasing dose profiles over time (Fig. 4A). To gain additional insights into OPC marker expression, we measured Tuj1 expression and calculated the proportion of Olig2+ cells that coexpressed Tuj1 to potentially identify any modulators of the balance between Olig2+ cells that proceed down a motor neuron fate (which are both Olig2+ and Tuj1+) versus an oligodendrocyte fate (Olig2+/Nkx2.2+).

(A) Timeline of early and late windows for RA and SAG exposure. (B) i. Hierarchical cluster analysis of standardized (z score) phenotypic responses to temporal changes in RA and SAG dose during OPC differentiation. ii. Representative immunocytochemistry images of each major category of endpoint population phenotype mix of Olig2 (red), Nkx2.2 (green), and Tuj1 (orange) expression. Scale bar, 100 m. iii. Olig2, Nkx2.2, and coexpression of Olig2+Nkx2.2+ and Olig2+Tuj1+ at day 15 in response to time-varying doses of SAG. Error bars represent 95% confidence intervals from four technical replicates. *P value < 0.05.

To consider all measured phenotypes simultaneously, we applied a hierarchical cluster analysis from which we were able to identify several patterns. A broad range of endpoint phenotype proportions of Olig2, Nkx2.2, and Tuj1 was found to result from varying the temporal dosing of only two signaling cues, RA and SAG, pointing to a very fine sensitivity to temporal changes in signal exposure in these populations. Four categories of the endpoint marker expression profiles were created to further interpret the cluster analysis. Categories 1 and 2 are composed of phenotypes ranking low on OPC progenitor fate (low Olig2 and/or Nkx2.2 expression), all of which shared the low dosing of RA at 0.1 M between days 2 and 21 of the differentiation, further emphasizing the strong impact of RA on OPC yield. In contrast, category 3composed of the highest Olig2 and Nkx2.2 expression as well as Olig2+Nkx2.2+ proportioncorrelated with the highest dose of early SAG but had negligible differences across doses of late SAG (Fig. 4Biii, and fig. S7). Last, category 4 points to a biphasic relationship of Nkx2.2 expression as a function of RA dosage, where a high dose of RA of 1 M in the late stage of differentiation resulted in lower Nkx2.2 expression (fig. S8) compared with a consistent RA of 0.5 M throughout the entire differentiation. It appears that Olig2 and Nkx2.2 undergo maxima under different RA dosage profiles (fig. S8), and therefore, the use of coexpressing Olig2+Nkx2.2+ cells as the main metric when optimizing OPC differentiation may be most suitable.

We sought a comprehensive, yet concise, analysis to describe individual and combinatorial effects of all 12 culture parameters (e.g., signal agonist and antagonist dosages and timings) on the results of the more than 1000 unique differentiation conditions involved in this study. To this end, we fit generalized linear models to correlate the expression and coexpression of Olig2, Nxk2.2, and Tuj1 to individual input parameters within the 12 culture parameters involved in this study, and the 132 pairwise interactions between them. First, we identified significant parameters of interest for each phenotype measured using a factorial ANOVA (fig. S9). After applying a Benjamini and Hochberg false discovery rate correction for multiple comparisons (46), we fit an ordinary least squares model of the statistically significant terms to the phenotype of interest. The parameter coefficients were analyzed as a measure of relative influence on the expression of a certain endpoint phenotype, such as Olig2+Nkx2.2+ cells, and could be interpreted as a sensitivity analysis of key parameters on the OPC specification process. The most significant parameters were then sorted by their effect magnitude (Fig. 5B).

(A) Identification of statistically significant culture parameters using a factorial ANOVA of all single and pairwise effects on Nkx2.2 expression subject to the Benjamini and Hochberg false discovery rate (B&H FDR) correction. (B) Effect magnitude of significant culture parameters for i. Nkx2.2 expression, ii. Olig2 expression, iii. and coexpression of Olig2 and Nkx2.2. (C) i. Diagram summarizing results and effect magnitude of significant culture parameters for Olig2 and Nkx2.2 coexpression within the Olig2+ population and ii. effect magnitude of significant culture parameters for Olig2 and Tuj1 coexpression within the Olig2+ population.

