ROCKVILLE, Md., May 26, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC) and Myriad Genetics Inc. (NASDAQ: MYGN) today announced that levels of novel cytokine, LIGHT, were highly correlated with disease severity and mortality in a COVID-19 acute respiratory distress syndrome (ARDS) biomarker study. The biomarker study was conducted using the serum samples of 47 hospitalized COVID-19 patients and 30 healthy controls from Hackensack Meridian Health Network.

In April 2020, approximately 1,500 people in the United States died each day from COVID-19. The viral infection triggers a hyperactive immune response leading to cytokine storm and Acute Respiratory Distress Syndrome (ARDS), which is a leading cause of death in patients who die of COVID-19. Although this hyperinflammatory process is poorly understood, the data from this study implicates the inflammatory cytokine, LIGHT, as a potential key driver of cytokine storm leading to ARDS and death.

LIGHT levels were significantly elevated in the serum of hospitalized patients with COVID-19 versus healthy controls (p value < 0.0001). The highest LIGHT levels were found in patients who required ventilator support, particularly in patients over 60. Importantly, the data demonstrated elevated LIGHT levels were also strongly linked with mortality (p=0.02).

Dr. David Perlin, Ph.D., chief scientific officer, senior vice president of the Center for Discovery and Innovation, and Professor of Medical Sciences at the Hackensack Meridian School of Medicine at Seton Hall University, commented These data are compelling and demonstrate that the inflammatory cytokine LIGHT may play a key role in cytokine storm associated with COVID-19 ARDS that leads to increased morbidity and mortality. Reducing LIGHT levels might be a key to dampening the cytokine storm in these patients, preventing the need for ventilator support and reducing mortality.

Dr. Garry Neil, M.D. chief scientific officer, Cerecor commented, As a company, we recognized the impact of cytokine storm-induced ARDS and the need for treatment options for patients in this area of high unmet need. We remain focused on the CERC-002 clinical program and rapidly moving it forward for the treatment of cytokine storm induced ARDS.

Role of LIGHT in Acute Inflammatory Response

LIGHT (homologous to Lymphotoxin, exhibits inducible expression and competes with HSV glycoprotein D for binding to herpesvirus entry mediator, a receptor expressed on T lymphocytes) is a cytokine with inflammatory actions encoded by the TNFSF14 gene. LIGHT has been shown to play a key role in the immune response to viral pneumonia. LIGHT plays an important role in regulating immune responses in the lung, gut and skin. It stimulates T Cell and B Cell response as well as induces the release of other cytokines such as IL1, IL6, IL-8, IL-10, TNF and GM-CSF.

CERC-002 (anti-LIGHT monoclonal antibody)

CERC-002 is a fully human monoclonal antibody with neutralizing action against LIGHT (TNFSF14), for treatment of children with Pediatric Crohns Disease. Cerecor holds an open IND with FDA and the drug is currently being studied in a Phase I clinical trial for patients with refractory severe Crohns disease, currently not recruiting due to COVID-19.

Free LIGHT Assay from Myriad RBM

Myriad RBM, a subsidiary of Myriad Genetics, Inc., in collaboration with Cerecor has developed an ultrasensitive assay for the detection of free LIGHT. The assay is validated for serum or plasma samples and has sufficient sensitivity to reliably measure LIGHT from normal and disease subjects.

About Myriad

Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

About Hackensack Meridian Health

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children's hospitals - Joseph M. Sanzari Children's Hospital in Hackensack, K. Hovnanian Children's Hospital in Neptune; nine community hospitals Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital Carrier Clinic in Belle Mead; and two rehabilitation hospitals JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick. Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 34,100 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

About the Center for Discovery and Innovation

The Center for Discovery and Innovation (CDI), a newly established member of Hackensack Meridian Health, seeks to translate current innovations in science to improve clinical outcomes for patients with cancer, infectious diseases and other life-threatening and disabling conditions. The CDI, housed in a fully renovated state-of-the-art facility, offers world-class researchers a support infrastructure and culture of discovery that promotes science innovation and rapid translation to the clinic.

About Cerecor

Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies. The Companys pediatric rare disease pipeline is led by CERC-801, CERC-802 and CERC-803 (CERC-800 programs), which are therapies for inborn errors of metabolism, specifically disorders known as Congenital Disorders of Glycosylation (CDGs). The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation (ODD) to all three CERC-800 programs, thus potentially qualifying the Company to receive a Priority Review Voucher (PRV) upon approval of a new drug application (NDA). The Company is also developing CERC-002, CERC-006 and CERC-007. CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as Adult Onset Stills Disease (AOSD) and Multiple Myeloma (MM). CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex Lymphatic Malformations. CERC-002 is an anti-LIGHT monoclonal antibody being developed for the treatment of Pediatric-onset Crohns Disease.

For more information about Cerecor, please visit http://www.cerecor.com.

Forward-Looking Statements

This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecors control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecors plans, objectives, projections, expectations and intentions and other statements identified by words such as projects, may, might, will, could, would, should, continue, seeks, aims, predicts, believes, expects, anticipates, estimates, intends, plans, potential, or similar expressions (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecors management but are subject to significant risks and uncertainties, including: drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; regulatory risks; Cerecor's cash position and the need for it to raise additional capital; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic; and those other risks detailed in Cerecors filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecors expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For media and investor inquiries for Cerecor, Inc.

James Harrell,Investor RelationsChief Commercial OfficerCerecor Inc.jharrell@cerecor.com623.439.2220 office

For media and investor inquiries for Myriad Genetics, Inc.

Scott GleasonSVP of Investor Relations and Corporate StrategyMyriad Genetics, Inc.sgleason@myriad.com801.584.1143 office

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Cerecor and Myriad Genetics Announce that Levels of LIGHT, a Novel Cytokine, Were Highly Correlated with Disease Severity and Mortality in COVID-19...

SAN DIEGO--(BUSINESS WIRE)--Progenity, a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced the appointment of Damon Silvestry as Chief Operating Officer (COO). With over 15 years of strategic lab and business operations experience, Mr. Silvestry will oversee key business functions with the goal of delivering operational excellence, coordinating product teams to achieve ambitious growth targets, and driving the companys service culture.

Damon strengthens the Progenity executive team with an established track record as a results-driven leader capable of influencing excellence in people, process, and products while sustaining focus on cost, efficiency, margin improvement, compliance, and a positive payor/customer experience, said Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity. We are focused on accelerating growth and creating an outstanding user experience within our diagnostic offerings and therapeutic precision medicine platforms. Damons experience in leading organizations, scaling similar businesses whilst improving payor and customer service standards, will enable us to achieve our goal of delivering a robust pipeline of digital health solutions based on transformative innovation.

Mr. Silvestry combines a deep understanding of the genetic testing landscape with experience managing organizational change in high-growth life science and technology companies, including roles with Natera, Miraca Life Sciences, and Dell. Most recently, Mr. Silvestry served as Senior Vice President, Operations and People Office at Natera, where he led a team of more than 350 members to deliver both genetic testing and liquid biopsy services to enable earlier detection of cancer and determine optimal treatments.

Its imperative that Progenity is positioned to successfully drive improvement of patient outcomes in prenatal and perinatal medicine, oncology, and gastroenterology, said Mr. Silvestry. I look forward to leading Progenitys operations and client services teams through continual improvement of operational excellence.

About Progenity

Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenitys vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit http://www.progenity.com.

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Progenity Adds Operational Expertise to Leadership Team with Appointment of Damon Silvestry as COO - Business Wire

Naptime is over.

Ilhem Messaoudi Powers, associate professor of molecular biology & biochemistry at UCI, is enjoying a rare weekend at home with her husband, Dr. Michael Powers, when they hear the rustling of their two young children.

He bounds up the stairs to retrieve Owen, 3, and Olivia, 6 months, from a Saturday afternoon slumber. Soon the living room is full of the joyous noises of a toddler and an infant.

When theyre not wearing their mommy and daddy hats, Ilhem and Michael Powers are exploring and immersing themselves in an entirely different world: the COVID-19 pandemic.

A virologist and immunologist, Ilhem Powers leads a team of researchers whove launched a surveillance study of UCI Health workers to determine how many have antibodies against the coronavirus.

Michael Powers is a pulmonologist who works as a critical care doctor at the Naval Medical Center San Diego, caring for patients with COVID-19, as well as others.

Because of his unpredictable schedule, he often stays for days at an apartment in San Diego while his wife, with the assistance of a part-time nanny, juggles kids and career from the couples on-campus home and her laboratory.

Mike and I have been through a lot together, she says. Weve really learned to focus on the now.

Indeed, her husband was just two weeks into medical school at New Orleans Tulane University when Hurricane Katrina hit in late August of 2005. Ilhem Powers had accepted a job at the school as an assistant professor and was getting ready to relocate from their previous home in Portland, Oregon.

The New Orleans duplex that the couple had renovated with most of their savings wound up under 8 feet of water. It took them more than a year to recover.

One of the biggest lessons Ive learned in life is to focus on the things you have some control over, Michael Powers says. You just have to let go of the rest.

Surveillance study

Ilhem Powers lab cohort have pivoted from their usual work to conduct COVID-19 research as members of UCIs Institute for Immunology and Center for Virus Research.

Their surveillance study, funded by a $60,000 UCI grant and expected to last a year, will repeatedly examine 300 healthcare providers. The collection of samples has already begun.

We want to know how many of them may have already been exposed [to COVID-19] and didnt know about it and how many of them potentially have immunity, Ilhem Powers says. Well take blood samples and nose swabs to measure antibodies and T cell responses, which kill infected cells, as well as potential asymptomatic shedding. Its a multipronged approach.

Arriving at UCI in January 2017 after serving as a researcher and assistant professor at UC Riversides School of Medicine, she has years of experience studying how the human immune system interacts with emerging viral diseases such as Ebola, Chikungunya, Zika and monkeypox.

