Monthly Archives: May 2022

During foetal development, before the biological clock starts ticking on its own, genes respond to rhythmic behaviour in the mother. The hypothalamus's suprachiasmatic nuclei (SCN) are the body's timekeepers. Rhythmic gene activity in SCN cells governs the activity of many other genes locally and throughout the body, influencing circadian rhythmic behaviour such as feeding and sleeping. But rhythmic gene activity begins late in foetal development, raising the question of whether maternal influences entrain SCN gene activity before birth.

The authors compared gene activity in SCN tissue from pregnant rats kept in the dark under two conditions. Lesioned rats had disrupted SCNs and limited food access to impose a circadian rhythm in their activity that their SCNs could not sustain. Control rats had intact SCNs and free access to food.

They found that, within the SCNs of both sets of fetuses, there was a very small set of genes whose timing patterns differed between the two groups and a much larger set whose activity oscillated in sync with each other.

The study reveals that distinct maternal signals rhythmically control a variety of neuronal processes in the fetal rat suprachiasmatic nuclei before they begin to operate as the central circadian clock. The results indicate the importance of a well-functioning maternal biological clock in providing a rhythmic environment during fetal brain development.

Continued here:
While the fetal clock develops, moms behaviour tells the time - The Daily Star

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that the company and its collaborators will present a total of 26 abstracts at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting held virtually and in person in Chicago from June 3-7, 2022.

Presentations focus on the power of genomic research to provide physicians and researchers with the latest insights on innovative treatment strategies for patients, including those with early-stage cancers, and cancers with rare or complex alterations. Highlights of this data include:

At Foundation Medicine, we provide doctors and researchers with tools to help them find answers and take action on treatment options for patients across cancer types and stages. At this years ASCO, we will demonstrate the expanded capacity of our tests to detect actionable complex biomarkers and alterations in earlier stages of cancer to support care decisions for patients, said Priti Hegde, PhD, chief scientific officer at Foundation Medicine. We are proud of our many collaborations on this research with partners across the oncology community. These collaborations reinforce Foundation Medicines role as an essential partner with the scientific expertise and real-world data to support efficient progress for equitable patient care.

The Value of Liquid Biopsy in Identifying Actionable Alterations

LCMC LEADER neoadjuvant screening trial: LCMC4 evaluation of actionable drivers in early stage lung cancers. Abstract #TPS8596.

In collaboration with the Lung Cancer Research Foundation, the Lung Cancer Mutation Consortium, and Memorial Sloan Kettering Cancer Center, this Trial in Progress abstract details the umbrella trial design of the LCMC4 Evaluation of Actionable Drivers in EaRly-Stage Lung Cancer (LEADER) clinical trial. Foundation Medicines tissue-based CGP test, FoundationOneCDx, and its blood-based CGP test, FoundationOneLiquidCDx, will both be used in the LEADER trial to screen for 10 actionable driver mutations in 1,000 patients with high-risk, resectable NSCLC who are candidates for neoadjuvant therapy. Results will enable selection of neoadjuvant therapy and enrollment onto independent therapeutic trials with genomically matched neoadjuvant treatment, standard therapies, or other trials if no driver is detected.

CtDNA shed as a tool to select immune checkpoint inhibitors (ICPI) with or without chemotherapy for patients (pts) with advanced non-small cell lung cancer (aNSCLC). Abstract #9045.

Using the CGDB, this study with Gustave Roussy Cancer Center investigated circulating tumor DNA (ctDNA) shed as an indicator to support treatment selection for patients with advanced NSCLC. Researchers found that elevated plasma tumor fraction (TF) can identify patients at risk of early progression on immune checkpoint inhibitors (ICPI) who may benefit from chemotherapy in addition to an ICPI. In patients with low/intermediate TF, the study found that outcomes on ICPIs alone are similar to those receiving both chemotherapy and ICPI treatment, suggesting TFs ability as a non-invasive tool to identify patients for single-agent ICPI.

Genomic landscape of acquired resistance to targeted therapies in patients with solid tumors: a study from the National Center for Precision Medicine (PRISM). Abstract #3016.

Researchers from Gustave Roussy Cancer Center and Institut Bergoni set up a study using FoundationOneLiquid CDx to detect ctDNA in an effort to characterize the landscape of secondary resistance mechanisms in patients with solid tumors. While many targeted therapies are approved for treatment in solid tumors, acquired resistance to these therapies remains as a barrier limiting the ultimate effectiveness of these treatments. Researchers reported that polyclonal secondary genomic alterations represent a frequent clinical resistance mechanism that may explain the low rate of sustained complete remission for patients treated with targeted therapies.

The Power of Real-World Genomic Data to Shape the Future of Cancer Care

A real-world (rw) evidence study quantifying the clinical value of multi-gene testing in early-stage lung adenocarcinoma (LUAD). Abstract #8525.