RA, a rostrocaudal patterning cue, was among the most impactful parameters in this study for Olig2 and Nkx2.2 expression (Fig. 5Bi and ii). In particular, a high RA dose (1 M) early in the differentiation (days 0 and 1) emerged as the most influential culture parameter in the acquisition of OPC fate (coexpression of Olig2 and Nkx2.2) (Fig. 5Bi to iii). In addition, the dose of SAG from days 4 to 10 of differentiation exerted a markedly more significant impact on OPC fate induction than from days 10 to 21 of differentiation, in line with the previous analysis (Fig. 4). IWP-2 and GANT were observed to correlate positively with coexpression of Olig2 and Nkx2.2 as well. Furthermore, this analysis identified two cases of culture parameters interacting in a synergistic manner to promote OPC differentiation. First, higher doses of RA during days 0 to 2 followed by SAG during days 4 to 10 were found to promote higher Nkx2.2 expression. In addition, longer CHIR duration (from days 0 to 4) along with higher GANT dose promoted coexpression of Nkx2.2 and Olig2.

We created a new differentiation protocol from the parameters isolated in this screen to have the most influence in specifying Olig2+Nkx2.2+ progenitors (Fig. 5Biii) and carried out the differentiation into the later stages of OPC maturation in a larger-scale format to assess the ability of this optimized protocol to create mature oligodendrocytes. The protocol was able to produce platelet-derived growth factor receptor (PDGFR)expressing cells by day 60 across multiple hPSC lines, as well as O4-expressing cells by day 75 and myelin basic protein (MBP) expressing cells and myelination ability at day 100 (fig. S10).

The OPC screening identified new conditions that affect cell differentiation, and we then sought to demonstrate the generalizability of this approach by conducting a different study. Specifically, we screened 90 unique hPSC differentiation protocols for tyrosine hydroxylase+ mDA neurons (Fig. 6). Exposure of CHIR was divided into three periods (early, middle, and late), and dosage for each period was varied independently. This screening strategy uncovered a key window of CHIR competence between days 3 and 7 (early), a negligible effect of CHIR between days 8 and 11 (middle), and an inhibitory effect of CHIR between days 12 and 25 (late) of mDA differentiation. These data further illustrate the existence of biphasic signaling activity during the differentiation process and underscore the need to improve the temporal dosing of several signaling agonists across a range of hPSC-derived CRTs.

(A) Timeline of small-molecule addition for differentiation of mDA neurons from hPSCs. (B) Montage of 90 unique differentiation timeline to test temporal profiles of CHIR dose stained for tyrosine hydroxylase (TH) and Tuj1. Scale bar, 1 mm. (C) Immunocytochemistry images of i. low, ii. medium, and ii. high proportions of TH+ (yellow) neurons (red) dependent on the temporal profile of CHIR exposure. Scale bar, 100 m.

The clinical emergence of several cell-based therapy candidates (47) is encouraging for human diseases/disorders that currently have no effective small molecule or biologic-based therapy. As research and development into CRT candidates continues to progress, cell production has emerged as a bottleneckas delivery vectors recently have in gene therapyand improved tools will be necessary to enable higher quality and yield in cell manufacturing. Although previous studies have reported ~90% hPSC differentiation efficiency into Olig2+ progenitors using 2D culture formats (19), the 2D culture format constrains the space in which cells can expand to the surface area of the culture plate that limits the overall cell yield that can be produced. The adoption of scalable 3D culture formats, which have demonstrated the ability to produce up to fivefold higher quantities of cells per culture volume, shows promise in surpassing limits of 2D cell expansion (2933) and could result in a higher overall production quantity of target cells even if differentiation efficiencies were lower than what has been reported in 2D. Therefore, the 3D screening and analysis strategy presented here is relevant for numerous emerging CRT candidates for which conversion of a stem or progenitor cell, such as a hPSCs (48), to a therapeutically relevant cell type requires searching through a large in vitro design space of doses, durations, dynamics, and combinations of signaling cues over several weeks of culture.

Notably, to emulate a ubiquitous and naturally occurring phenomenon in organismal development (16, 49), we dynamically varied key signaling cues in our screening strategy, tuning dosage over time. These analyses revealed new biological insights into the dynamic process by which cell competence to signals and fate are progressively specified (50). For example, by applying this platform to screen through several dynamic signaling levels simultaneously, we observed that the differentiation toward Nkx2.2+ progenitors is very sensitive to the dose of RA between days 0 and 1 and the dose of SAG between days 4 and 10. After these respective time windows, the effect of each respective signal in producing Nkx2.2+ progenitors is decreased, potentially pointing to a decrease in cellular competence to each of these signals over the course of OPC development. These cases of stage-specific responses to signaling cues, revealed by our screening platform, create a new dimension for future optimization of cell production.

