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MedNess: bite-size biopharma and medtech news

6th March, 2020
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MedNess This Week
HIGHLIGHTS
Our Sponsors
Drug Approvals
sNDA approved by FDA for neratinib + capecitabine in 3L+ advanced or metastatic HER2-positive breast cancer patients
“Although there have been many new treatment options for patients with HER2-positive breast cancer, patients still need additional treatment options once they progress” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “Based on the results of our NALA data, we believe NERLYNX® could be a promising therapeutic opportunity for these patients.”
FDA approves Sarclisa® (isatuximab-irfc) in RRMM patients
“Today’s FDA approval of Sarclisa provides a new treatment option for patients with difficult-to-treat multiple myeloma. These are patients whose disease has returned or become resistant to their prior treatments,” said Paul Hudson, Chief Executive Officer, Sanofi. “At Sanofi, we are focused on discovering and developing medicines that may change the practice of medicine, and Sarclisa offers a potential new standard of care in the United States. We continue to evaluate Sarclisa in a comprehensive clinical program in multiple myeloma, as well as in other blood cancers and solid tumors.”
Regulatory News
Positive Pre-BLA meeting with FDA makes way for a potential pathway for approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma
“We are very pleased with the positive outcome of the Pre-BLA meeting for omburtamab providing a clear regulatory path forward for a rolling BLA submission. We believe omburtamab to be essential in addressing substantial unmet medical needs for children suffering from high-risk neuroblastoma brain tumors,” said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.
Breakthrough Therapy Designation granted to IAP antagonist Debio 114 in 1L LA-SCCHN patients in combination with cisplatin-based chemoradiation therapy (CRT)
“Despite today’s current standard of care, high-risk locally-advanced head and neck cancer remains an area of unmet medical need.  This Breakthrough Therapy Designation will allow us to maximize the potential of Debio 1143 to become an innovative radio-chemo enhancing treatment for LA-SCCHN patients.”– Angela Zubel, Chief Development Officer, Debiopharm.
Click Here for more Regulatory News
Trial Results
FAILED TRIAL: Ph 3 VIALE-C (M16-043) trial of venetoclax (VENCLEXTA®) + LDAC did not meet primary endpoint of OS improvement in chemo-ineligible AML patients
"We remain committed to AML patients and our research in AML and other blood cancers," said Neil Gallagher, M.D., Ph.D., chief medical officer and vice president of development, AbbVie. "The study results, while not statistically significant, are indicative of the clinical activity of venetoclax in combination with low-dose cytarabine."
KEYTRUDA® (pembrolizumab) significantly improved PFS compared with Brentuximab Vedotin in R/R cHL Patients
“Patients with classical Hodgkin lymphoma are generally young and when they do not achieve remission following standard treatment, their cancer is challenging to treat,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “These pivotal phase 3 data indicate a statistically significant and clinically meaningful improvement in progression-free survival with KEYTRUDA compared, in head to head fashion, with the currently approved therapy of brentuximab vedotin. These data are strongly supportive of KEYTRUDA’s current indication in cHL and we plan to file these data with regulatory authorities as quickly as is possible.”
Click Here for Trial Results
Trial/Program Status
First rGBM Patient dosed in Ph 2a trial of VBI-1901 + GSK’s AS01B Adjuvant System
“We are excited to initiate enrollment in this study arm to evaluate VBI-1901 in combination with AS01B, GSK’s effective proprietary adjuvant system,” said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. “AS01B has been shown to boost T-cell mediated immunity and, building on the encouraging early immunologic and tumor response data we’ve seen to-date from the VBI-1901 with GM-CSF study arm, we look forward to evaluating the benefit this combination could have for patients with GBM, a devastating disease with few treatment options.”
First 100 Patients Enrolled in Ph 3 COSMIC-311 Trial of Cabozantinib in Relapsed Radioiodine-Refractory DTC Patients
“Given the encouraging clinical activity observed for cabozantinib in phase 1 and 2 trials in differentiated thyroid cancer, and the poor prognosis for patients who have progressed after prior VEGF receptor-targeting therapy, it is exciting to reach this milestone for COSMIC-311,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “This brings us one step closer to a first analysis that will help us better understand cabozantinib’s potential in treating patients with this intractable form of thyroid cancer. We look forward to sharing those initial results later this year.”
Click Here for Trial/Program Status
Collated by : Richa Tewari, PhD
Medness Plus
Gilead Sciences begins two Phase 3 studies of Remdesivir in the treatment of the novel coronavirus (COVID-19)
“Gilead’s primary focus is on rapidly determining the safety and efficacy of remdesivir as a potential treatment for COVID-19, and this complementary array of studies helps to give us a more expansive breadth of data globally on the drug’s profile in a short amount of time. The speed with which remdesivir has moved into clinical development for this coronavirus reflects the pressing need for treatment options and the shared commitment of industry, governments, global health organizations and healthcare providers to respond to this public health threat with the highest urgency,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
FDA approves an over-the-counter product for temporary relief of arthritis pain
Franck Riot, Head of R&D, GSK Consumer Healthcare said: “For the millions of people around the world living with arthritis, joint pain and stiffness are daily realities. At GSK, we are committed to improving the quality of life of these people and today’s approval is progress towards this, providing consumers in the US with increased access to an effective, proven arthritis pain relief option. Voltaren is currently the number 1 OTC topical pain relief brand globally, and we look forward to expanding its availability in the US.”Dr. Roy Altman, Professor of Medicine in Rheumatology at UCLA said: “Osteoarthritis treatment guidelines from several international and United States medical societies, including the 2019 American College of Rheumatology (ACR) endorse the early use of topical NSAIDs for treating arthritis pain of the knee and hand.  In contrast to prior guidelines, the recommendations are inclusive of all age groups, not just the elderly.” 
GSK and Clover Biopharmaceuticals announce research collaboration for a coronavirus vaccine candidate with pandemic adjuvant system
“At Clover we look forward to evaluating the combination of GSK’s pandemic adjuvant system and our S-Trimer as a vaccine candidate. Utilizing our proprietary Timer-Tag© technology that has been shown to be recognized by antibodies produced by multiple previously-infected coronavirus patients, S-Trimer is being rapidly developed to support global efforts in combating this current and any future coronavirus outbreaks,” said Joshua Liang, Chief Strategy Officer and Board Director at Clover. “We are proud to work with GSK, and we are encouraged by the progress of our S-Trimer vaccine program,” said Steven Gong, VP Business Development & Strategy at Clover. “To this end, we recognize that collaborations will be critical to accelerating the development of a successful new vaccine in times of emergency, and we continue to invite any interested regulatory, academic or industry parties to contact us for this noble common cause.” “We are proud to contribute to cutting edge research from scientists at Clover Biopharmaceuticals in China as part of our strategy to make our adjuvant technology available to selected partners who have a promising vaccine candidate against the newly emerged coronavirus.” said Thomas Breuer, Chief Medical Officer of GSK Vaccines. “The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people.”
Click Here for more on MedNess Plus
Collated by :  Esha Sehanobish, PhD
Medness Reviews