For some viruses, Ilhem Powers explains, antibodies are sufficient [to kill them]. For others, you need more of a T cell response. We dont yet know enough about this novel coronavirus.

More community surveillance needs to be done, she says: How many people have potential COVID-19 antibodies? We also need to look at the immune response in patients those currently in hospitals and then determine the difference between the immune response of those who end up in the ICU versus those who end up being sent home.

Health scare

Michael Powers, who began his residency at the Naval Medical Center San Diego in 2010, says the COVID-19 pandemic has forced him and other doctors to live with a lot of uncertainty.

But he has a stoic air about him despite his relatively new role of treating patients with a little-understood disease. Perhaps experiencing a serious lung-related health scare himself contributes to his even-keeled nature.

During his wifes last year at UC Riverside, Michael Powers went on an outreach mission to Ghana. Shortly after returning home, he developed MRSA in his lungs and had to undergo thoracic surgery. He spent 10 days in the hospital and 30 days in convalescence.

It was a pulmonologists worst nightmare, Ilhem Powers says. It was really scary.

So is COVID-19, her husband says: I think a lot of people have a very romanticized notion of what ICU-level care is and being on a ventilator. The movies definitely dont do it justice.

When people go on ventilators, its not at all uncommon for them to be on them for two weeks or more. Its not a pleasant thing to have a giant plastic tube down your throat and a machine telling you when to breathe.

Enjoying the little moments

Michael Powers says he takes extreme precautions at work and elsewhere in San Diego before driving up to Irvine to spend time with his wife and children.

People ask me all the time, Isnt he worried? Ilhem Powers says. They ask, Shouldnt he just stay in his apartment and not come up here and pose a health risk to you and your kids? And we just say we understand and accept the risk.

She and her colleagues get tested regularly for COVID-19 using equipment in their lab.

Having already weathered a lot of adversity, the couple believe theyre uniquely equipped to cope with COVID-19.

What we both do for a living, and our past experience dealing with crises, has put us in this perfect position to deal with this pandemic, he says.

For many people, she adds, this is the first time that things outside their control have completely dominated their life.

Often, the two will sit down and go over COVID-19 research papers together and compare notes, discussing where the pandemic is headed, possible therapies and longer term potential vaccines.

But they make sure that when theyre together, they shower most of their attention on Owen and Olivia.

When hes home, Ilhem Powers says of her husband, its family time. For us, its all about enjoying the little moments.

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Couple on the coronavirus front lines - UCI News

While in the UK the NHS kept tight control of testing until recently, the Portuguese government quickly realised spreading the load was the answer.

As recently as May 1 to 17, non-state labs were still responsible for more than half of the almost 14,000 tests being conducted daily.

But the roots of Portugals world-class Covid-19 testing regime began much earlier.According to Our World in Data whose testing rates have been cited by the OECD and others Portugal has been among the top 10 countries in the world for testing per capita since mid-April.

On Friday, Denmark (with a GDP per capita 2.7 times that of Portugal) and Lithuania (with a similar GDP per capita to Portugal) were the only nations of more than 2 million people with a higher testing rate.

Like most countries, Portugals initial testing efforts started slowly amid difficulties securing kits in a ferocious global market.

The stress initially was to provide testing, said biology professor Miguel Viveiros, deputy director of IMHT.

We were not prepared for testing in quantity for the speed of transmission. In early March, Portugal was testing less per capita than the UK and much of Europe.

Professor Maria Manuel Mota, director of the institute of molecular medicine at the University of Lisbon, was speaking to doctors at the large university hospital on campus. They were worried about having enough tests to make sure the disease wasnt spreading rapidly in the medical community, let alone for the wider population.

Obviously there will be no testing for everyone, they told her. It is a difficult test, it takes a few hours, you know, it's expensive.

Sitting at home on March 11, Professor Mota quickly discovered that didnt have to be the case, thanks to her institutes experience with PCR-based tests for malaria.

The test we do all the time in almost every single lab in our institute is PCR, so it should not be difficult, she remembered thinking. Instead of relying on expensive kits that come from abroad we could design something.

To lead the project, she called on researcher Vanessa Zuzarte Lus, who had a potential testing protocol in mind within a few hours. The next day they were speaking to a Portuguese company about manufacturing the reagents needed for the tests, one factor UK authorities blamed for testing difficulties.

They were ready and working within a week, leaving only accreditation from the Dr Ricardo Jorge National Institute of Health left to secure.

The Portuguese authorities were fantastic, Professor Mota said. As soon as I called the right people they told us okay, let's validate this together. The accreditation process ran smoothly and the tests were being rolled out to nursing homes by the end of March.

Within two or three weeks, university labs and private institutes across Portugal were using the protocol developed at IMM, or developing their own, to bolster public testing efforts.

In the UK, independent labs trying to take similar steps were still complaining their offers to help were being ignored as late as April 10, well after health secretary Matt Hancock set a target of 100,000 tests a day.

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Why Portugal's Covid-19 test rate is more than double almost every other nation - Telegraph.co.uk

Peng Gao,1,2 Shuo Shen,1,2 Xiaodong Li,3 Dandan Liu,1,2 Yuqing Meng,1,2 Yanqing Liu,1,2 Yongping Zhu,1,2 Junzhe Zhang,1,2 Piao Luo,1,2 Liwei Gu1,2

1Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, Peoples Republic of China; 2Artemisinin Research Center, China Academy of Chinese Medical Sciences, Beijing 100700, Peoples Republic of China; 3Institute of Chinese Materia Medica, Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou 730050, Peoples Republic of China

Correspondence: Liwei Gu Email lwgu@icmm.ac.cn

Background: Leukemia threatens so many lives around the world. Dihydroartemisinin (DHA), as a typical derivative of artemisinin (ART), can efficiently inhibit leukemia, but the controversial mechanisms are still controversial. Many reports showed that tumor cells acquire energy through the glycolysis pathway, pyruvate kinase M2 (PKM2) plays a crucial role in regulating glycolysis. However, it is unclear whether PKM2 or other key molecules are involved in DHA induced cytotoxicity in leukemia cells. Thus, this paper systematically investigated the anticancer effect and mechanism of DHA on human chronic myeloid leukemia K562 cells.Methods: In vitro, cytotoxicity was detected with CCK-8. Glucose uptake, lactate production and pyruvate kinase activity were investigated to evaluate the effect of DHA on K562 cells. To elucidate the cellular metabolism alterations induced by DHA, the extracellular acidification rate was assessed using Seahorse XF96 extracellular flux analyzer. Immunofluorescence, real-time PCR, and Western blotting were used to investigate the molecular mechanism.Results: We found that DHA prevented cell proliferation in K562 cells through inhibiting aerobic glycolysis. Lactate product and glucose uptake were inhibited after DHA treatment. Results showed that DHA modulates glucose uptake through downregulating glucose transporter 1 (GLUT1) in both gene and protein levels. The cytotoxicity of DHA on K562 cells was significantly reversed by PKM2 agonist DASA-58. Pyruvate kinase activity was significantly reduced after DHA treatment, decreased expression of PKM2 was confirmed in situ.Conclusion: The present study implicated that DHA inhibits leukemia cell proliferation by regulating glycolysis and metabolism, which mediated by downregulating PKM2 and GLUT1 expression. Our finding might enrich the artemisinins antitumor mechanisms.

Keywords: tumor, leukemia, glycolysis, DHA, PKM2, GLUT1

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Dihydroartemisinin Inhibits the Proliferation of Leukemia Cells K562 b | DDDT - Dove Medical Press

DetailsCategory: AntibodiesPublished on Wednesday, 27 May 2020 10:50Hits: 80

BASEL, Switzerland I May 27, 2020 I Novartis announced today that new ofatumumab data from the Phase III ASCLEPIOS trials and the Phase II APLIOS trial were presented virtually at the 6th Congress of the European Academy of Neurology (EAN). The data continue to demonstrate ofatumumab (OMB157) as a potential novel treatment option for patients with RMS. The safety profile was comparable to teriflunomide2.

Ofatumumab is a targeted B-cell therapy that, if approved, addresses a clinical unmet need as the first B-cell therapy that can be self-administered at home through an autoinjector pen2. In addition to being presented virtually, the data were also published in the European Journal of Neurology, Volume 27, Supplement 1, May 2020.

A post hoc analysis from the Phase III ASCLEPIOS I and II trials (n=1882) assessed the odds of patients achieving NEDA-3 with ofatumumab versus teriflunomide within the first (Month 012) and second year (Month 1224) of treatment1. NEDA-3 is a comprehensive composite measure commonly used to assess treatment outcomes in patients with RMS. It is defined as an absence of three measures of disease activity: relapses; disease progression, measured as 6-month confirmed disability worsening (CDW), and gadolinium enhancing (Gd+) T1 lesions3. The study results showed that compared with teriflunomide, a greater proportion of patients treated with ofatumumab achieved NEDA-3 in year 1 (47.0% vs 24.5%; P<.001) and in year 2 (87.8% vs 48.2%; P<.001)1.

Achieving no evidence of disease activity is widely recognized as an important treatment goal for multiple sclerosis therapies, said Professor Ludwig Kappos, University Hospital Basel. These data suggest that halting new disease activity is possible by targeted B-cell therapy in RMS.

A separate analysis from the APLIOS trial (n=284) showed ofatumumab treatment led to rapid and sustained depletion of both CD20+B- and T-cells in patients with RMS. Ofatumumab depleted different B- and T-cell subsets including memory B-cells and nave B-cells, as well as a subset of T-cells that are known to exhibit an activated phenotype. However, CD3+T-cells that do not express the CD20 receptor, were largely unaffected4.