To effectively navigate this enormous parameter space across doses, durations, dynamics, and combinations of signaling cues and resulting differentiation outcomes, we developed a robust sensitivity analysis strategy that can rank effect sizes to reveal which parameters should be the focus of optimization to modulate expression of target markers of interest (49) and, by contrast, which parameters exert minimal impact and can thus be neglected. For example, titration of RA dose will exert a significantly higher impact on differentiation efficiency than several other culture parameters combined. Furthermore, insights from this study could reduce the necessary quantity of SHH agonist by more than 50% to achieve similar levels of OPC differentiation. As these cell production processes translate from bench scale to industrial scale, awareness of key parameters that influence critical quality attributes (18) of the cell therapy product (such as expression of specific cellular markers) will be a necessary step in reliably producing these therapeutic cell types at scale for the clinic (51).

The wealth of combinatorial and temporal signaling patterns identified in this study can be analyzed in the context of CNS development as well. We observed a potential case of biphasic activity for the Wnt signaling pathway as both activation and inhibition appeared to increase expression of OPC markers Nkx2.2 and Olig2. In particular, this effect was seen with initial Wnt activation by CHIR during days 0 to 3 of OPC differentiation followed by inhibition by IWP-2 during days 4 to 21 of OPC differentiation. The Wnt pathway has shown stage-specific activity in cardiac and hematopoietic development (43, 44), which may thus be a conserved feature across several developmental systems. Wnt signals play an important role in the gastrulation of the embryo to form the primitive streak (38), yet in the subsequent stages of spinal cord development, Wnt signals induce a dorsalizing effect (52), whereas oligodendrocytes originate from the motor neuron domain on the ventral side. Therefore, suppressing endogenous Wnt signals in vitro after initial activation of Wnt may better recapitulate the natural developmental signaling environment of developing oligodendrocytes. Alternatively, as Wnt signals also play a role in rostrocaudal patterning of the CNS, these insights may further point toward a rostrocaudal region of the CNS during this developmental window that is optimal to recapitulate in vitro for OPC production. The oligodendrocytes created through this protocol, which expressed OTX2 at day 10 (fig. S2C), may resemble OPCs in the midbrain/hindbrain region. It is conceivable that exposure to the Wnt antagonist, IWP-2, induced a position rostral to the spinal cord during the differentiation window. This biphasic Wnt trend was seen again in our analysis of differentiation of mDA neurons, underscoring that stage-specific responses may be a conserved feature across several differentiation processes aiming to recapitulate a precise cellular position across several axes of patterning signals during natural development.

Furthermore, the statistical model identified an interaction between RA and SAG (an SHH agonist) in the early differentiation windows for specifying Nkx2.2+ progenitors (Fig. 5B), which has not been previously reported to our knowledge. In the developing CNS, RA signaling influences rostrocaudal positional identity, whereas SHH signaling specifies dorsoventral positional identity. Therefore, this statistical interaction found in the screen may represent intracellular cross-talk between the RA and SHH signaling pathways to integrate both patterning dimensions into Nkx2.2+ progenitor identity. This finding builds on what is known about RA and SHH signals for Olig2+ progenitor development in the spinal cord (53, 54).

Additionally, the 3D context of this screening platform enables high-throughput investigation into neurodevelopmental model systems that can offer unique perspectives beyond what is capable in 2D screening platforms, for example, by recapitulating cell-to-cell interactions, cytoskeletal arrangement, and multicellular patterning in 3D. The lumen structures that were observed during the neural induction period (fig. S2B and movie S1) in response to caudalizing conditions (high Wnt and RA) could be the basis of future organoid screening strategies to probe early multicellular arrangement and the effect of lumen size and shape on cell fate determination at various positions along the rostrocaudal and dorsoventral axes.