In collaboration with Cleveland Clinic Cancer Center and Flatiron Health, this study used the CGDB to assess the potential value of CGP in early-stage lung adenocarcinoma (LUAD). Researchers found that CGP of early-stage LUAD can identify EGFR, ALK, ROS1, RET and other drivers and enable appropriate selection of targeted therapies and timely use of effective first line therapy at recurrence. By avoiding the use of ICPIs in patients unlikely to respond, CGP could represent a way to avoid ineffective treatment and risk of tyrosine kinase inhibitor (TKI)-associated toxicity.

Biomarker associations of immune checkpoint inhibitor versus chemotherapy effectiveness in first-line metastatic endometrial carcinomas: A real-world study. Abstract #5596.

Using real world data from the CGDB, this study in partnership with the Yale School of Medicine evaluated TMB greater than 10 mutations per megabase and MSI-high as predictive biomarkers for ICPI benefit in comparison to standard of care chemotherapy in first line metastatic endometrial cancer (mEC). More favorable time to next treatment and overall survival were observed on ICPI versus chemotherapy in first line treatment among those with high TMB and/or MSI-high, but not those without. The results of this study suggest that a randomized controlled trial in this setting using these biomarkers has a favorable chance of success to develop a chemotherapy-sparing first line option for patients with mEC.

Clinical and genomic characteristics of pts with durable benefit from immune checkpoint inhibitors (ICPI) in advanced non-small cell lung cancer (aNSCLC). Abstract #9048.

In collaboration with Dana-Farber Cancer Institute, this study queried the CGDB to better understand patients with advanced NSCLC who had a durable response to ICPIs. The two-year mark has increasingly become a milestone in progression-free patients with advanced NSCLC, with a subset experiencing ongoing disease control even after discontinuing active treatment. In a cohort of 4,030 advanced NSCLC patients, 4.6% were free of progression or treatment failure at 24 months, with a median overall survival of almost 5 years. 41% of those patients stopped immunotherapy usage before the two-year mark. Researchers also found that elevated TMB was associated with durable benefit on ICPIs, as well as prolonged progression-free survival after the 2-year mark and deserves further investigation as a biomarker for prolonged benefit from ICPIs in advanced NSCLC.

Ancestry-based differences in gene alterations in non-small cell lung cancer: Real-world data using genetic ancestry analysis. Abstract #9125.

In this study, researchers investigated alteration prevalence in a large real-world NSCLC cohort, stratified by genetic ancestry. Together with Juntendo University Graduate School of Medicine and others, the study looked at FoundationCore, Foundation Medicines robust real-world dataset, to reveal ancestry-associated differences in genomic alterations in NSCLC. Age and sex were also associated with differences in prevalence of gene alterations and immunotherapy-associated biomarkers, such as high TMB status.

Real-world (rw) analysis of quantitative MET copy number (CN) as a biomarker in advanced NSCLC (aNSCLC). Abstract #9123.

Researchers used real-world data from the CGDB to explore the genomic landscape of MET amplification in NSCLC and its association with outcomes to MET TKIs. In partnership with the University of Colorado, CGP results from 64,521 tissue and 5,177 blood-based NSCLC samples were queried for MET amplification, which was detected in 3.3% of tissue samples and 3.2% of high TF blood samples. MET amplification was found to be associated with response to MET TKIs. In TKI-nave patients, MET copy number was negatively correlated with the presence of a concurrent NSCLC driver, suggesting that further studies evaluating MET copy number as a predicative biomarker for MET TKIs, and as an indicator of MET dependence to aid therapy section, are warranted.

Activating MET kinase domain mutations define a novel molecular subtype of non-small cell lung cancer that is clinically targetable with the MET inhibitor elzovantinib (TPX-0022). Abstract #9124.

In this study conducted in partnership with Dana-Farber Cancer Institute and Turning Point Therapeutics, researchers investigated a novel, actionable subtype of NSCLC characterized by activating MET tyrosine kinase domain (MET-TKD) mutations in the absence of METex14 mutations. Looking at a multi-institutional dataset of cancers that underwent genomic profiling, including FoundationCore, researchers found that potentially actionable MET-TKD mutations represent a novel genomic subtype in 0.6-0.9% of NSCLC and occur in the absence of other known drivers in a subset of cases.

The following is a list of select abstracts that will be presented at the meeting. To access all abstracts being presented by Foundation Medicine and its collaborators, please visit: meetinglibrary.asco.org.

Follow Foundation Medicine on Twitter and LinkedIn for more updates from #ASCO22 and visit us in person at Booth #13019.

Abstract #

Title

Collaborator

Product

Poster Discussions

Abstract 3016,Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT

Genomic landscape of acquired resistance to targeted therapies in patients with solid tumors: A study from the National Center for Precision Medicine (PRISM)

National Center for Precision Medicine, Gustave Roussy Cancer Center, Institut Bergoni

FoundationOneLiquid CDx

Abstract LBA9023,Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

Efficacy/safety of entrectinib in patients (pts) with ROS1-positive (ROS1+) advanced/metastatic NSCLC from the Blood First Assay Screening Trial (BFAST)

Roche/Genentech

Clinical trial assay based on FoundationOneLiquid CDx

Poster Presentations

Abstract 5596,Saturday, June 4, 2022, 1:15 PM-4:15 PM CDT

Biomarker associations of immune checkpoint inhibitor versus chemotherapy effectiveness in first-line metastatic endometrial carcinomas: A real-world study