These results are encouraging and support our belief that, if approved, ofatumumab could have the potential to significantly improve the lives of people with RMS, said Krishnan Ramanathan, Neuroscience Global Program Head at Novartis. These data are a testament to our commitment to reimagining medicine and advancing innovative treatments that help people with this serious and progressive disease.

Regulatory action for ofatumumab in the US is expected in June 2020. Novartis is committed to bringing ofatumumab to patients around the world, and additional regulatory filings are currently under way.

About ofatumumabOfatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-adminstered by a once-monthly injection, delivered subcutaneously2,5. As shown in preclinical studies, ofatumumab is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion6. The selective mechanism of action and subcutaneous administration of ofatumumab allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and may preserve the B-cells in the spleen, as shown in preclinical studies7. Once-monthly dosing of ofatumumab also allows fast repletion of B-cells and offers more flexibility8. Ofatumumab was originated by Genmab and licensed to GlaxoSmithKline; Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 20159.

About ASCLEPIOS I and II studiesThe ASCLEPIOS I and II studies are twin, identical design, flexible duration (up to 30 months), double-blind, randomized, multi-center Phase III studies evaluating the safety and efficacy of ofatumumab 20 mg monthly subcutaneous injections versus teriflunomide 14 mg oral tablets taken once daily in adults with RMS. The ASCLEPIOS I and II studies enrolled 1882 patients with MS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.52. The studies were conducted in over 350 sites in 37 countries10. Ofatumumab demonstrated a significant reduction in annualized relapse rate (ARR) by 50.5% (0.11 vs 0.22) and 58.5% (0.10 vs 0.25) compared with teriflunomide (P<.001 in both studies) in ASCLEPIOS I and II respectively (primary endpoint). Ofatumumab showed significant reduction of both Gd+T1 lesions and new or enlarging T2 lesions. It significantly reduced the mean number of both Gd+T1 lesions (97.5% and 93.8% relative reduction in ASCLEPIOS I and II, respectively, both P<.001) and new or enlarging T2 lesions (82.0% and 84.5% relative reduction in ASCLEPIOS I and II, respectively, (both P<.001).

Ofatumumab also showed a relative risk reduction of 34.4% (P=.002) in 3-month CDW and 32.5% (P=.012) in 6-month CDW compared with teriflunomide in pre-specified meta-analysis, as defined in ASCLEPIOS. Ofatumumab demonstrated that it lowered neurofilament light levels in serum at the first assessment at Month 3 compared with teriflunomide. There was no difference in slope of brain volume change from baseline between treatments. In a measure of 6-month confirmed disability improvement events, a favorable trend was seen but this did not reach significance. The frequency of serious infections and malignancies was similar across both treatment groups, and overall, ofatumumab had a similar safety profile to teriflunomide. Injection-related reactions, injection-site reactions and upper respiratory tract infection were the most commonly observed adverse events across both treatment groups, occurring in 10% of patients2.

A separate post hoc analysis demonstrated ofatumumab may halt new disease activityin RMS patients. It showed the odds of achieving NEDA-3 (no relapses, no MRI lesions, and no disability worsening combined) with ofatumumab versus teriflunomide were >3-fold higher at Month (M) 012 (47.0% vs 24.5% of patients; P<.001) and >8-fold higher at M1224 (87.8% vs 48.2% of patients; P<.001)1. Overall ofatumumab, a fully human antibody targeting CD20+ B-cells, delivered superior efficacy and demonstrated a safety and tolerability profile with infection rates similar to teriflunomide2.

About APLIOS studyThe APLIOS study is a 12-week, open-label, Phase II bioequivalence study to determine the onset of B-cell depletion with ofatumumab subcutaneous monthly injections and the bioequivalence of subcutaneous administration of ofatumumab via a pre-filled syringeas used in ASCLEPIOS I and IIand an autoinjector pen in patients with RMS. Patients were randomized according to injection device and site including the abdomen and the thigh. B-cell depletion was measured nine times over 12 weeks and Gd+ lesion counts were assessed at baseline and at Weeks 4, 8 and 12. Regardless of injection device or site, ofatumumab 20 mg subcutaneous monthly injections resulted in rapid, close to complete and sustained B-cell depletion. The proportion of patients with B-cell concentrations of <10 cells/L was >65% after the first injection by Day 7, 94% by Week 4 and sustained >95% at all following injections. Ofatumumab treatment reduced the mean number of Gd+lesions from baseline (1.5) to 0.8, 0.3 and 0.1 by Weeks 4, 8 and 12, respectively. The proportion of patients free from Gd+ lesions at the corresponding time points were 66.5%, 86.7%, and 94.1%, respectively4,5.

About Multiple Sclerosis MS disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss11. MS, which affects approximately 2.3 million people worldwide12, is often characterized into three forms: primary progressive MS (PPMS)13, relapsing remitting MS (RRMS), and secondary progressive MS (SPMS), which follows from an initial RRMS course and is characterized by physical and cognitive changes over time, in presence or absence of relapses, leading to a progressive accumulation of neurological disability14. Approximately 85% of patients initially present with relapsing forms of MS12.

Novartis in NeuroscienceNovartis has a strong ongoing commitment to neuroscience and to bringing innovative treatments to patients suffering from neurological conditions where there is a high unmet need. We are committed to supporting patients and physicians in multiple disease areas, including MS, migraine, Alzheimer's disease, Parkinson's disease, epilepsy and attention deficit hyperactivity disorder, and have a promising pipeline in MS, Alzheimer's disease, spinal muscular atrophy and specialty neurology.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more athttps://www.novartis.com.

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References1. Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: Analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. Eur J Neurol. 2020;27(1):261263.2. Hauser S. Efficacy and safety of ofatumumab versus teriflunomide in relapsing multiple sclerosis: results of the phase 3 ASCLEPIOS I and II trials. Presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Conference; September 1113, 2019; Stockholm, Sweden.3. MS Trust. NEDA (no evidence of disease activity) [online]. Available from: https://www.mstrust.org.uk/a-z/neda-no-evidence-disease-activity [Last accessed: May 2020].4. Wiendl H, Fox E, Goodyear A, et al. Effect of Subcutaneous Ofatumumab on Lymphocyte Subsets in Patients with RMS: Analysis from the APLIOS Study. Eur J Neurol. 2020;27(1).5. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell Depletion with Subcutaneous Administration of Ofatumumab in Relapsing Multiple Sclerosis: Results from the APLIOS Bioequivalence Study. Presented at Americas Committee for Treatment and Research in Multiple Sclerosis Forum; February 2729, 2020.6. Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. Poster presented at ECTRIMS; September 2016; London, UK.7. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presented at ECTRIMS; September 1417, 2016; London, UK.8. Savelieva M, Kahn J, Bagger M, et al. Comparison of the B-Cell Recovery Time Following Discontinuation of Anti-CD20 Therapies. ePoster presented at ECTRIMS; October 2528, 2017; Paris, France.9. GSK press release. GSK completes divestment of rights to ofatumumab for auto-immune indications to Novartis. December 21, 2015. Available from: https://www.gsk.com/en-gb/media/press-releases/gsk-completes-divestment-of-rights-to-ofatumumab-for-auto-immune-indications-to-novartis/ [Last accessed: May 2020].10. Kappos L, Bar-Or A, Comi G, et al. Ofatumumab Versus Teriflunomide in Relapsing Multiple Sclerosis: Baseline Characteristics of Two Pivotal Phase 3 Trials (ASCLEPIOS I and ASCLEPIOS II). Poster presented at ECTRIMS; October 1012, 2018; Berlin, Germany.11. National Multiple Sclerosis Society. Definition of MS. Available from: https://www.nationalmssociety.org/What-is-MS/Definition-of-MS [Last accessed: May 2020].12. Multiple Sclerosis International Federation. Atlas of MS 2013. Mapping Multiple Sclerosis Around the World. Available from: http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf [Last accessed: May 2020].13. MS Society. Types of MS. Available from: https://www.mssociety.org.uk/about-ms/types-of-ms [Last accessed: May 2020].14. National Multiple Sclerosis Society. Secondary Progressive MS (SPMS). Available from: https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Secondary-progressive-MS [Last accessed: May 2020].

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Novartis announces new late-breaking ofatumumab data at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple...

Nine Harvard University scientists have been elected by their peers to the National Academy of Sciences (NAS) in recognition of their distinguished and continuing achievements in original research.

The society, together with the National Academy and the National Academy of Medicine, provides science, engineering, and health policy advice to the federal government and other organizations.

NAS is a private, nonprofit institution that recognizes achievement in science by election to its membership. Established under a congressional charter signed by President Abraham Lincoln in 1863, it now counts 2,347 voting members and 487 foreign associates among its members.

The nine Harvard faculty, including five from the Medical School, are among 120 members and 26 international members recognized this year. They are:

Dennis Gaitsgory, Herschel Smith Professor of Mathematics in the Faculty of Arts and Sciences (FAS).

Joel Habener, professor of medicine and chief of the Laboratory of Molecular Endocrinology at Massachusetts General Hospital.

Michael Kremer, Gates Professor of Developing Societies in the Department of Economics.

Judy Lieberman, professor of pediatrics and chair of Cellular and Molecular Medicine at Boston Childrens Hospital.

Kerstin Lindblad-Toh, scientific director of Vertebrate Genome Biology at the Broad Institute, professor in comparative genomics and director of Science for Life at Uppsala University.

Margaret Livingstone, the Takeda Professor of Neurobiology in the Blavatnik Institute at Harvard Medical School (HMS).

Olivier Pourqui, the Frank Burr Mallory Professor of Pathology at Brigham and Womens Hospital and professor of genetics in the Blavatnik Institute at HMS.

Wilfried Schmid, professor emeritus from the Department of Mathematics in the FAS.

Suzanne Walker, professor of microbiology in the Blavatnik Institute at HMS.