In conclusion, we demonstrate the versatile capabilities of a unique microculture platform for 3D differentiation screening and optimization of hPSC-derived cell therapies, whereby 1200 unique OPC differentiation timelines, and a total of over 4800 independent samples, were investigated using 0.2% of the reagent volumes required in a standard 96-well plate format. The dense dataset enabled subsequent statistical modeling for empirical optimization of the differentiation process and identified differential sensitivities to various culture parameters across time. These insights are important in developing strong process knowledge for manufacturing stem cell therapeutics as they continue to emerge in the clinic, and therefore, such screening strategies may accelerate the pace of discovery and development. Simultaneously, this combinatorial 3D hPSC differentiation screens may provide new insights on the basic biology of human development.

Human embryonic stem cells (H9s: National Institutes of Health Stem Cell Registry no. 0062) and hiPSCs (TCTFs: 8FLVY6C2, a gift from S. Li) were subcultured in monolayer format on a layer of 1% Matrigel and maintained in Essential 8 medium during expansion. At 80% confluency, H9s were passaged using Versene solution and replated at a 1:8 split.

H9s were dissociated into single cells using Accutase solution and resuspended in Essential 8 medium containing 10 M Y-27632 (ROCK Inhibitor). H9s were counted and resuspended at defined densities in 50% Matrigel solution on ice. While chilled, 100 nl of H9s in 50% Matrigel solution was deposited onto the micropillars at a density of 100 cells per pillar, unless otherwise noted, using a custom robotic liquid handling program and then incubated at 37C for 20 min to promote gelation of 3D cultures. The micropillar chip was then inverted and placed into a fresh microwell chip containing cell culture media (table S1). All liquid dispensing into the microculture platform was performed with a DIGILAB OmniGrid Micro liquid handler with customized programs for deposition patterns. Between days 2 and 0, cells were kept in E8 media supplemented with 10 M ROCK Inhibitor. Between days 0 and 10, cells were kept in differentiation media made of a base of 50% Dulbeccos Modified Eagles MediumF12, 50% Neurobasal, 0.5% penicillin/streptomycin (pen/strep), 1:100 GlutaMAX supplement, 1:50 B27 supplement, and 1:50 N2 supplement. Between days 10 and 21, cells were kept in differentiation media made of a base of 100% Neurobasal, 0.5% pen/strep, 1:100 GlutaMAX supplement, 1:50 B27 supplement, and 1:50 N2 supplement. After day 21, OPCs were transitioned to maturation media consisting of 100% Neurobasal, 0.5% pen/strep, 1:100 GlutaMAX supplement, 1:50 B27 supplement, 1:50 N2 supplement, insulin-like growth factor 1 (10 ng/ml), platelet-derived growth factor (PDGF)AA (10 ng/ml), NT-3 (10 ng/ml), and insulin (25 g/ml). Media were changed daily by transferring the micropillar chip into a microwell chip containing fresh media every other day using a custom-made mechanical Chip Swapper for consistent transfer. Technical replicates included two different dispensing patterns to average out positional effects across the microchip.

At the endpoint of the experiment, the micropillar chip was carefully removed from the microwell chip and placed in new microwell chip containing calcein AM, ethidium homodimer, and Hoechst diluted in sterile phosphate-buffered saline (PBS) (dilution details in table S1). The micropillar chip was incubated for 20 min and then transferred to a new microwell chip containing PBS, and individual microenvironments were imaged using fluorescence microscopy.

At the endpoint of the experiment, the micropillar chip was carefully removed from the wellchip and placed into a bath of 4% paraformaldehyde for 15 min to fix cell cultures. Then, the micropillar chip was washed twice in PBS for 5 min each and placed into a bath of 0.25% Triton X-100 + 5% donkey serum in PBS for 10 min to permeabilize cells. After permeabilization, the micropillar chip was washed five times in 5% donkey serum for 5 min each, transferred to a wellchip containing primary antibodies of interest diluted in PBS + donkey serum (dilution details in table S1), and stored overnight at 4C. After primary staining, the micropillar chip was washed twice in PBS for 5 min each, placed into a microwell chip containing the corresponding secondary antibodies (dilution details in table S1), and incubated at 37C for 2 hours. After secondary staining, the micropillar chip was washed twice in PBS for 5 min each and placed into a wellchip containing PBS; individual microenvironments were imaged using fluorescence confocal microscopy.