Yale School of Medicine, Flatiron Health

Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB)

Abstract 4102,Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT

Conquer Cancer Merit Award Winner: Genomic profile of intrahepatic cholangiocarcinoma with MTAP loss

MD Anderson Cancer Center

FoundationCore

Abstract 3130,Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT

Increasing targeted therapy options for patients with relapsed cancer with broader somatic gene panel analysis from the primary tumor: The Profiler02 randomized phase II trial

Roche

FoundationOneCDx

Abstract TPS8596,Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

LCMC LEADER neoadjuvant screening trial: LCMC4 evaluation of actionable drivers in early stage lung cancers

Lung Cancer Research Foundation, Lung Cancer Mutation Consortium, Memorial Sloan Kettering Cancer Center

FoundationOneCDx & FoundationOneLiquid CDx

Abstract 9045,Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

CtDNA shed as a tool to select immune checkpoint inhibitors (ICPI) with or without chemotherapy for patients (pts) with advanced non-small cell lung cancer (aNSCLC)

Gustave Roussy Cancer Center, Flatiron Health

Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB)

Abstract 8525,Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

A real-world (rw) evidence study quantifying the clinical value of multi-gene testing in early-stage lung adenocarcinoma (LUAD)

Cleveland Clinic Cancer Center, Flatiron Health

Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB)

Abstract 9048,Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

Clinical and genomic characteristics of pts with durable benefit from immune checkpoint inhibitors (ICI) in advanced non-small cell lung cancer (aNSCLC)

Dana-Farber Cancer Institute

Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB)

Abstract 9125,Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

Conquer Cancer Merit Award Winner: Ancestry-based differences in gene alterations in non-small cell lung cancer: Real-world data using genetic ancestry analysis

Juntendo University, Stanford University, Chugai, Ohio State University

FoundationCore

Abstract 9123,Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

Conquer Cancer Merit Award Winner: Real-world (rw) analysis of quantitative MET copy number (CN) as a biomarker in NSCLC

University of Colorado

Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB)

Abstract 9124,Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

Activating MET kinase domain mutations define a novel molecular subtype of non-small cell lung cancer that is clinically targetable with the MET inhibitor elzovantinib (TPX-0022)

Dana-Farber Cancer Institute, Turning Point Therapeutics

FoundationCore

Abstract 8587,Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

Conquer Cancer Merit Award Winner: Genomic characterization of thymic epithelial tumor from real-world data

Juntendo University, Stanford University, Chugai, Ohio State University

FoundationCore

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit http://www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOneCDx

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.F1CDxLabel.com.

About FoundationOneLiquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. 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. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit http://www.F1LCDxLabel.com.

Foundation Medicine, FoundationOne and FoundationCore are a registered trademark of Foundation Medicine, Inc.

Source: Foundation Medicine

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Foundation Medicine and Collaborators to Share More Than 20 Abstracts Featuring New Data at the 2022 American Society of Clinical Oncology Annual...

First companion diagnostic claim for Illumina's TruSight Oncology Comprehensive (EU) test enables targeted therapy with Bayer's VITRAKVI (larotrectinib) for patients with NTRK fusion cancer

SAN DIEGO, May 24, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI (larotrectinib), in accordance with the approved therapeutic labeling.

TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test which combines less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This helps maximize the chances of identifying an actionable alteration so that patients can be treated with a targeted therapy or enrolled into a clinical trial based on their unique tumor genomic profile. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients harboring this genetic alteration with an opportunity to benefit from larotrectinib, a genomically matched treatment.

"This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina's broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine," said Paula Dowdy, Senior Vice President and General Manager of Illumina for Europe, the Middle East, and Africa. "We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behindwe don't want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy."

Across most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be challenging to detect as these genes fuse with many different partners, many of them previously unknown. Most CDx tests are specific to one type of cancer, but the NTRK claim is pan-cancer, enabling TSO Comprehensive (EU) to target multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient's biopsy, to inform treatment with larotrectinib.

"Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer," said Christine Roth, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Bayer's Oncology Strategic Business Unit. "The CE marking of Illumina's TSO Comprehensive (EU) assay inclusive of NTRK gene fusion detection for VITRAKVI is an important advance in enabling precision oncology for patients in Europe. Assays that enable precision oncology through comprehensive genomic testing are crucial for informing optimal treatment plans and help to ensure the best possible outcomes for cancer patients. We look forward to continuing to collaborate with Illumina to ensure that more patients are evaluated comprehensively inclusive of NTRK gene fusions."

The performance of TSO Comprehensive (EU) with NTRK fusions was assessed by analytical and clinical validation studies. Pooled data from three clinical trials, LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431) and SCOUT (NCT02637687), were used to demonstrate the clinical effectiveness and safety of TSO Comprehensive (EU) in identifying NTRK1, NTRK2 and NTRK3 gene fusion positive patients who may be eligible for treatment with larotrectinib. The primary endpoint was the overall response rate (ORR), measured as the patient presenting either a complete response, a surgical complete response or partial response, to larotrectinib.