You can read more about Gaitsgory and Schmid in a story from the mathematics department and Habener, Lieberman, Livingstone, Pourqui, and Walker in a story on the HMS website.

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Nine Harvard faculty elected to National Academy of Sciences - Harvard Gazette

The FBI claims Dr. Qing Wang received more than $3.6 million in grants from the NIH while also collecting money for the same research from the Chinese government. Jose Luis Magana/AP hide caption

The FBI claims Dr. Qing Wang received more than $3.6 million in grants from the NIH while also collecting money for the same research from the Chinese government.

A former Cleveland Clinic Foundation doctor was arrested Wednesday and appeared in court on Thursday on charges of wire fraud and making false claims to obtain millions in federal grant funding.

It is the latest move in a federal crackdown on alleged participants in China's Thousand Talents Plan. The government believes the program may recruit U.S.-based scientists and researchers to steal intellectual property and scientific advances paid for with American funding.

The FBI claims Qing Wang, a U.S. citizen born in China, lied to receive more than $3.6 million in grants from the National Institutes of Health while also collecting money for the same research from the Chinese government.

"This is not a case of simple omission," FBI Cleveland Special Agent in Charge Eric Smith said in a statement.

Wang knowingly withheld information that he was employed and served as Dean of the College of Life Sciences and Technology at the Huazhong University of Science and Technology, according to Smith.

"Dr. Wang deliberately failed to disclose his Chinese grants and foreign positions and even engaged in a pervasive pattern of fraud to avoid criminal culpability," Smith said.

Had he revealed the connection, the FBI and Department of Justice say the doctor and his research group at the clinic would have been denied the NIH grants.

Officials at the Cleveland Clinic said Wang was fired after his ties to China were uncovered.

"Cleveland Clinic has cooperated fully with the NIH and with federal law enforcement as they conducted their own investigations into these same subjects and will continue to do so," it said in a statement.

Wang's work is dedicated to molecular medicine and the genetics of cardiovascular and neurological diseases.

As a result of his alleged participation in the Thousand Talents Plan, the Justice Department asserts Wang received $3 million in research support to improve operations at Huazhong University. In addition to a salary, he allegedly benefited from "free travel and lodging for his trips to China, to include a three-bedroom apartment on campus for his personal use."

The question of whether or not Wang and other academics are serving as spies for the Chinese government is one of the issues at the heart of President Trump's trade war with China.

The doctor's arrest comes just days after Dr. Xiao-Jiang Li, a former Emory University professor, pleaded guilty and was sentenced for failing to report foreign income from Chinese universities on his tax returns. Li is also accused of participating in the TTP.

The same day, a professor from the University of Arkansas, Dr. Simon Saw-Teong Ang, was arrested on charges of wire fraud for allegedly failing to disclose his ties to the Chinese government despite being required to do so as a recipient of grant money from NASA.

Robert Wells, acting assistant director of the FBI's Counterintelligence Division, said the cases demonstrate "Chinese government-supported talent plans continue to encourage people, regardless of nationality, to commit crimes, such as fraud to obtain U.S. taxpayer-funded research."

"The FBI and our partners will continue to rigorously investigate these illegal activities to protect our government, educational, and research institutions," Wells added.

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Researcher Qing Wang Arrested, Allegedly Failed To Disclose China Ties - NPR

Exchange traded fund investors should start thinking of innovation as an asset class worthy of its own allocation in a diversified global portfolio.

In the recent webcast, Making the Case for Innovation: Rethinking Traditional Asset Allocation, Renato Leggi, Client Portfolio Manager, ARK Invest, explained that according to ARKs research, the global economy is undergoing the largest technological transformation in history, with notable developments in blockchain technology, genome sequencing, robotics, energy storage and artificial intelligence that could quickly change the way we interact with the world.

However, Leggi pointed out that the average investor may be under-allocated to these innovative growth opportunities. ARK estimates that over the next ten years, roughly 50% of the companies in the S&P 500 Index will be replaced.

The market easily can be distracted by short-term price movements, losing focus on the long-term effect of disruptive technologies. We believe there is a time arbitrage ARK can take advantage of. We seek opportunities that offer growth over 3-5 years that the market ignores or underestimates, Leggi said.

Leggi argued that ARK Invest tries to target the middle ground between private markets that have been crowded by innovation investors and public markets that have grown increasingly passive. Consequently, ARK believes innovative public companies with forward-looking growth are the most inefficiently priced part of the market.

Passive index-based strategies that typically follow a market capitalization-weighted methodology may miss the mark on innovation as they passively wait for these companies to grow bigger. Meanwhile, analysts may have trouble understanding the technology cost curve. This allows an opportunity for more specialized opportunities that ARK has taken upon to look through cross-sector disruptive innovation themes to capitalize on the convergence of research.

Disruptive innovation demands an open-source approach to gain a deeper understanding of the convergence and full market potential. ARK uses an Open Research Ecosystem that combines top-down and bottom-up research. It is designed to identify disruptive innovation early, allowing for an organized exchange of insights between the portfolio manager, director of research, analysts, and external sources, Leggi added.

The innovative investment theme also provides portfolio diversification benefits. According to ARK, there is a lower correlation between disruptive technologies than correlation between S&P sectors. The average correlation between S&P 500 sectors is 0.55. On the other hand, ARK has identified five major innovation platforms blockchain, energy storage, DNA sequencing, robotics, and artificial intelligence and 14 underlying transformative technologies, and the average correlation between the 14 technologies is 0.26.

These innovative investment ideas may also enhance an investors equity portfolio. For example, looking at 5-year data ended 2019, a standard portfolio of 60% U.S. stocks, 30% international developed and 10% emerging market produced an annualized return of 14.3% with a Sharpe Ratio of 0.67. In comparison, a portfolio with just 10% innovation, 9% emerging markets, 27% international developed, and 54% U.S> produced an annualized return of 16.4% and a Sharpe Ratio of 0.75.

Investing in converging innovations and industries offers the possibility to produce outsized absolute and risk-adjusted returns. ARK believes investors should seek to identify stocks poised to benefit from trends not yet fully recognized in the market, Leggi said.

As a way to help investors focus on disruptive innovations, Rebecca Burke, VP, National ETF Sales, Resolute Investment Managers, highlighted options like ARK Invests flagship ARK Innovation Fund (NYSEArca: ARKK), which seeks to invest in the cornerstone companies taken from healthcare, technology and industrial sectors that focus on investing in disruptive innovation. Such companies may include ones that benefit from big data, cloud computing, cryptocurrencies, the sharing economy, genomic sequencing, molecular medicine, agricultural biology, 3D printing, energy storage, and autonomous vehicles.

For more targeted exposures, investors can look to theARK Industrial Innovation ETF (NYSEArca: ARKQ), ARK Web x.0 ETF (NYSEArca: ARKW), ARK Genomic Revolution Multi-Sector Fund (NYSEArca: ARKG),ARK Fintech Innovation ETF (ARKF) and ARK 3D Printing ETF (CBOE: PRNT).

Additionally, the ARK Israel Innovative Technology ETF (Cboe: IZRL) provides access to Israeli companies whose main business operations are causing disruptive innovation in the areas of genomics, health care, biotechnology, industrials, manufacturing, the Internet or information technology.

The active strategies aim for a negative correlation of relative returns to traditional value strategies and low correlation of relative returns to traditional growth strategies. For instance, only 1% of S&P 500 Index stocks are represented in ARKs Disruptive Innovation Strategy.

Financial advisors who are interested in learning more about opportunities through innovation can watch the webcast here on demand.

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Why ETF Investors Should Consider Allocating to Innovation - ETF Trends

The JNU scientists say their revamped BCG vaccine, which will carry antigen protein of coronavirus (SARS-CoV-2) as well, would offer long term immunity to against novel coronavirus which has so far affected 40 lakh people across the world killing 2.8 lakh of them.

Lead researcher, Prof Gobardhan Das, centre of molecular medicine at Jawaharlal Nehru University, New Delhi, says, Our aim is to generate a recombinant BCG that expresses various antigenic proteins derived from SARS-CoV-2.Once we identify antigens that produce neutralizing antibodies, we will map the epitopes from each of these antigens and stitch them together to generate a new multi-epitopic and potentially immunogenic novel antigen. Our recombinant BCG strain expressing this novel antigen will serve as vaccine against SARS-CoV2.

However, Dr Able Lawrence, Immunologist at Sanjay Gandhi Postgrad Institute Lucknow says the BCG vaccine has no impact on covid19 otherwise India would never had so many cases of corona infection. Moreover, he cities studies claiming that the proportion of migrant Indians catching covid19 was more than the native citizens in other countries.

On scientific terms, it seems the recombinant vaccine might not work as the coronavirus triggers interferon L1 and L6 response in the patient leading to complications, and BCG vaccine also raises the IL1 and IL6 adding to the problem, says Dr Lawrence.

Dr Om Shrivastav, Infectious Disease expert at Mumbais Jaslok, Reliance and Kasturba hospital, agrees to Dr Lawrence, and adds, Instead of rushing into development of various vaccines using different portion of antigens, I would like to wait for a vaccine which could offer protection to at least 60-70 percent people.

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The Dialogue with Kanchan: Centre of Molecular Medicine at JNU has started working on a COVID 19 vaccine by tweaking the BCG vaccine - Free Press...

SAN FRANCISCO, May 14, 2020 /PRNewswire/ --Lexent Bio, Inc., a precision oncology company developing novel liquid biopsy systems, today announced the use of its blood-based whole genome assay, Confera Dx, in a proof of concept paper titled "Early assessment of molecular progression and response by whole-genome circulating tumor DNA in advanced solid tumors", published in Molecular Cancer Therapeutics. The paper describes results in a prospective observational cohort using Confera Dx to assess treatment response in advanced stage solid tumor patients early in the treatment course, within the first weeks after the start of treatment. Dr. Young Kwang Chae, Associate Professor of Medicine and Co-Director of Developmental Therapeutics at Lurie Cancer Center of Northwestern University served as principal investigator for this study.