Stained micropillar chips were sealed with a polypropylene film (GeneMate T-2452-1) and imaged with a 20 objective using a Perkin Elmer Opera Phenix automated confocal fluorescence microscope available in the High-Throughput Screening Facility at University of California, Berkeley. Laser exposure time and power were kept constant for a fluorescence channel within an imaging set. Images were scored for marker expression depending on nuclear or cytoplasmic localization (fig. S3).

Fixed cultures on micropillars at day 15 were stained with 4,6-diamidino-2-phenylindole (DAPI) and imaged using an upright Olympus BX51WI microscope (Olympus Corporation) equipped with swept field confocal technology (Bruker) and a Ti:sapphire two-photon Chameleon Ultra II laser (Coherent) was used. The two-photon laser was set to 405 nm, and images were captured using an electron multiplying charge-coupled device camera (Photometrics). Prairie View Software (v. 5.3 U3, Bruker) was used to acquire images, and ImageJ software was used to create a video of the z-series.

Quantified image data were then imported into Python for statistical data analysis (55) and visualization. For comparisons between datasets acquired across different experimental sessions, raw data were scaled and centered by z score, and descriptive statistics were calculated from four technical replicates. Error bars represent 95% confidence intervals, unless otherwise specified. For the hierarchical cluster model, the Euclidean distance was used to measure pairwise distance between each observation, and the unweighted pair group method with arithmetic mean (UPGMA) algorithm was used to calculate the linkage pattern. A Benjamini and Hochberg false discovery rate correction was applied as needed to correct for multiple comparisons. Code is available upon request.

Acknowledgments: We thank M. West of the High-Throughput Screening Facility (HTSF) at UC Berkeley and E. Granlund of the College of Chemistry machine shop for machining custom parts. In addition, we are grateful to G. Rodrigues, M. Adil, and J. Zimmermann for participating in the discussions on the work. Funding: This research was supported by the California Institute for Regenerative Medicine (DISC-08982) and the NIH (R01-ES020903) and Instrumentation Grant (S10OD021828) that provided the Perkin Elmer Opera Phenix microscope. R.M. was supported in part by an NSF Graduate Research Fellowship. Author contributions: R.M., D.S.C., and D.V.S. conceived various parts of the project and supervised the study. R.M. designed the experiments and managed the project workflows. X.B. created Nkx2.2-Cre H9 reporter lines. R.M., E.T., and E.C. performed the experiments. R.M. conducted statistical modeling, and A.M. aided in statistical testing. R.M., D.S.C., and D.V.S. analyzed and interpreted the data. R.M. wrote the manuscript with revisions from J.S.D., D.S.C., and D.V.S. Competing interests: R.M., D.S.C., and D.V.S. are inventors on a U.S. patent pending related to this work filed by the University of California, Berkeley (PCT/US2020/029553, filed on 23 April 2020). D.V.S. is the inventor on two U.S. patent pendings related to this work filed by the University of California, Berkeley (PCT/US2016/055362, filed on 4 October 2016; no. PCT/US2016/055361, filed on 5 October 2015). All other authors declare that they have no competing interests. Data and materials availability: All data needed to evaluate the conclusions in the paper are present in the paper and/or the Supplementary Materials. Additional data related to this paper may be requested from the authors.

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High-throughput 3D screening for differentiation of hPSC-derived cell therapy candidates - Science Advances

Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth – GlobeNewswire

Houston, Texas, Aug. 06, 2020 (GLOBE NEWSWIRE) --

Houston, Texas, August 6, 2020 Immatics N.V. (NASDAQ: IMTX; Immatics), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, today announced the extension of its cell therapy manufacturing collaboration with The University of Texas Health Science Center at Houston (UTHealth), in Houston, Texas. The continued collaboration grants Immatics access to UTHealths state-of-the-art cGMP manufacturing infrastructure at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, enabling continued production and supply of Immatics specialized, cell-based product candidates for testing in multiple clinical trials. Maximum capacity of the facility is anticipated at 48 ACTengine T cell products per month. The new agreement will run until the end of 2024. Under the agreement, UTHealth will provide Immatics with exclusive access to three cGMP suites and support areas for the manufacturing of various Adoptive Cell Therapy (ACT) products. Therapeutic T cell production will be carried out by Immatics manufacturing personnel and will be supported by a UTHealth-Immatics joint quality team.

