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MedNess: bite-size biopharma and medtech news

18th March, 2020
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HIGHLIGHTS
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Drug Approvals
European Commission approves Venclyxto + Gazyvaro in 1L CLL patients based on results of Ph 3 CLL14 study
“Venclyxto plus Gazyvaro is the first fixed-duration, chemotherapy-free treatment option that has been shown to help patients with untreated chronic lymphocytic leukaemia live longer without their disease progressing,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This is an important step forward for adults with this disease in the EU, who will now have an effective treatment option that enables them to end treatment after one year.”
FDA grants accelerated approval to Opdivo® (nivolumab) + Yervoy® (ipilimumab) for HCC patients Previously Treated with Sorafenib based on results from Ph 1/2 CheckMate -040 trial
“HCC is an aggressive disease in need of different treatment approaches,”4,5,6 said Anthony B. El-Khoueiry, M.D., lead investigator and associate professor of clinical medicine and phase I program director at the Keck School of Medicine, University of Southern California (USC) and the USC Norris Comprehensive Cancer Center. “The overall response rate observed in the Opdivo + Yervoy cohort of the CheckMate -040 trial underscores the potential of this dual immunotherapy as a possible treatment option for patients.”
Regulatory News
FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of NSCLC patients with EGFR Exon 20 insertion mutations
"JNJ-6372 is a novel bispecific antibody that we believe has the potential to benefit patients with Exon 20 mutation insertions who often do not respond to currently available oral EGFR-targeted or immune checkpoint inhibitor therapies," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "This Breakthrough Therapy Designation is a significant milestone in our ongoing efforts to advance JNJ-6372 in clinical development and target genetically-defined lung cancer."
Fast Track Designation for Balstilimab & Zalifrelimab in Advanced Cervical Cancer
"We are pleased that balstilimab and zalifrelimab have been granted Fast Track designation by FDA in recognition of the high unmet medical need in second line cervical cancer. The Fast Track designation confers important benefits, including the potential eligibility for a Priority Review," said Dr. Jennifer Buell, President and COO, Agenus. "We are excited about the prospect of making these novel agents available to women who suffer from metastatic cervical cancer. We look forward to continuing to work with FDA as we advance new treatment options for patients with cancer."  
Trial Results
FAILED TRIAL: Phase III GY004 trial of cediranib + Lynparza (olaparib) in platinum-sensitive relapsed ovarian cancer patients fails to meet primary endpoint of significant PFS improvement
José Baselga, Executive Vice President, Oncology R&D, said: “Despite these disappointing results, we remain committed to expanding on the benefits already demonstrated with Lynparza for patients with advanced ovarian cancer. We will work closely with NRG Oncology and the NCI to review the full results to inform our ongoing research.”
FAILED TRIAL: Ph 3 TOURMALINE-MM2 trial of NINLARO™ (ixazomib) + lenalidomide + dexamethasone in 1L transplant ineligible multiple myeloma patients failed to improve PFS significantly
“There is a need for treatment options in transplant ineligible patients. We remain committed to advancing the field of multiple myeloma and continue to drive innovation through ongoing research and development,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “We are confident there will be numerous learnings from this trial and look forward to sharing these data with the community. We want to thank the patients and investigators for their participation in this important program.”
Click Here for more Trial Results
Trial/Program Status
TERMINATED: Phase III JAVELIN Head and Neck 100 study of avelumab + chemoradiotherapy (CRT) in LA SCCHN patients to be terminated as per DMC’s recommendation
  • Phase III JAVELIN Head and Neck 100 study was evaluating avelumab in addition to chemoradiotherapy (CRT) versus standard-of-care CRT 
  • DMC recommended to terminate the JAVELIN Head and Neck 100 trial as the study is unlikely to show a statistically significant improvement in PFS based on a preplanned interim analysis. 
  • A detailed analysis of the Phase III JAVELIN Head and Neck 100 study is being conducted and study findings will be shared with the scientific community
First Patients Dosed In Phase 3 And Phase 2 Clinical Trials Of Infigratinib In Tumors With FGFR Genetic Alterations
“Many patients with invasive urothelial carcinoma will have their cancer recur within two years after surgery,” said PROOF 302 trial lead Sumanta Pal, M.D., professor of medical oncology and therapeutics research at City of Hope Comprehensive Cancer Center. “Correspondingly, I believe there are many patients who could benefit from an oral, post-surgery treatment option that targets FGFR3 alterations, the genetic driver of many urothelial carcinomas.”
Collated by : Richa Tewari, PhD
Medness Plus - COVID-19 special
FDA issues Emergency Use Authorization to Roche’s SARS-CoV-2 Test to detect the novel coronavirus
"Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic.  It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” said Thomas Schinecker, CEO of Roche Diagnostics. “Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease.”
FDA issues Emergency Use Authorization for Thermo Fisher Scientific’s diagnostic test to detect COVID-19
“The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "At Thermo Fisher, our Mission is to enable our customers to make the world healthier, cleaner and safer. In partnership with the FDA and regulatory authorities around the world, we are committed to expanding the availability of diagnostic testing to prevent the spread of this disease." 
FDA and FTC issues warning to seven companies for selling fraudulent COVID-19 products
“The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one,” said FDA Commissioner Stephen M. Hahn, M.D. “We understand consumers are concerned about the spread of COVID-19 and urge them to talk to their health care providers, as well as follow advice from other federal agencies about how to prevent the spread of this illness. We will continue to aggressively pursue those that place the public health at risk and hold bad actors accountable.”
More updates on efforts of the FDA related to COVID-19
“We have been encouraging test developers to come to the FDA and work with us,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Since the beginning of this outbreak, more than 60 developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process. Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory developed tests for this emergency.”
Click Here for more on MedNess Plus
Collated by :  Esha Sehanobish, PhD
Medness Business
BioPharma and MedTech