Accurate and timely assessment of response to treatment is critical in optimally managing disease in patients with advanced-stage tumors. "We have significant room to improve in treatment response monitoring in terms of the time it takes to understand whether a treatment is working, as well as resolving ambiguity from current methods like imaging," states Dr. Chae. One of the promising results noted in patients receiving immune checkpoint inhibitors is that within 3-4 weeks of starting treatment, the assay was able to determine who is and is not benefiting from immunotherapy.

This research demonstrates how a blood-based treatment monitoring assay can rapidly assess the efficacy of systemic treatment for individuals with late-stage disease. With results obtained within the first weeks of treatment, patients whose tumors have experienced "biological progression" could avoid incurring the opportunity cost of continuing on ineffective therapy for weeks or months, and switch to a promising alternative approach, improving their odds of a successful outcome. Broad application is enabled by the apparent utility of this assay across most solid tumors, without regard for the systemic therapy being assessed.

"Once assay performance is confirmed in additional studies, Confera Dx will be an invaluable tool for healthcare providers and patients to help them guide their treatment course quickly and accurately," noted Dr. Haluk Tezcan, Chief Medical Officer at Lexent Bio.

With a faster, more accurate understanding of tumor response, clinicians will be able to quickly identify patient populations that do or do not significantly benefit from specific treatments, accelerating the existing feedback loop. Given the lower cost and practicality of a simple blood draw, the standard of care is poised to incorporate molecular response monitoring in the years ahead. Further, molecular response monitoring will open the door to novel trial designs, expand understanding of cancer biology throughout the course of the disease, and should substantially improve the efficiency of R&D programs for new anti-cancer treatments.

Since data collection for this publication, the Confera Dx assay has further evolved, with improvements in sensitivity. Additional studies are planned for initiation within the next 6 months.

About Lexent BioLexent Bio is a precision oncology company. The company works to shrink cancer's role in our lives, first by helping patients and clinicians make better treatment decisions, faster. The Lexent Bio team hails from clinical, scientific, engineering, computer science, and business backgrounds, and share a passion for changing the way we understand and treat cancer. The company is taking on some of the hardest problems at the intersection of unexplored cancer biology, data science, and clinical medicine. The Confera Dx Assay system is the company's first product to move into commercialization.

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Lexent Bio Announces Use of its Liquid Biopsy Assay, Confera Dx, in a Peer-Reviewed Paper Published in the Journal Molecular Cancer Therapeutics -...

Inflammation is the alarm system by which cells first respond to potential danger, but in excess, inflammation can be fatal.

In COVID-19, for example, overactive inflammation has led to severe complications and even death for many hospitalized patients.

Research in mice led by Harvard Medical School and Boston Childrens Hospital now reveals that the FDA-approved drug disulfiram, commonly used for treating alcoholism, blocks a key gatekeeper protein involved in inflammation.

Get more HMS news here

Activation of the gatekeeper protein, gasdermin D, is the final common step in the process of inflammatory cell death, or pyroptosis, and the resulting release of inflammatory cytokines seen in many serious conditions, including sepsis.

Sepsis is the leading cause of death in children in the world and contributes to about a third of deaths in hospitalized adults.

The researchers report May 4 in Nature Immunology that mice treated with disulfiram did not develop fatal sepsis, compared with untreated animals.

The findings offer hope for diseases that involve runaway inflammation, although it remains to be seen whether the results can be replicated in people.

This research discovery is coincidentally very timely today because most people think that the clinical deterioration of COVID-19 patients is mediated by a cytokine storm, or excessive release of inflammatory molecules, explained Judy Lieberman, professor of pediatrics at HMS and chair of cellular and molecular medicine at Boston Children's.

Lieberman is co-senior investigator of the study together with Hao Wu, professor of biological chemistry and molecular biology in the Blavatnik Institute at HMS and the Asa and Patricia Springer Professor of Structural Biology at Boston Children's.

Even though there has been a lot of interest, there have not been any bona fide gasdermin D inhibitors, said Wu. We screened thousands of compounds and found that the one that worked bestdisulfiramis already on the market, is inexpensive, has a 70-year history of drug safety and could be repurposed pretty quickly.

When an invading virus or bacterium enters a cell, it triggers inflammation, unleashing a cascade of events.

One key event is called pyroptosis, a "fiery" or inflammatory cell death. In pyroptosis, the cells membrane literally explodes, releasing inflammatory molecules such as interleukin-1, which causes fever.

In a paper published in Nature in 2016, Lieberman and Wu discovered that gasdermin D forms membrane pores. When these pores open, inflammatory molecules spill out of the cell, causing pyroptosis.

Too much inflammation contributes to human diseases, including sepsis, inflammatory bowel disease, gout, type II diabetes, cardiovascular disease and Alzheimers disease and is the hallmark of rare inflammatory genetic diseases.

We knew that gasdermin D is the gatekeeper of the pathway leading to pyroptosis and spillage of inflammatory cytokines, said Wu. If we could find a compound that would inhibit this particular step, that could be an attractive drug target to prevent pyroptosis when it was not needed.

Jun Jacob Hu, HMS research fellow in biological chemistry and molecular pharmacology in the Wu lab, screened more than 3,700 small molecules looking for gasdermin D inhibitors.

He found just 22 active compounds. Disulfiram was at the top of the list.

Next, the team studied mice sick with sepsis.

They observed that disulfiram blocked pyroptosis and its explosive release of inflammatory molecules. Mice treated with disulfiram survived, while those not receiving the drug died from sepsis within one day.

"There have been hundreds of clinical trials looking for drugs to stop sepsis and the overwhelming inflammatory response without success, said Lieberman.

We hope that with this new discoveryinhibiting gasdermin D that is in a critical location in the inflammatory pathwaywe could actually have a therapy that might work, Lieberman said.

Hu is co-first author of the paper along with Xing Liu of HMS, Boston Children's and the Chinese Academy of Sciences.

The team is now looking to apply these findings to the new coronavirus.

Because COVID-19 can produce an inflammatory syndrome that is very similar to sepsis, we wonder whether disulfiram can be used to treat severely ill COVID-19 patients, said Wu.

We know from a recent report that disulfiram also inhibits a coronavirus protease, one of the essential proteins of the virus causing COVID-19, she said.

Plans are already in place to study pyroptosis and coronavirus. The ultimate goal is to start a clinical trial with disulfiram in COVID-19 patients.

The truth is that gasdermin D contributes to so much pathology in the body that we think an effective gasdermin D inhibitor like disulfiram could open up many therapeutic possibilities, said Lieberman.

This study was supported in part by the US National Institutes of Health (grants DP1HD087988, R01Al139914, R01AI123265, R01AI142642, R01AI145274, R01AI141386, R01HL092020 and P01HL095489), National Natural Science Foundation of China (grant 31972897), Chinese Academy of Sciences (grant ZDBS-LY-SM008), Shanghai Municipal Science and Technology (grant no. 2019SHZDZX02) Shanghai Science and Technology Committee (grant 19QA1409800) and Flight Attendant Medical Research Institute (CIA123008).

Adapted from a post on Discoveries, the Boston Children's research and clinical innovation blog.

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Smothering the Fire - Harvard Medical School

Graduating seniors in a wide range of majors demonstrate the power of a liberal arts education. [10 min read]

As USC Dornsife College of Letters, Arts and Sciences prepares to celebrate its graduates, 10 exceptional seniors have earned a special place of honor as Dornsife Scholars.

Selected for their successes in educational fields that address both national and global questions of human value and social challenges, the students each will receive $10,000 to be used to continue their studies as graduate students and emerging professionals.

Virginia BullingtonMajor: Narrative StudiesMinor: International RelationsGPA: 3.95

Scholarly Work, Volunteerism, Awards and Achievements:

USC Dornsife has prepared me impeccably well to enact meaningful change in the world because as a student in the largest, most diverse school at USC, I have been exposed to a range of perspectives and experiences. I never felt pigeon-holed or confined to one narrow career or academic path, rather USC Dornsife encouraged me to explore. Without having the opportunity to explore, I would not have been able to develop the strong sense of identity and conviction in who I am, what I am compelled by and where I see myself. These convictions will be essential as I seek to continue studying violent conflict and mass atrocity and how to implement solutions, thus maximizing the benefits of my education.

Gloria ChengMajor: Health and Human Sciences (pre-med and psychology emphasis)GPA: 3.80

Scholarly Work, Volunteerism, Awards and Achievements:

The collective global and local experiences serving underserved populations informed my future aspirations to advocate in the health policy and non-profit sectors as a doctor in organizations such as the World Health Organization.

Thomas KimMajor: International RelationsMinor: Environmental StudiesGPA: 3.989

Scholarly Work, Volunteerism, Awards and Achievements:

What made my time as a Dornsife student unique was its experiential learning. From Thematic Options interdisciplinary mental gymnastics, I learned how to analyze and synergize complex arguments. My internship with [USC Wrigley Institute for Environmental Studies] inspired me to fight for sustainability and against inequality. The Arctic [Problems Without Passports] left me with a greater appreciation of not only the existential threat of climate change, but also empathy and the importance of mental health. My time as a Global East Asia Scholar in Japan reminded me of the joy of exploring other cultures, despite what others say about rising global populism. Cambridge University as a study abroad student opened my eyes to the perfect career avenue to make change: international law. And joining undergraduate research with the Arctic policy research team gave me perspective into how narratives are crafted and perpetuated in the international system. Each experience taught me a unique lesson in making a difference. As a senior whose last semester has been interrupted in the most unexpected way, I leave USC into a world changed by a pandemic. However, these lessons will stay with me, informing and keeping me grounded, as I strive forward to accomplish my lifelong goal, and consequently fulfill the Dornsifes commitment, to save the world.