"We were delighted to be the clinical study partner for Illumina in this significant achievement of the first CDx claim for the TSO Comprehensive (EU) panel," said Professor Richard Kennedy, Global VP of Biomarker Development & Medical Director, Almac Diagnostic Services. "TSO Comprehensive (EU) represents a powerful and versatile platform with a broad range of cancer-relevant content, and we recognize its value to our biopharma partners, for the development and delivery of companion diagnostics to further precision medicines."

Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine.

About TruSight Oncology Comprehensive (EU)

TruSight Oncology Comprehensive is an in vitro diagnostic test that uses targeted next generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina NextSeq 550Dx instrument. The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, deletions and gene amplifications from DNA, and gene fusions and splice variants from RNA. The test also reports a Tumor Mutational Burden (TMB) score and Microsatellite Instability (MSI) status.

The test is intended as a companion diagnostic to identify cancer patients for treatment with the targeted therapy listed in Table 1, in accordance with the approved therapeutic product labeling. In addition, the test is intended to provide tumor profiling information for use by qualified healthcare professionals in accordance with professional guidelines and is not conclusive or prescriptive for labeled use of any specific therapeutic product.

Table 1: Companion Diagnostics Indication

Tumor Type

Biomarkers

Targeted Therapy

Solid Tumors

NTRK1, NTRK2, and NTRK3

Gene Fusions

VITRAKVI (larotrectinib)

To learn more about TruSight Oncology Comprehensive, click here.

About VITRAKVI (larotrectinib)

VITRAKVI (larotrectinib), a first-in-class oral TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. The compound has demonstrated high response rates and highly durable responses of over four years in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors. To date, it has the largest dataset and longest follow-up data of any TRK inhibitor. The trials are still ongoing, with the latest dataset presented at the European Society for Medical Oncology (ESMO) Congress 2021 and additional updates planned to be presented at upcoming scientific meetings.

Larotrectinib is approved under the brand name Vitrakvi in more than 40 countries around the world, including the U.S., countries of the European Union (EU), and most recently in China. Filings in other regions are underway or planned. In the EU, the product is approved for the treatment of adult and pediatric patients with solid tumors that harbor a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.

Use of forward-looking statements

This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) our ability to manufacture robust instrumentation and consumables; (ii) challenges inherent in developing, manufacturing, and launching new products and services; (iii) our ability to obtain regulatory approval for our products from government agencies and reimbursement from payors; (iv) our ability to successfully partner with other companies and organizations to develop new products, expand markets, and grow our business, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to http://www.bayer.com.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit http://www.illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.

Investors:

Salli Schwartz858.291.6421IR@illumina.com

Media:

Adi RavalUS: 202.629.8172PR@illumina.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/illumina-introduces-new-pan-cancer-companion-diagnostic-to-match-patients-with-rare-genetic-mutations-to-targeted-therapy-301552561.html

SOURCE Illumina, Inc.

Company Codes: NASDAQ-NMS:ILMN

Here is the original post:
Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy - BioSpace

SINGAPORE - The Republic is embarking on a mission to map the DNA and the complete set of genes of 100,000 Singaporeans - to unravel clues that will further the population's health and well-being.

By scrutinising genes and dissecting biological processes at the molecular level, doctors and researchers can pinpoint the underlying causes of cancer and chronic ailments, and identify new ways to prevent or slow down disease progression.

This would help to pave the way for new drugs, faster diagnostics and targeted treatments through precision medicine, said Professor Patrick Tan, executive director of Precision Health Research, Singapore (Precise), the entity that will helm the population study.

Over the next three years, the whole genomes of 100,000 healthy Singaporeans - between the ages of 30 and 80 - will be sequenced and analysed to create one of Singapore's largest research data sets.

Malay and Indian participants will comprise 40 per cent of the 100,000, and the rest will be Chinese.

The project, called SG100K, will end up as one of Asia's leading reference genome databases since Singapore's ethnic diversity captures more than 80 per cent of Asia's diversity.

On Thursday (May 26), Precise and genomics technology leader Illumina inked a partnership agreement to kick-start the SG100K effort.

The whole genome sequences will amount to 20 petabytes of data - which is equivalent to about 200,000 high-definition movies. The human brain can store around 2.5 petabytes of memory.

To date, the project has enrolled 70,000 participants from existing cohort studies, and is working towards recruiting the remaining 30,000 participants at a rate of 300 participants per week, said Deputy Prime Minister Heng Swee Keat, who attended the signing ceremony and toured Illumina's premises in Woodlands on Thursday.

Mr Heng added that Precise has in place robust safeguards to protect the privacy and security of data collected from people.

For one, Illumina has invested heavily in safeguarding its software, and researchers need approval to access the anonymised data, said Prof Tan.

The remaining 30,000 participants will be recruited mainly through referrals from the healthcare clusters, and from those who sign up for The Health For Life In Singapore population cohort study, led by Lee Kong Chian School of Medicine.

Under the SG100K project, participants' blood samples will be sent for whole genome sequencing.