Steffen Walter, Ph.D., Chief Technology Officer at Immatics, commented: During the last five years, we have established a strong and productive partnership with UTHealth that has enabled the initiation of four ongoing clinical trials. As we remain focused on the development of our clinical pipeline, this extension of our collaboration with UTHealth will fulfill Immatics manufacturing needs for our early-stage ACT clinical programs for the next four years. Being able to rely on a partner with profound cell therapy expertise who is familiar with our technologies and can support cGMP cell therapy production is critical to ensuring the advancement of our clinical trials. We look forward to continuing this fruitful collaboration with the experts at UTHealth.

Fabio Triolo, D.d.R., M.Phil., Ph.D., The Clare A. Glassell Distinguished Chair and Director of the Cellular Therapy Core at UTHealth, added: Signing the extended contract with Immatics fits into our strategy at UTHealth of supporting the development of new treatments for patients in need. We therefore look forward to continuing our collaboration and further leveraging the potential of our manufacturing capabilities.

About Immatics ACT ProgramsACTengine is a personalized approach in which the patients own T cells are genetically modified to express a novel proprietary TCR cognate to one of Immatics proprietary cancer targets which are then reinfused back into the patient. Immatics latest proprietary ACTengine manufacturing processes are designed to generate cell product candidates within a short six day manufacturing window and to deliver highly proliferative T cells, with the capability to infiltrate the patients tumor and function in a challenging solid tumor microenvironment. The process is designed to rapidly produce younger, better-persisting T cells capable of serial killing tumor cells in vitro. Immatics is further advancing the ACT concept beyond individualized manufacturing with its product class ACTallo which is being developed to generate off-the-shelf cellular therapies.

More information on the clinical trials can be found at the following links: https://immatics.com/clinical-programs/ and https://clinicaltrials.gov/.

- ENDS -Notes to Editors

About ImmaticsImmatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.

For regular updates about Immatics, visit http://www.immatics.com. You can also follow us on Twitter and LinkedIn.

About UTHealthEstablished in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houstons Health University and Texas resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in the UT System and the U.S. Gulf Coast region, UTHealth is home to Jane and Robert Cizik School of Nursing, John P. and Kathrine G. McGovern Medical School and schools of biomedical informatics, biomedical sciences, dentistry and public health. UTHealth includes The University of Texas Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UT Dentists and UT Health Services. The universitys primary teaching hospitals are Memorial Hermann-Texas Medical Center, Childrens Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital. For more information, visit http://www.uth.edu.

About the Evelyn H. Griffin Stem Cell Therapeutics Research LaboratoryThe Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, which is part of the Cellular Therapy Core at UTHealth, has been Immatics manufacturing partner since 2015. The site is a U.S. Food and Drug Administration (FDA)-registered and inspected cGMP facility that has received accreditation from the Foundation for Accreditation of Cellular Therapy (FACT) as well as certification from the Clinical Laboratory Improvement Amendment (CLIA) and the College of American Pathologists (CAP).

Forward-Looking StatementsCertain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as may, should, expect, intend, will, estimate, anticipate, believe, predict, potential or continue, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in filings with the Securities and Exchange Commission (SEC). Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements.

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Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth - GlobeNewswire

Contract Manufacturing Services market for stem cells is expected to be worth over USD 2.5 billion by 2030, claims Roots Analysis – Market Research…

Driven by a robust and growing pipeline of stem cell therapies, the demand for development and manufacturing services for such advanced product candidates is anticipated to increase beyond the capabilities of innovator companies alone

Roots Analysis has announced the addition of the Stem Cell Contract Manufacturing Market, 2019-2030 report to its list of offerings.

Owing to a highly regulated production environment and the need for state-of-the-art technologies and equipment, it is difficult for innovators to establish in-house expertise for the large-scale manufacturing of stem cell therapies. As a result, stem cell therapy developers are increasingly relying on contract manufacturing organizations (CMOs) for their product development and manufacturing needs.

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Over 80 CMOs presently claim to provide manufacturing services for stem cells therapiesThe market landscape is fragmented, featuring a mix of companies of all sizes; however, small and mid-sized companies represent 70% of the overall number of industry stakeholders. It is worth highlighting that over 50% of the CMOs claim to be capable of accommodating both clinical and commercial scales of operation.