Samantha KosaiMajor: SociologyGPA: 3.94

Scholarly Work, Volunteerism, Awards and Achievements:

All of my experiences as a Dornsife student have made me more empathetic, inquisitive, and empowered by the many facets in which I hope to make a difference. After a few years working as a research assistant, I hope to earn a Ph.D. in sociology and begin a career as a professor researching and teaching about social inequality in our carceral, education, and health care systems. My dream is to continue working on studies, like my current honors thesis, that can be used to inform policies that protect our most vulnerable populations. My desire to make a difference in this world has been fostered by all the people I have been privileged to interact with as a Dornsife student; it only feels right that I pass along their kindness and support to the next generation of leaders.

Rae LanMajor: NeuroscienceGPA: 4.0

Scholarly Work, Volunteerism, Awards and Achievements:

Like myself, David Dornsife won national titles as a USC student-athlete, and the Dornsifes have long been a leading supporter of the USC neuroscience program. Moreover, the World Vision humanitarian programs supported by the Dornsifes align with the global health policy proposals and health systems research I carried out abroad. The Dornsife legacy has framed so many of my experiences these past four years. From the tennis court to the lab, from the classroom to the community, from Southern California to England, I will continue to make connections wherever I go and to translate my educational excellence into real-world impact.

Jenna MazzaDouble Major: International Relations and SpanishGPA: 3.88

Scholarly Work, Volunteerism, Awards and Achievements:

From my time with the Global Womens Narratives Project to Dornsife Study Abroad to working with Los Angeles immigrants as a part of my upper division international relations coursework in forced migration, my Dornsife experience has formulated my lifes commitment to support all women both through one-on-one interactions and policy measures.

Sameer Nair-DesaiDual Major: Economics and International Relations (Global Business)GPA: 3.94/4.0

Scholarly Work, Volunteerism, Awards and Achievements:

As the Dornsifes noted, To see the results of your efforts improving someones life is something you wont ever forget. My time at Dornsife has pushed me towards this same realization. Often, those excluded from education are not undeserving, but rather underserved. I strongly believe talent and hard work should dictate life outcomes, not the birth lottery. [USC Dornsife] has motivated, educated and prepared me towards realizing this vision.

Erin PinedaMajor: International RelationsGPA: 3.905

Scholarly Work, Volunteerism, Awards and Achievements:

Through scholarships like SOAR [Student Opportunities for Academic Research], the School of International Relations Internship Fund, and the Hovel Scholarship for German Studies, USC Dornsife opened the door to opportunities that helped me discover my passion for immigration issues, which I will use to advocate for immigration reform in the U.S. To accomplish this goal, I will go to law school and later join the Department of Homeland Security to draft policies that are more just and human-rights-oriented than the legislation currently governing the U.S. immigration system. While conducting interviews with Venezuelan immigrants in Peru, I witnessed first-hand the power of public policy to positively impact peoples lives. Because of the well-rounded and globally-oriented education I received as a Dornsife student, I feel well-equipped to apply the lessons learned abroad and the expertise.

Lisa de RafolsDouble Major: Economics and International RelationsMinor: FrenchGPA: 3.74

Scholarly Work, Volunteerism, Awards and Achievements:

Dornsife gave me a dynamic space to find my academic footing and then the concrete pathways to explore my interests and satiate my curiosity. Having zeroed in on the field I would like to work in after I graduate, my perspective on the subject has been indelibly shaped by my time as a Dornsife student. Beyond the impact of my experiences abroad through USC Dornsife, my time on campus was equally consequential: The critical thinking skills I learned in my Thematic Option courses will allow me to dig deeper when trying to find solutions for climate refugees, my courses on Francophone literature will provide an insight into the connections between refugee and diaspora communities, the econometrics I learned as an economics major will allow me to evaluate the effectiveness of policy interventions the list could go on and on. Ultimately, I am convinced that I will always carry the ethos of USC Dornsife with me long after I leave this campus.

Megan SmithDouble Major: International Relations (honors) and FrenchGPA: 3.878/4.0

Scholarly Work, Volunteerism, Awards and Achievements:

The education I have received from USC Dornsife pushed me to be courageous in my learning and gain tools integral to professionalizing my passion. Now, I am emboldened as a global citizen to take risks and trust my voice as I continue my pursuit of forming peace.

About the program

The Dornsife Scholars program honors Dana and David Dornsife, renowned philanthropists with the highest regard for education. Available exclusively to outstanding graduating seniors whose major courses of study are at USC Dornsife, the program underscores the importance of core academic disciplines of the humanities, social sciences and natural sciences. Recipients demonstrate a commitment to educational excellence and the advances that allow for improving the lives of people and addressing pressing global problems.

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Dornsife Scholars exemplify academic distinction with an international perspective > News > USC Dornsife - USC Dornsife College of Letters, Arts...

Global Nuclear Medicine Molecular Imaging Technology Market: Trends Estimates High Demand by 2027

Nuclear Medicine Molecular Imaging Technology Market report 2020, discusses various factors driving or restraining the market, which will help the future market to grow with promising CAGR. The Nuclear Medicine Molecular Imaging Technology Market research Reports offers an extensive collection of reports on different markets covering crucial details. The report studies the competitive environment of the Nuclear Medicine Molecular Imaging Technology Market is based on company profiles and their efforts on increasing product value and production.

This Report covers the manufacturers data, including: shipment, price, revenue, gross profit, interview record, business distribution etc., these data help the consumer know about the competitors better. This report also covers all the regions and countries of the world, which shows a regional development status, including market size, volume and value, as well as price data.

The final report will add the analysis of the Impact of Covid-19 in this report Nuclear Medicine Molecular Imaging Technology industry.

Adapting to the recent novel COVID-19 pandemic, the impact of the COVID-19 pandemic on the global Nuclear Medicine Molecular Imaging Technology market is included in the present report. The influence of the novel coronavirus pandemic on the growth of the Nuclear Medicine Molecular Imaging Technology market is analyzed and depicted in the report.

Some of the companies competing in the Nuclear Medicine Molecular Imaging Technology market are: Toshiba, GE Healthcare, Segami Corporation, Philips Healthcare, Siemens Healthcare.

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The report scrutinizes different business approaches and frameworks that pave the way for success in businesses. The report used Porters five techniques for analyzing the Nuclear Medicine Molecular Imaging Technology Market; it also offers the examination of the global market. To make the report more potent and easy to understand, it consists of info graphics and diagrams. Furthermore, it has different policies and development plans which are presented in summary. It analyzes the technical barriers, other issues, and cost-effectiveness affecting the market.

Global Nuclear Medicine Molecular Imaging Technology Market Research Report 2020 carries in-depth case studies on the various countries which are involved in the Nuclear Medicine Molecular Imaging Technology market. The report is segmented according to usage wherever applicable and the report offers all this information for all major countries and associations. It offers an analysis of the technical barriers, other issues, and cost-effectiveness affecting the market. Important contents analyzed and discussed in the report include market size, operation situation, and current & future development trends of the market, market segments, business development, and consumption tendencies. Moreover, the report includes the list of major companies/competitors and their competition data that helps the user to determine their current position in the market and take corrective measures to maintain or increase their share holds.

What questions does the Nuclear Medicine Molecular Imaging Technology market report answer pertaining to the regional reach of the industry

The report claims to split the regional scope of the Nuclear Medicine Molecular Imaging Technology market into North America, Europe, Asia-Pacific, South America & Middle East and Africa. Which among these regions has been touted to amass the largest market share over the anticipated duration

How do the sales figures look at present How does the sales scenario look for the future

Considering the present scenario, how much revenue will each region attain by the end of the forecast period

How much is the market share that each of these regions has accumulated presently

How much is the growth rate that each topography will depict over the predicted timeline

A short overview of the Nuclear Medicine Molecular Imaging Technology market scope:

Global market remuneration

Overall projected growth rate

Industry trends

Competitive scope

Product range

Application landscape

Supplier analysis

Marketing channel trends Now and later

Sales channel evaluation

Market Competition Trend

Market Concentration Rate

Reasons for Buying this Report

This report provides pin-point analysis for changing competitive dynamics

It provides a forward looking perspective on different factors driving or restraining market growth

It provides a six-year forecast assessed on the basis of how the market is predicted to grow

It helps in understanding the key product segments and their future

It provides pin point analysis of changing competition dynamics and keeps you ahead of competitors

It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

TABLE OF CONTENT:

Chapter 1:Nuclear Medicine Molecular Imaging Technology Market Overview

Chapter 2: Global Economic Impact on Industry

Chapter 3:Nuclear Medicine Molecular Imaging Technology Market Competition by Manufacturers

Chapter 4: Global Production, Revenue (Value) by Region

Chapter 5: Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6: Global Production, Revenue (Value), Price Trend by Type

Chapter 7: Global Market Analysis by Application

Chapter 8: Manufacturing Cost Analysis

Chapter 9: Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10: Marketing Strategy Analysis, Distributors/Traders

Chapter 11: Nuclear Medicine Molecular Imaging Technology Market Effect Factors Analysis

Chapter 12: GlobalNuclear Medicine Molecular Imaging Technology Market Forecast to 2027

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Research on Nuclear Medicine Molecular Imaging Technology Market (impact of COVID-19) with Top Players: Toshiba, GE Healthcare, Segami Corporation,...

SOUTH SAN FRANCISCO, Calif., May 14, 2020 (GLOBE NEWSWIRE) -- Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, today announced results from the myCare-009-01 and myCare-009-02 clinical studies in which Cellworks Singula performed as a superior predictor of complete response (CR) to therapies for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) cancer patients compared to physician prescribed treatments (McNemars p < 0.00001).