The genomic data will also be linked to other physical health measurements taken from the participants. This means that participants have to undergo a whole day of tests, which includemeasuring blood sugar and cholesterol levels, a fitness test using trackers, and answer a questionnaire on their lifestyle.

Read the rest here:
Project SG100K: DNA of 100000 Singaporeans to be mapped to identify new ways to prevent diseases - The Straits Times

image:Mitochondria being engulfed by autophagosome view more

Credit: Jlio C. B. Ferreira/USP

A study by Brazilian scientists points to the probable biological mechanism that modulates the accumulation of mutant mitochondrial DNA in cells during aging, especially in the liver. The mechanism is called autophagy, a process of cellular cleansing that destroys organelles, including mitochondria, and recycles their components. The findings resolve a paradigm in the field and raise a hypothesis for the emergence of diseases associated with mitochondrial DNA, paving the way for the development of therapies.

The study was supported by FAPESP and is reported in an articlepublishedin the journalAutophagy.

Mitochondria are responsible for cellular respiration, processing substrates to supply energy to the organism. They have their own genome inherited solely from the mother, unlike the DNA found in cell nuclei, which is inherited from both parents. Mitochondrial DNA is also subject to mutations, some of which can lead to diseases. According to estimates, disorders caused by mitochondrial DNA mutations affect at least one in every 5,000 people worldwide. One of these disorders is MELAS syndrome (Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes), which can cause seizures, pain, altered consciousness and focal neurological deficits, among other symptoms.

Besides the disorders due directly to mitochondrial DNA mutations, there are others to which mutations contribute at least partly, saidMarcos Chiaratti, last author of the article. These include diabetes, Parkinsons and Alzheimers, he added, indicating that the study could pave the way for treatments involving autophagy in the context of different diseases.

Chiaratti is a professor in the Department of Genetics and Evolution at the Federal University of So Carlos (UFSCar) in So Paulo state. The other authors of the article are researchers affiliated with UFSCar and the University of So Paulo (USP) in Brazil, and with Cedars-Sinai Medical Center and Stanford University in the United States. The study was led by Chiaratti and supported by FAPESP via seven projects (16/07868-4,17/05899-2,17/04372-0,18/20028-0,20/15412-6,19/25049-9, and12/50231-6).

Aging

Research has shown that mitochondrial DNA mutations build up as part of aging. One of the oldest questions in biomedicine is why this is so, Chiaratti said. Theories that blame mitochondrial DNA replication or cell proliferation have been ruled out by previous studies. Given the importance of autophagy in the life cycle of cells and mitochondrial recycling, Chiaratti and colleagues decided to see if it played a role in mitochondrial DNA mutations. Autophagy is in vogue. The scientific literature on the topic is growing, he said. The 2016 Nobel Prize in Physiology or Medicine was awarded to Japanese cell biologist Yoshinori Ohsumi for his discoveries relating to autophagy mechanisms.

Methodology

Practically all humans have a small amount of mutant DNA. The coexistence of mutant and wild-type (non-mutant) mitochondrial DNA in a cell is called heteroplasmy. In this study, Chiaratti et al. used mice with heteroplasmy at 30%: a mutant strain known as NZB/BINJ (or NZB) accounted for 30% of their mitochondrial genome, while the rest was C57BL/6N (or BL6), considered normal.

The researchers cross-bred these mice with others that lacked the geneatg7specifically in the liver. Without this gene, the requisite machinery to make autophagy possible simply disappears. We spent almost a year just on breeding, Chiaratti said.

After this period, they had two groups of mice: a control group with NZB mitochondrial DNA and the geneatg7; and a group with NZB but without the geneatg7in liver cells, so that autophagy in the liver was impossible (liver-specificatg7knockout).

Experiments were conducted to see if autophagy affected the buildup of mutant mitochondrial DNA over time. Ten days after birth, similar levels of NZB were found in the tissue of both groups of mice, but after 21 days NZB began to accumulate in the livers of the control animals, while the knockout group had the same proportion as before. After 100 days, when mice are considered adults, the controls had even higher levels of NZB while the knockouts had practically the same levels as when they were born, making the difference between the two groups even more evident and suggesting that autophagy plays a role in the age-related buildup of mutant mitochondrial DNA.

The researchers then set out to validate this finding by conducting an experiment with mice that lacked the genePrkn, which is responsible for a specific stage of autophagy. InPrknknockout mice, autophagy occurred but was defective. We again compared these mice with the controls, Chiaratti said. Although thePrknknockout mice did eventually accumulate NZB mitochondrial DNA, the buildup was smaller than for the control group. This reinforced the theory that autophagy is involved since manipulation of another gene associated with it led to changes in the data.

The researchers also found that autophagy mostly cleared BL6 mitochondrial DNA in controls, which presumably explained the higher levels of NZB. On exploring this possibility further, they discovered that the presence of NZB enhanced mitochondrial respiratory capacity in liver cells. We, therefore, postulated that autophagy might help eliminate less functional mitochondria while conserving the fittest, which of course would be positive, Chiaratti said.