NIH enters COVID biopharma consortium led by Vir Biotechnology
On 11th March 2020, Vir Biotechnology announced a research collaboration with National Institutes of Health (NIH) in advancing research on antibodies for COVID-19 treatment. Vir is already partnered with WuXi Biologics (25th Feb 2020), for commercializing its antibodies in China. Vir has a proprietary human monoclonal antibody panel derived from SARS CoV-2 survivors and has identified 2 SARS-CoV-2 antibodies that bind to the spike protein of COVID-19 at the ACE2 receptors interface. With NIH, it will now test antibody combinations for different corona viruses in animal studies. If successful, these antibodies will block viral entry into cells, conferring resistance to infection. Other partnerships include Alnylam Pharmaceuticals (4th March 2020), which will hand over potential siRNA leads for COVID-19 to Vir for in vivo testing and commercialization; and Biogen (12th March 2020) with whom Vir intends to combine licences and expertise for development, manufacturing and distribution of therapeutic COVID-19 antibodies in the worldwide market.

Torque and Cogen Immune Medicines of Flagship umbrella merge to form $220 million T cell-based immunotherapeutic company
Repertoire Immune Medicines (Cambridge, Massachusetts) is a new Flagship Pioneering venture, that is focused on providing appropriate T cell-based therapies for diseases like cancer, type-I diabetes and multiple sclerosis. On 12thMarch 2020 Flagship Pioneering announced a rational union of 2 member companies- Torque Therapeutics (with DEPLOY platform) and Cogen Immune Medicines (with DECODE platform). 
Hopeful IPO plans by 3 biotech players in COVID driven market slump
3 biotech companies- Zentalis Pharmaceuticals, Lyra Therapeutics and Ayala Pharmaceuticals- have announced million-dollar IPO plans as of March 9th 2020. Zentalis Pharmaceuticals (San Diego) has announced a $100 million IPO, banking on its star candidate Zn-c5 which is being tested for treatment of ER+/HER- advanced breast cancers as a single agent (in Phase1/2 clinical trials) and in combination with Ibrance (CDK4/6 inhibitor) from Pfizer. 
Click Here for more details
Collated by :  Divyaanka Iyer
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Debarati Banik
HealthIT
Divyaanka Iyer
MedNess Reviews
Nisha Peter, PhD
Managing Editor
Mayur Vadhvani, PhD
Consulting Editor
Abhi Dey
Consulting Editor
Ananda Ghosh, PhD
Founder
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
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