Cellworks Singula correctly predicted 88.5% of AML responders and non-responders with 97.0% sensitivity and 68.0% specificity, compared to a 70.2% physician prescribed treatment response rate in the myCare-009-01 study. Cellworks Singula also correctly predicted 73.3% of MDS responders and non-responders with 97.0% sensitivity and 68.0% specificity, compared to a 37.7% physician prescribed treatment response rate in the myCare-009-02 study. Cellworks Singula was a significant predictor of overall survival (p-value < 0.0001) and provided predictive information above and beyond physician prescribed treatments in both studies.

The complete results from the myCare-009-01 and myCare-009-02 clinical studies are now available in the ASCO Meeting Library as abstracts e19502 and e19528, respectively.

These studies validate that Cellworks Singula is a leap forward for Personalized Medicine, said Dr. Guido Marcucci, MD, Chair and Professor, Department of Hematologic Malignancies Translational Science, Director, Gehr; Family Center for Leukemia Research, Professor, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope; and Primary Investigator for the myCare-009-01 and myCare-009-02 clinical studies. Most AML and MDS patients have not just one, but multiple molecular aberrations, each of which impacts how individual patients respond to treatments. Cellworks Singula is a breakthrough technology that biosimulates how individual AML and MDS patients with multiple aberrations respond to specific therapies and then produces personalized therapy response predictions with very high accuracy. This novel capability has the potential to increase AML and MDS therapy response rates and improve patient outcomes.

The current overall outcomes for AML and MDS patients remain relatively poor. Physicians select therapies for patients based on information that only considers cytogenetics and single molecular aberrations and ignores other potentially impactful molecular pathways, downstream effects and patient-specific omics data that have the potential to inform more effective treatments.

Cellworks biosimulation is an exciting technology that delivers Personalized Medicine to AML and MDS patients, said Dr. Anthony Stein, MD, Hematologist/Oncologist, Director of the Leukemia Program; Co-Director of the Gehr Family Center for Leukemia Research; Clinical Professor of Hematology & Hematopoietic Transplantation at City of Hope; and Primary Investigator for the myCare-009-01 and myCare-009-02 clinical studies. These studies show that Cellworks Singula can accurately predict how an individual AML or MDS patient will respond to specific therapies. These precise, data-driven predictions can enable physicians to avoid prescribing inefficacious treatments and can empower physicians to make more efficacious therapy decisions based on their patients unique molecular biology.

Cellworks Singula therapy response predictions are generated through extensive biosimulation of a personalized patient disease model based on the patients multi-omics data. Utilizing an in-silico model of thousands of genes, Cellworks Singula analyzes the downstream pathway impact of genomic, proteomic, transcriptomic and epigenomic aberration information on a patients disease. These downstream effects generate phenotypic impact, which are calculated against specific drugs or drug combinations to determine treatment efficacy. The Cellworks biosimulation platform can predict an individual patients therapy response prior to receiving the treatment, thereby reducing the patient risks and payer costs of unsuccessful treatments and saving lives.

myCare-009-01 Clinical Study

An independent cohort of 494 AML patients, 2 to 85 years in age (median age 54) and treated with physician prescribed therapy, were randomly selected for this prospective retrospective study. Patient omics data from PubMed was used for the study. The accuracy of Cellworks Singula therapy response predictions was compared to the accuracy of prescribed therapies and clinical outcomes. Accuracy comparisons were enabled using McNemars test to account for the correlation between Cellworks Singula and physician recommendations. Logistic regression was used to model complete response (CR) as a function of age, prescribed therapies and Cellworks Singula against non-response (NR). Similar analyses were performed for overall survival (OS) using proportional hazards regression.

Study results show that Cellworks Singula is a superior predictor for complete response (CR) in AML patients (McNemars 2 = 72.0, p < 0.0001) with an overall predictive accuracy of 88.5% (Exact 95% CI: 85.3%, 91.1%) relative to physician prescribed treatments, compared to a physician prescribed treatment response rate of 70.2% (95% CI: 66.0%, 74.2%). Cellworks Singula exhibited 97.1% sensitivity (95% CI: 94.8%, 98.6%) and 68.0% specificity (95% CI: 59.8%, 75.5%). Cellworks Singula was also an independent predictor for OS (HR = 2.080, p < 0.0001) after adjusting for patient age (p = 0.0018) and physician prescribed treatment (p = 0.0011). For all 100 true negatives, Cellworks Singula generated alternative standard of care therapy selections with predicted clinical response.

myCare-009-02 Clinical Study

An independent cohort of 146 MDS patients aged 28 to 89 years (median age 69) and treated with physician prescribed therapy were randomly selected for this prospective retrospective study. Patient omics data from PubMed and The Cancer Genome Atlas (TCGA) was used for the study. The accuracy of Cellworks Singula therapy response predictions was compared to the accuracy of prescribed therapies and clinical outcomes. Accuracy comparisons were enabled using McNemars test to account for the correlation between Cellworks Singula and physician recommendations. Multivariate logistic regression modeled complete response (CR) as a function of patient age, physician prescribed treatment and Cellworks Singula against non-response (NR).

Study results show Cellworks Singula is a superior predictor for complete response (CR) in MDS patients (McNemars 2 = 42.0, p < 0.0001) with an overall predictive accuracy of 73.3% (Exact 95% CI: 65.3%, 80.2%) relative to physician prescribed treatment, compared to a physician prescribed treatment response rate of 37.7% (95% CI: 30.0%, 46.1%). In the study, Cellworks Singula exhibited 90.9% sensitivity (95% CI: 80.0%, 97.0%) and 62.6% specificity (95% CI: 51.8%, 72.6%). In multivariate regression analysis, Singula (p < 0.0001) remained an independent predictor for CR after adjusting for patient age (p = 0.0759) and PPT (p = 0.0496).

We are committed to advancing Personalized Medicine, said Yatin Mundkur, CEO of Cellworks. Oncologists seek the ability to consistently prescribe cancer treatments with a high level of confidence that the chosen therapy will produce a response for an individual patient. Cellworks multi-omics biosimulation makes it possible to accurately predict whether a patient will respond to specific therapies. This Personalized Medicine knowledge can improve patient outcomes, reduce payer costs and ultimately save lives.

About Cellworks Group

Cellworks Group, Inc. is a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology. Using innovative multi-omics modeling, computational biosimulation and Artificial Intelligence heuristics, Cellworks predicts the most efficacious therapies for patients. The Cellworks unique biosimulation platform is a unified representation of biological knowledge curated from heterogeneous datasets and applied to finding cures. Backed by Sequoia Capital and Artiman Ventures, Cellworks has the worlds strongest trans-disciplinary team of molecular biologists, cellular pathway modelers and software technologists working toward a common goal attacking serious diseases to improve the lives of patients. The company is based in South San Francisco, California and has a research and development facility in Bangalore, India. For more information, visit http://www.cellworks.life and follow us on Twitter @cellworkslife.

All trademarks and registered trademarks in this document are the properties of their respective owners.

Media Contacts:

Barbara ReichertReichert Communications, LLCBarbara@reichertcom.com415-225-2991

Michele Macpherson, Chief Business OfficerCellworks Group, Inc.michele.macpherson@cellworksgroup.com

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Cellworks Singula Predicts Personalized Therapy Responses for AML and MDS Patients with Higher Accuracy than Physician Prescribed Treatments -...

The recently published market study by GLOBAL MARKETERS.BIZ highlights the current trends that are expected to influence the dynamics of the Molecular Microbiology market in the upcoming years. The report introspect the supply chain, cost structure, and recent developments pertaining to the Molecular Microbiology market in the report and the impact of the COVID-19 on these facets of the market. Further, the micro and macro-economic factors that are likely to impact the growth of the Molecular Microbiology market are thoroughly studied in the presented market study.

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Leading Players Are :

RocheQiagenIlluminaAbbottHologicBioMerieuxDanaher (Cepheid)Myriad GeneticsDAAN GeneAgilentGenomic HealthBDFoundation Medicine

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Critical Data in the Molecular Microbiology Market Report

Company share analysis and competition landscape

Recent trends and notable developments in the Molecular Microbiology market space

Growth projections of each market segment and sub-segment during the forecast period

COVID-19 impact on the global Molecular Microbiology market

Recent innovations, product launches, and technological advances relevant to the Molecular Microbiology market

Regional Assessment

The regional assessment chapter in the report offers an out and out understanding of the potential growth of the Molecular Microbiology market across various geographies such as:

Application Assessment

The presented study ponders over the numerous applications of the Molecular Microbiology and offers a fair assessment of the supply-demand ratio of each application including:

Market Taxonomy

By Type

Quantitative PCR Detection Diagnostic KitsPathogenic Microorganisms Diagnostic Kits

By Application

HumanVeterinary

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By Region

North America

Latin America

Europe

China

Japan

SEA and Other APAC

MEA

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The report resolves the following doubts related to the Molecular Microbiology market:

1. Who are the leading market players operating in the current Molecular Microbiology market landscape?

2. Which region is expected to dominate the Molecular Microbiology market in terms of market share and size during the forecast period?

3. What are the various factors that are likely to contribute to the growth of the Molecular Microbiology market in the upcoming years?

4. What is the most impactful marketing strategy adopted by players in the Molecular Microbiology market?

5. What is the projected CAGR growth of application 1 during the forecast period?

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Global Molecular Microbiology Market Trends, Applications, Competitive Strategies and Future Outlook 2025 - Cole of Duty

Precision medicine transplant care specialist CareDx and genomic diagnostics company Veracyte announced today an exclusive agreement to commercialize CAreDxs organ transplant-rejection tests on Veracytes diagnostic platform, the nCounter FLEX Analysis System.