Another stage of the study entailed isolation of fibroblasts, a type of connective tissue cell, from the mice, and the in vitro observation that NZB mitochondrial DNA levels in them fell over time. However, when drugs that stimulated autophagy were applied, the decline was reversed. This was further evidence of the importance of autophagy to mitochondrial DNA regulation, Chiaratti said.

Next steps

While NZB was considered mutant in the mice involved in these experiments, the results show that it is not detrimental to the liver. On the contrary, it enhances mitochondrial respiratory capacity in liver cells, as already noted. Now we need to investigate the phenomenon with different mitochondrial DNAs that are known to be pathological, Chiaratti said.

If autophagy also proves relevant in this context, the researchers can begin to test treatments that stimulate the cell cleansing mechanism against diseases affected by the functioning of mitochondria. Other possibilities for future research, Chiaratti added, will include the role of autophagy in mitochondrial DNA accumulation in tissue elsewhere in the body apart from the liver and isolated fibroblasts.

###

About So Paulo Research Foundation (FAPESP)

The So Paulo Research Foundation (FAPESP) is a public institution with the mission of supporting scientific research in all fields of knowledge by awarding scholarships, fellowships and grants to investigators linked with higher education and research institutions in the State of So Paulo, Brazil. FAPESP is aware that the very best research can only be done by working with the best researchers internationally. Therefore, it has established partnerships with funding agencies, higher education, private companies, and research organizations in other countries known for the quality of their research and has been encouraging scientists funded by its grants to further develop their international collaboration. You can learn more about FAPESP atwww.fapesp.br/enand visit FAPESP news agency atwww.agencia.fapesp.br/ento keep updated with the latest scientific breakthroughs FAPESP helps achieve through its many programs, awards and research centers. You may also subscribe to FAPESP news agency athttp://agencia.fapesp.br/subscribe.

Autophagy deficiency abolishes liver mitochondrial DNA segregation

27-Feb-2022

Here is the original post:
Study reveals potential target for treatment of diseases associated with mitochondrial DNA mutations - EurekAlert

NEW YORK, May 25, 2022 /PRNewswire/ --Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene fusions. Seribantumab is currently being evaluated in the ongoing Phase 2 CRESTONE study, for which initial data will be presented in an oral presentation at the upcomingAmerican Society of Clinical Oncology (ASCO) 2022 Annual Meeting on Tuesday, June 7, 2022.

"There are currently no approved therapies that specifically target NRG1 fusions, and therefore, receipt of Fast Track designation in a tumor-agnostic setting is a significant step in addressing this unmet need," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "NRG1 fusions are a type of genomic alteration that causes unregulated cell growth and proliferation in a variety of solid tumors, and we look forward to working closely with the FDA as we continue exploring the potential of seribantumab to improve outcomes for patients whose tumor harbors this unique oncogenic driver."

Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval. Additionally, the designation allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as a Rolling Review, which means a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab was granted Fast Track designation from the FDA for the tumor-agnostic treatment of patients whose solid tumors harbor NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the Phase 2 CRESTONE Study

CRESTONE (Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions; NCT04383210) is a Phase 2 tumor-agnostic study evaluating seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States, Australia, and Canada. For more information visit http://www.NRG1fusion.com.

About Elevation Oncology, Inc.

Elevation Oncology is founded on the belief that every patient living with cancer deserves to know what is driving the growth of their disease and have access to therapeutics that can stop it. We aim to make genomic tests actionable by selectively developing drugs to inhibit the specific alterations that have been identified as drivers of tumor growth. Together with our peers, we work towards a future in which each tumor's unique genomic test result can be matched with a purpose-built precision medicine to enable an individualized treatment plan for each patient. Our lead candidate, seribantumab, is intended to inhibit tumor growth driven by NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion. Details on CRESTONE are available at http://www.NRG1fusion.com. For more information visit http://www.ElevationOncology.com.

Forward Looking Statements:

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, expected timing of announcements of clinical results, potential benefits of seribantumaband the company's other future product candidates, potential opportunities to expand the company's product candidate pipeline, potential market opportunities for seribantumaband the company's other future product candidates, the ability of seribantumaband the company's other future product candidates to treat their targeted indications, and our expectations about our cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, the impact of the COVID-19 pandemic on the Company's business, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, the Company's ability to establish and maintain collaborations with third parties and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Elevation Oncology Investor and Media ContactCandice Masse, 978-879-7273Senior Director, Corporate Communications & Investor Relations[emailprotected]

SOURCE Elevation Oncology

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Elevation Oncology Announces FDA Fast Track Designation Granted to Seribantumab for the Tumor-Agnostic Treatment of Solid Tumors Harboring NRG1 Gene...

INOVIO's DNA medicines immunotherapy in combination with Libtayo elicits vaccine-associated immune responses when administered with RT/TMZ to newly diagnosed GBM patients

INO-5401 + INO-9012 + Libtayoelicits cancer antigen-specific T cells

55% of MGMT methylated subjects remain alive at a median of 32.5 months

Dr. David Reardon, Principal Investigator, to present on June 6, 2022 at ASCO

PLYMOUTH MEETING, Pa., May 27, 2022 /PRNewswire/ -- Inovio (NASDAQ: INO) announced results from the company's novel Phase 1/2 trial of INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo (cemiplimab) in the treatment of newly diagnosed glioblastoma (GBM), including encouraging median overall survival (OS) data from fifty-two subjects. Median OS duration in unmethylated MGMT (Cohort A) was 17.9 months. Median OS data in MGMT Methylated patients (Cohort B) are being presented for the first time, at a median of 32.5 months, which compares favorably to historical comparisons (23.2-25 months).