100+ strategic alliances have been inked since 2015In fact, nearly 60% of the abovementioned deals were established post 2016. Majority of these agreements were observed to be focused on the manufacturing of various types of stem cells. It is worth highlighting that the maximum number of partnerships related to stem cell therapies were reported in 2018.

More than 80,000+ patients were reported to have been enrolled in stem cell therapy related trials, since 2010As a result, the manufacturing demand for such therapies can be anticipated to grow significantly over the next decade. The report features detailed projections of the future clinical and commercial demand for stem cell manufacturing, based on parameters, such as target patient population, dosing frequency, dose strength, source of stem cells, type of stem cells and key geographies.

Currently, there are more than 100 facilities dedicated to stem cell manufacturingThe maximum share of the installed capacity belongs to large (more than 1,000 employees) and very large (more than 5,000 employees) companies. The report provides a detailed capacity analysis, taking into consideration the reported manufacturing capacities of industry stakeholders, and offering estimates on the distribution of the global contract manufacturing capacity for stem cell therapies, by company size, scale of operation and geography.

By 2030, North America and Europe are anticipated to capture over 70% of the market shareOverall, the market is anticipated to witness an annualized growth rate of more than 20% over the next decade. In the long-term, the opportunity is expected to be well distributed across key stakeholder companies, which offer services for a diverse range of allogenic and autologous stem cell therapies.

To request a sample copy / brochure of this report, please visit this link

The USD 2.5 billion (by 2030) financial opportunity within the stem cells contract manufacturing market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom the contract manufacturing opportunity related to stem cell therapies can be expected to witness substantial growth due to the rising demand for regenerative medicine across a number of therapeutic areas. The report includes detailed transcripts of discussions held with the following experts:

The research covers detailed profiles of key players (illustrative list provided below) from across key global markets (North America, Europe and Asia-Pacific); each profile provides an overview of the company, information on its service portfolio, manufacturing facilities, financial performance (if available), details on recent developments, as well as an informed future outlook.

For additional details, please visit https://www.rootsanalysis.com/reports/view_document/stem-cell-therapy-contract-manufacturing-market-2019-2030/271.html

or email [emailprotected]

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Contact:Gaurav Chaudhary+1 (415) 800 3415+44 (122) 391 1091[emailprotected]

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Contract Manufacturing Services market for stem cells is expected to be worth over USD 2.5 billion by 2030, claims Roots Analysis - Market Research...

In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Cancer Stem Cell Market Report 2020 Key Players Thermo Fisher Scientific Inc.,…

Rising number of corona virus cases has impacted numerous lives and led to numerous fatalities, and has affected the overall economic structure globally. The Cancer Stem Cell has analyzed and published the latest report on the global Cancer Stem Cell market. Change in the market has affected the global platform. Along with the Cancer Stem Cell market, numerous other markets are also facing similar situations. This has led to the downfall of numerous businesses, because of the widespread increase of the number of cases across the globe.href=mailto:nicolas.shaw@cognitivemarketresearch.com>nicolas.shaw@cognitivemarketresearch.com or call us on +1-312-376-8303.

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The major players in the Cancer Stem Cell market are Thermo Fisher Scientific Inc., AbbVie Inc., Merck KGaA, Bionomics, Lonza, Stemline Therapeutics Inc., Miltenyi Biotec, PromoCell GmbH, MacroGenics Inc., OncoMed Pharmaceuticals Inc., Irvine Scientific, STEMCELL Technologies Inc., Sino Biological Inc., BIOTIME Inc. . Some of the players have adopted new strategies to sustain their position in the Cancer Stem Cell market. A detailed research study is done on the each of the segments, and is provided in Cancer Stem Cell market report. Based on the performance of the Cancer Stem Cell market in various regions, a detailed study of the Cancer Stem Cell market is also analyzed and covered in the study.

Report Scope:Some of the key types analyzed in this report are as follows: Cell Culturing, Cell Separation, Cell Analysis, Molecular Analysis, Others

Some of the key applications as follow: Stem Cell Based Cancer Therapy, Targeted CSCs

Following are the major key players: Thermo Fisher Scientific Inc., AbbVie Inc., Merck KGaA, Bionomics, Lonza, Stemline Therapeutics Inc., Miltenyi Biotec, PromoCell GmbH, MacroGenics Inc., OncoMed Pharmaceuticals Inc., Irvine Scientific, STEMCELL Technologies Inc., Sino Biological Inc., BIOTIME Inc.