CareDx said its HistoMap gene expression profiling test, that it announced last year is under development, will run on the Veracyte system. HistoMap is being developed using the Human Organ Transplant (HOT) panel from the Banff Foundation for Allograft Pathology. CareDx will manage the global commercialization of HistoMap

With HistoMap added to our strong KidneyCare and HeartCare offerings, we will ensure that biopsies performed are reproducibly clinically relevant. This fits well into our approach of multimodality testing and patient stratification, said Peter Maag, chairman and CEO of CareDx, in a press release. We are glad to partner with Veracyte to make these solutions available for transplant patients.

The partnership with CareDx is the first by Veracyte with a diagnostics company with the aim of expanding the number of genomic tests it offers on its nCounter instrument. Veracyte acquired the global diagnostic rights to nCounter in December from NanoString Technologies. Earlier this year, Veracyte also announced its first biopharmaceutical partnershipwith Acerta Pharma, the hematology research and development arm of AstraZenecathat was enabled by the NanoString transaction.

Bonnie Anderson, Veracytes chairman and CEO added: We believe this agreement will expand the menu of advanced genomic tests we offer on the nCounter platform, helping us broaden the installed base of instruments and increase adoption of our tests in global markets. Ultimately, this collaboration helps us further achieve our vision of becoming a leading global provider of advanced genomic testing.

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CareDx, Veracyte Enter Exclusive Partnership for Transplant Rejection Testing - Clinical OMICs News

Peter Ellis, University of Kent; Mark Wass, University of Kent, and Martin Michaelis, University of Kent

We dont know much about SARS-CoV-2, the virus that causes COVID-19, but we are learning new things about it every day. The latest bit of the jigsaw puzzle comes from a small study conducted in China, which found SARS-CoV-2 RNA (the viruss genetic code) in the semen of young COVID-19 patients.

The study, published in JAMA Network Open, involved 38 patients undergoing treatment for severe COVID-19 disease at Shangqiu Municipal Hospital in Henan province. Fifteen of the patients provided a semen sample during the acute phase of their illness and 23 shortly after recovering. In four of the 15 patients with acute disease and in two of the 23 recovering patients, SARS-CoV-2 RNA was found in the semen samples.

These new findings differ from the results of an earlier study involving 12 COVID-19 patients and a case report. However, the earlier investigations focused on patients with mild disease after they had recovered, whereas the current study focused on hospitalised patients with severe disease, and all samples in this latest study were taken during disease or very shortly after recovery. In fact, all of the semen samples that were found to have viral RNA in recovering patients were taken at day two and day three after recovery. So the differences between the earlier studies and the current one are probably the result of differences in disease severity and the time of sampling.

The testes, along with the eyes, placenta, foetus and central nervous system, are considered to be immunoprivileged sites, which means they are protected from severe inflammation associated with an immune response. This is probably an evolutionary adaptation that protects vital structures. So these are niches where viruses may be protected from the host immune response.

Immunoprivileged sites gained attention as places where viruses can persist after disease recovery during the 2013-16 West African Ebola virus outbreak. Ebola virus remained detectable in the semen of some survivors for more than three years and Ebola virus transmission through sexual intercourse can occur months after the patient has recovered.

We dont know what the implications of the latest findings are yet. The presence of viral RNA in the patients semen does not necessarily indicate the presence of infectious virus. So it will be critical to show whether infectious virus can also be isolated from the semen of SARS-CoV-2 patients and survivors.

If this is possible, the next question will be whether as the current data suggests SARS-CoV-2 is predominantly found in the semen of patients with severe disease or whether significant virus levels can also be detected in the semen of patients with mild disease or, indeed, in the semen of asymptomatic people.

Even if these things are shown, its probably of minor concern for virus spreading during acute infection. Given the high contagiousness of SARS-CoV-2 by non-sexual routes, it is difficult to imagine how this could be substantially increased by sexual transmission. The only scenario where sexual transmission of SARS-CoV-2 might be a problem would be if the virus persisted in the testicles for extended periods, and if COVID-19 survivors could sexually transmit the virus after their recovery.

We need more studies to investigate whether this is possible. In the meantime, it would still be sensible for those recovering from COVID-19 to use a condom until further research is done to clarify how long infectious virus stays in semen.

Peter Ellis, Lecturer in Molecular Biology and Reproduction, University of Kent; Mark Wass, Reader in Computational Biology, University of Kent, and Martin Michaelis, Professor of Molecular Medicine, University of Kent

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Coronavirus found in semen of young men with COVID-19 - Bay 93.9

Five Wayne State University professors who have distinguished themselves with significant scholarly achievements were recently honored with 2020 WSU Board of Governors Faculty Recognition Awards.

The awards are offered annually to full-time faculty members who make outstanding contributions to scholarship and learning. Each recipient receives a citation from the board, an engraved wall plaque and a monetary award.

This year's recipients are:

Gov. Bryan C. Barnhill II recognized Heng for the publication of Genome Chaos: Rethinking Genetics, Evolution and Molecular Medicine (Academic Press, 2019). Heng introduces new genome-based evolutionary theories that will shape the field of genomic theory for decades to come. He introduces new frameworks of genome-defined system inheritance and genome variation-mediated macroevolution, including hisoriginal and creative genome theory, which re-examines existing theories of cancer emergence.

Heng is a pioneer in visualizing how genome reorganization is central to both microcellular and macrocellular evolution and applying it to cancer development. His book will serve as resource for researchers across a number of fields, including cancer biology, molecular medicine, genomics and evolutionary biology.

Gov. Mark Gaffney recognized Jung for the publication of Balkan Blues: Consumer Politics After State Socialism (Indiana University Press, 2019). In Balkan Blues, Jung draws on 16 years of ethnographic fieldwork in Bulgaria to explore the ways that citizens participate in and experience the making of a consumer society during the transition from a production-oriented, centrally planned economy to a consumption-oriented capitalist market economy.

Consumption, she argues, is not merely a question of individual choice or an expression of cultural identity; rather, through the daily consumption practices of shopping and using utilities, citizens define rights and demand responsibilities in a globalized consumer society. Balkan Blues raises important questions about the role of the state and of citizens in 21st century neoliberal economies.

Gov. Sandra Hughes OBrien recognized Past for the publication of Italian Ecocinema Beyond the Human (Indiana University Press, 2019). The work is an original study of the material dimensions of cinema and its relation to a network of agents that include people and countries, above ground and underground landscapes, living bodies, industry and oil, economic processes, and geopolitical dynamics.

Through an exploration of five films shot in different parts of Italy, Pasts study takes into account what happens to the environment while filming on location and the material traces the film industry leaves behind as well as the impression the natural environment leaves on film. Italian Ecocinema seeks to uncover cinemas ecological footprint and demonstrate cinemas potential to offer alternative outlooks on the human and the nonhuman world.

Gov.Marilyn Kelly recognized Progovac for the publication of A Critical Introduction to Language Evolution:Current Controversies and Future Prospects (Springer, 2019). Progovac offers criteria to evaluate the myriad competing hypotheses that attempt to account for the course of language evolution throughout history.

This book introduces new foundational goals, concepts and definitions of current approaches to the origin, changes and understanding of the biological basis not only of social interactions, but also and more generally of our human nature and existence. Progovacs research is a major contribution to the interdisciplinary study of a field that is now recognized as central for scholars in the social sciences, cultural studies and the humanities.

Gov. Dana Thompson recognized Trimpin for receiving the Biemann Medal from the American Society for Mass Spectrometry (ASMS). The ASMS recognizes significant achievements made in the early stages of a career in basic or applied mass spectrometry. It is the highest honor a mid-career scientist contributing to the advancements of measurements can receive.

In 2019, the ASMS awarded the medal to Trimpin for her discovery and development of novel ionization processes that the ASMS believes will advance mass spectrometry into new applications, with considerable societal benefits in diagnostics, security, environment, and other areas, by providing real-time, information-rich data. Trimpins research accomplishments show levels of creativity that clearly place her among the very best in her field.

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Board of Governors honors professors for scholarly achievements - The South End

Foundation Medicine, Inc. today announced that FoundationOneCDx has been approved by the U.S. Food and Drug Administration (FDA) for use as the companion diagnostic (CDx) to aid in identifying patients with non-small cell lung cancer (NSCLC) for whom treatment with Tabrecta (capmatinib) may be appropriate. Tabrecta is the first and only therapy approved by the FDA for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to MET exon 14 skipping (METex14). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). FoundationOne CDx is the only FDA-approved broad comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostic claims. It is currently approved as the companion diagnostic test for 21 unique therapies.

NSCLC accounts for approximately 85% of lung cancer diagnoses,1 3 to 4% of which have MET exon 14 skipping.2 This milestone marks an important advancement for patients with METex14 mutated metastatic NSCLC, as there have previously been no treatment options available specifically for this diagnosis.

"Because non-small cell lung cancer is a particularly aggressive and difficult to treat form of cancer, taking a comprehensive and validated approach to genomic testing is critical to help guide physicians treatment decisions," stated Foundation Medicines Chief Medical Officer Brian Alexander, M.D., M.P.H. "FoundationOne CDx is a powerful tool for identifying patients with mutations that lead to MET exon 14 skipping who may be eligible for treatment with Tabrecta. This simultaneous therapy and companion diagnostic approval marks an important step forward in the treatment of rare cancer and demonstrates how deep collaboration across industry partners can advance patient care."

As part of the strategic collaboration with Novartis, which now includes two companion diagnostics for the Novartis portfolio of targeted oncology and immuno-oncology therapeutics, a companion diagnostic for Tabrecta is also in development for Foundation Medicines liquid biopsy assay.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

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Foundation Medicine Receives FDA Approval for FoundationOneCDx as the Companion Diagnostic for Tabrecta (capmatinib), the Only FDA-Approved MET...