Overall, INO-5401 + INO-9012 is demonstrated to be tolerable and immunogenic when administered with Libtayo and RT/TMZ (radiation and temozolomide) to newly diagnosed GBM patients. Notably, INO-5401 elicited antigen-specific T cells that may infiltrate GBM tumors. The data from this study was selected to be presented in an oral presentation by Dr. David Reardon on Monday, June 6, 2022, at the 2022 American Society of Clinical Oncology (ASCO) at the McCormick Place Convention Center in Chicago, Illinois.

Presentation Details: June 6, 2022, 12:42 12:54 p.m. CDTPresenting Author: David A. ReardonCentral Nervous System Tumors Session

Abstract #2004: Intramuscular (IM) INO-5401 + INO-9012 with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma

Fifty-two subjects were enrolled: 32 in Cohort A; 20 in Cohort B (35% women; median age 60 years [range 19-78 years]). The adverse event profile was consistent with known single-agent (INO-5401, INO-9012, EP or Libtayo) events; most events were Grade 2 and no related events were Grade 4. Median OS durations in Cohorts A and B were 17.9 months (95% CI 14.5-19.8) and 32.5 months (95% CI 18.4-not reached), respectively. Flow cytometry revealed activated, antigen specific CD4+CD69+PD1+ and CD8+CD69+PD1+ T cells, the latter with lytic potential as defined by presence of perforin and granzyme A. Both subsets exhibited HR<1.0 and p<0.05 when accounting for a 0.1% T cell frequency change, translating to a 23% and 28% reduced risk of death at 18 months, respectively.

A post-hoc exploratory analysis showed that gene expression levels of INO-5401 antigens and immune cell markers from pre-treatment tumor tissues were similar between alive and deceased groups; however, the alive group displayed significant differential expression of genes regulating apoptosis, proliferation, and immune responses. Post-treatment tumor tissue displayed altered gene expression for immune-related markers versus pre-treatment tissue, including markers of T cell infiltration, activation, and lytic potential.

Dr. David Reardon, Clinical Director, Center for Neuro-Oncology of Dana-Farber Cancer Institute and coordinating principal investigator of the study said, "GBM remains one of the most aggressive and hard-to-treat cancers. The fact that we have seen this novel combination trial of a T cell generating DNA medicine combined with a PD-1 checkpoint benefit a large percent of trial participants past 32 months is very encouraging. These latest results and continued development are welcoming as it continues to improve upon a standard of care which was defined 17 years ago and remains sub-optimal for our patients with GBM."

Dr. Jeffrey Skolnik, INOVIO's Senior Vice President, Clinical Development, said, "We, along with our collaborative partner Regeneron, remain encouraged with the progress to date from this novel combination therapy study. As concluded in the abstract, INO-5401 + INO-9012 has an acceptable risk/benefit profile and elicits robust immune responses that may correlate with a potentially enhanced survival when administered with Libtayo and RT/TMZ to newly diagnosed GBM patients. Our goal is to build upon INO-5401's ability to elicit antigen-specific T cells that can infiltrate GBM tumors and complement the clinically-active profile of Libtayo to a potentially larger study in the future."

INO-5401, INO-9012, Libtayo, and the combination of these products have not been approved or evaluated by any Regulatory Authority worldwide for the treatment of newly diagnosed GBM.

Study Design

The trial was designed to evaluate safety, immunogenicity and efficacy of INO-5401 and INO-9012 in combination with Libtayo, with radiation and chemotherapy, in subjects with newly diagnosed glioblastoma (GBM). This is a Phase 1/2, open-label, multi-center trial conducted in 52 evaluable patients with GBM. There are two cohorts in this trial. Cohort A includes 32 participants with a tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. Cohort B includes 20 participants with a tumor with a MGMT methylated promoter. Both cohorts received INO-5401 and INO-9012 and Libtayo at the same doses and on the same dosing schedule, and both cohorts received radiation and TMZ. For more information of the clinical study, see http://www.clinicaltrials.gov, identifier NCT03491683.

About INO-5401 and INO-9012

INO-5401 encodes for INOVIO's SynCon antigens for hTERT, WT1, and PSMA, and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted hTERT, WT1, and PSMA among a list of important cancer antigens, designating them as high priorities for cancer immunotherapy development. These three antigens were reported to be over-expressed, and often mutated, in a variety of human cancers including glioblastoma, and targeting these antigens may prove efficacious in the treatment of patients with cancer. INO-9012 encodes for IL-12, which is a T cell immune activator.