An in-depth analysis of the Cancer Stem Cell market is covered and included in the research study. The study covers an updated and a detailed analysis of the Cancer Stem Cell market. It also provides the statistical information of the Cancer Stem Cell market. The study of the report consists of the detailed definition of the market or the overview of the Cancer Stem Cell market. Furthermore, it also provides detailed information for the target audience dealing with or operating in this market is explained in the next section of the report.

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The report also provides detailed information on the research methodologies, which are used for the analysis of the Cancer Stem Cell market. The methods are covered in detail in this section of the report. For the analysis of the market, several tools are used for the extraction of the market numbers. Among the several tools, primary and secondary research studies were also incorporated for the research study. These were further analyzed and validated by the market experts, to increase precision and make the data more reliable.

Moreover, the report also highlights and provides a detailed analysis of the drivers, restrains, opportunities, and challenges of the Cancer Stem Cell market. This section of Cancer Stem Cell market also covers the updated information, in accordance with the present situation of the market.

According to the estimation and the analysis of the market, the Cancer Stem Cell market is likely to have some major changes in the estimated forecasts period. Moreover, these changes can be attributed to the changes due to economic and trading conditions across the globe. Moreover, several market players operating in the Cancer Stem Cell market will have to strategically change their business strategies in order to survive in the market.

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Reasons for Buying this Cancer Stem Cell Report1. Cancer Stem Cell market advertise report helps with understanding the Basic product segments alongside likewise their potential future.2. This global Cancer Stem Cell report offers pin-point evaluation for changing competitive dynamics.3. The Cancer Stem Cell market supplies pin point analysis of changing competition dynamics and keeps you in front of competitors4. Original images and illustrated a SWOT evaluation of large segments supplied by the Cancer Stem Cell market.5. This report supplies a forward-looking perspective on different driving factors or controlling Cancer Stem Cell market gain.6. This report assists to make wise business choices using whole insights of the Cancer Stem Cell and also from creating a comprehensive evaluation of market sections.Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

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In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Cancer Stem Cell Market Report 2020 Key Players Thermo Fisher Scientific Inc.,...

Tafasitamab Combination Approved for Adults With R/R DLBCL – AJMC.com Managed Markets Network

On July 31, FDA approved tafasitamab-cxix to be used in combination with lenalidomide for second-line treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), meeting the needs of patients who are not eligible for an autologous stem cell transplant.

Tafasitamab, to be sold as Monjuvi by MorphoSys and Incyte, is a humanized Fc-modified cytolytic CD19 monoclonal antibody being studied in several B-cell malignancies. As described in the journal Blood, the treatment uses Xencors proprietary Xmab technology, which deploys a different technique to boost affinity for the antigen and make various receptors especially capable of binding to it. In 2018, authors in Annals of Oncology described how this sets off particularly effective processes that target cancer cells and regulate cell death.

Approval was based on phase 2 results for 80 patients in the L-MIND trial, which reported an update May 2019 at the American Society of Clinical Oncology, with final results published last month in The Lancet. Results submitted to FDA showed an overall response rate of 55%, including a compete response rate of 37% and a partial response rate of 18%. Median duration of response was 21.7 months. Common adverse events included neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

Among non-Hodgkin lymphomas, DLBCL is the most common subtype, accounting for 22% of cases in the United States and 40% worldwide, with about 18,000 US cases per year. People are at higher risk if they have HIV, an autoimmune disease, or if they have had an organ transplant. More common in older people, DLBCL can be very aggressive. Although well-known treatments have been developed, there are gapsand a notable one is when DLBCL cannot be kept in remission after chemotherapy but the patient is not eligible for an autologous stem cell transplant. Some of these patients have had chimeric antigen receptor (CAR) T-cell therapy, but this process is costly with significant side effects.

The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States, Herv Hoppenot, CEO of Incyte, said in a statement. At Incyte we are committed to advancing patient care and are proud to bring this new and much-needed targeted therapeutic option to appropriate patients and the clinical community.

FDA had previously granted the combination Fast Track and Breakthrough Therapy Designation in this indication.

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Tafasitamab Combination Approved for Adults With R/R DLBCL - AJMC.com Managed Markets Network