Corona Virus Update

As the effect of the Covid19 spreads to 54 countries, the number of people infected worldwide is nearing 100,000 with 3000 deaths. In the US, just in 72 hours number of cases rose to more than a hundred suggesting, community transmission is taking place. 

McKinsey analysts predict three outcomes: Best case scenario- containment and economic damage restrictive to Q1. Global Slowdown with the sustained transmission. Global pandemic ending in recession by 2021.  Click here for a detailed report.
Collated by :  Ananda Ghosh, PhD
Medness Business
Onco-News
Unum Therapeutics concludes Ph 1 ACTR707 programs to promote BOXR1030 program
“Following a detailed review of our operations, opportunities, and cash reserves, we believe the decisions announced today are in the best interests of all Unum stakeholders, including patients, clinicians, employees and shareholders,” said Chuck Wilson, Ph.D., President and Chief Executive Officer of Unum Therapeutics. “We remain committed to addressing the challenges of treating solid tumor cancers, and would like to thank the patients, their families, and the investigators who have made our efforts to date possible. In addition, we would like to thank Seth for his contributions to the preclinical discovery efforts here at Unum over the years and wish him the very best in his next endeavor.”
Bicycle Therapeutics plc and Genentech to discover, develop and commercialize novel Bicycle®-based immuno-oncology therapies
“Our collaboration with Genentech recognizes the potential of Bicycle’s differentiated technology, which allows us to specifically direct immune cell stimulators and other payloads to tumors in a highly targeted manner,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “In addition, the flexibility of the Bicycle platform enables rapid exploration of structure-activity relationships to fully optimize candidate molecules. We look forward to working closely with Genentech to pioneer the discovery and development of potential new cutting-edge cancer treatments based on Bicycles.”
Spring Bank Pharmaceuticals and Roche to explore the co-administration of STING agonist SB 11285 with atezolizumab (Tecentriq®) in patients with advanced solid tumors
“We are thrilled to announce a new clinical collaboration to explore our SB 11285 IV STING agonist in combination with atezolizumab (Tecentriq®) in patients with advanced solid tumors,” said Atif Abbas, M.D., Vice President & Head of Oncology/Immunology Development at Spring Bank. Dr. Abbas continued, “We believe our IV-administered STING agonist has the ability to treat a broader range of cancers and patients when used in combination with checkpoint inhibitors by potentially enhancing their potency and effectiveness, and we look forward to being able to examine this effect with atezolizumab (Tecentriq®) as well as other checkpoint inhibitors.”
Collated by : Richa Tewari, PhD
BioPharma and MedTech

Biogen Exodus

With Aducanumab story nearing climax Biogen sees rapid exodus of executives. Michael Ehler joined Apple Tree partners Limelight Bio joined as CSO in Oct 2019. Daniel Karp, corporate development EVP, also exited as of last week. This week Anirvan Ghosh, Biogen's R&D chief exits for ARCh and Bezos-funded anti-aging biotech. More news here

M&As this week 

The week of March 2 started with Gilead's acquisition of immunotherapy company Forty Seven in a 4.9M dollar deal that saw the market cap going up to ~8B. Analysts remain skeptical about how the M&A will help Gilead in the short run. 
Thermo Fisher today (March 3) announced it would buy the dutch diagnostic company Qiagen for 10.1B. With 2 mega acquisitions, the biotech world will probably see more M&As in the next two quarters. 
A timely review by LifeScienceVCs Bruce Booth on how M&A can be advantageous to the biotech ecosystem is a fantastic read. 
Collated by :  Ananda Ghosh, PhD
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 
Concept and Design: Ananda Ghosh and Nisha Peter
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