About Glioblastoma (GBM)

GBM is the most common and aggressive type of brain cancer and remains a devastating disease for both patients and caregivers. Its prognosis is extremely poor, with very few new therapies approved over the last 10 years. The median overall survival for patients receiving standard of care therapy is approximately 15 to 22 months and the median progression-free survival is approximately 7-10 months. In the U.S., the estimated annual incidence of GBM is 11,362 cases or 3.21 cases per 100,000 persons and the median age at diagnosis is 65 years.

About INOVIOINOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and help treat people with cancer and HPV-associated diseases. Our DNA medicines are delivered using our proprietary smart device to produce a robust and tolerable immune response against targeted pathogens and cancers.

Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, Defense Advanced Research Projects Agency/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense/Department of Defense, HIV Vaccines Trial Network, International Vaccine Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium, National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit http://www.inovio.com.

CONTACTS:

Media: Jeff Richardson, 267-440-4211, jrichardson@inovio.comInvestors: Ben Matone, 484-362-0076, ben.matone@inovio.com

This press release contains certain forward-looking statements relating to our business, including our plans to develop DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials and the availability and timing of data from those studies and trials, and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2021, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

View original content:https://www.prnewswire.com/news-releases/inovio-announces-survival-results-for-ino-5401--ino-9012-in-combination-with-libtayo-cemiplimab-in-patients-with-newly-diagnosed-gbm-at-asco-annual-meeting-2022-301556446.html

SOURCE INOVIO Pharmaceuticals, Inc.

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INOVIO Announces Survival Results for INO-5401 + INO-9012 in Combination with Libtayo (cemiplimab) in Patients with Newly Diagnosed GBM at ASCO Annual...

DUBLIN, May 27, 2022 /PRNewswire/ -- The "Single-use Technologies for Biopharmaceuticals: Global Markets" report has been added to ResearchAndMarkets.com's offering.

The report summarizes the market, including a market snapshot and company profiles of key players in the sole-use technologies market. It provides a comprehensive market breakdown with in-depth information about each segment. The overview section of the report describes market trends and dynamics, including drivers, limitations, challenges, and opportunities for the market.

Furthermore, it provides information about market development and future trends useful for organizations, including distributors and exporters. It analyzes critical market players' revenue, product portfolio and recent activities. It further includes strategies adopted by emerging market players with strategic recommendations for new market entrants. Outright information is provided in the report, consisting of historical and current market size, including the market's future potential.

The report will also help inform market players and new entrants about the production and export of goods and services to original equipment manufacturers. The market is segmented based on technology, components, applications, and end user. A geographical market analysis is provided for all the major segments. The report offers a country-level analysis of the market to understand major components better.

Report Includes

Single-use bioreactor technology has gained considerable importance in biotechnology manufacturing over the years. Several single-use options are available. Scalability is the biggest limitation. The industry's willingness to use single-use bioreactors is influenced by production parameters, product value and development time. It takes more time to complete comparative studies with conventional stainless-steel bioreactors as the rate of implementation is lower than that of acceptance, thus making single-use technology highly desirable in the biopharmaceutical industry.

However, more clarity and understanding regarding the regulatory requirements for single-use bioreactor technology are needed. For example, U. S. FDA regulations for the Cord Blood Registry (CBR) do not explicitly mention single-use bioreactor technology, even though a large number of Investigational New Drug (IND) programs have been approved by the FDA using such systems.

The major factors influencing the growth of the market include increasing demand for personalized medicine, extensive ongoing development efforts, a strong product portfolio, and large application areas for single-use systems. Additionally, lower cost and reduction in the time necessary in the biomanufacturing process when using single-use technology are further driving the growth of the market.

The drug development rate has increased rapidly with the increasing demand for personalized medicines. This has, in turn, increased the demand for single-use technology to avoid the risk of contamination.

A strong product portfolio is further fueling the growth of the market during the forecast period. There are several companies that are offering single-use technologies, such as Thermo Fisher Scientific Inc. , Danaher Corp. , Sartorius AG, General Electric Co. , and PendoTECH LLC. PendoTECH LLC is focused on the development of pressure sensors used to measure static and dynamic pressure of gases and liquids in biopharmaceutical processes.

It also provides a wide range of single-use products such as single-use rotary flowmeters, single-use ultrasonic flowmeters and a compact low-flow ultrasonic flow meter with are usable fluid path.

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market and Technology Background

Chapter 4 Biologics Process Development Pathway and Application of Single-Use Technologies

Chapter 5 Covid-19 Impact on Market

Chapter 6 Market Breakdown by Technology

Chapter 7 Market Breakdown by Single-Use Component

Chapter 8 Market Breakdown by Application

Chapter 9 Market Breakdown by End-user

Chapter 10 Market Breakdown by Region

Chapter 11 Patent Review

Chapter 12 Competitive Analysis and Market Opportunities

Chapter 13 Company Profiles

Chapter 14 Appendix: Abbreviations

For more information about this report visit https://www.researchandmarkets.com/r/xzilpr

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

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SOURCE Research and Markets

See the article here:
Outlook on the Single-use Technologies for Biopharmaceuticals Global Market to 2026 - Increasing Demand for Personalized Medicine is Driving Growth -...