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MedNess: bite-size biopharma and medtech news

19th November, 2019
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HIGHLIGHTS
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Drug Approval
BRUKINSA™ (zanubrutinib) received FDA accelerated approval in 2L+ MCL patients
“We are working to improve outcomes for people with cancer worldwide and this approval brings us closer to realizing our mission of bringing the highest quality therapies to patients globally,” said John V. Oyler, Chairman, Co-Founder, and CEO of BeiGene. “Today’s FDA approval of BRUKINSA, following the previously granted Breakthrough Therapy designation in this indication, validates it as an important treatment option for people with relapsed or refractory MCL. We hope this is the first of many approvals for BRUKINSA as we continue to evaluate its potential in other hematologic cancers.”
Regulatory News
CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma
“People with relapsed or refractory diffuse large B-cell lymphoma have limited treatment options – especially those who are not candidates for haematopoietic stem cell transplant,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased the CHMP has recognised the potential of Polivy to provide a much-needed new treatment option for patients with this aggressive disease.”
CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment
“In the early breast cancer setting where cure is achievable, it is important to do everything possible to prevent progression to an advanced, incurable stage.” said Levi Garraway, MD PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation therefore marks a significant step forward in bringing a potentially transformative treatment option to patients in Europe with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant therapy.”
Breakthrough Therapy Designation and Priority review granted to sBLA of Opdivo (nivolumab) + Yervoy (ipilimumab) in previously treated advanced HCC patients; PDUFA Mar 2020
“The FDA’s acceptance of our application for Opdivo plus Yervoy represents important progress for patients with liver cancer in the United States, where hepatocellular carcinoma is the fastest rising cause of cancer-related death,” said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb. “Despite recent advances, hepatocellular carcinoma remains a difficult-to-treat cancer and patients are in need of additional effective treatment options. We look forward to working with the FDA to bring the potential of a dual Immuno-Oncology therapy to these patients for the first time.”
Trial Results
FAILED TRIAL: Ph III TreeTopp trial of Varlitinib failed to meet primary endpoint in Biliary Tract cancer patients
The topline data from Ph III TreeTopp ((TREatmEnT OPPortunity with varlitinib in biliary tract cancer) showed that primary endpoints of PFS improvement or ORR did not meet the pre-specified significance level in previously-treated BTC patients, when assessed by RECIST criteria.   
New positive data announced from Ph II trial of onvansertib + Zytiga® (abiraterone acetate) /prednisone in mCRPC patients
"The new data shared today builds upon the encouraging clinical response seen to date when onvansertib is added to treatment in patients who have developed resistance to androgen receptor signaling inhibitor (ARSi), Zytiga®," said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. "Of particular significance are the positive results we are observing in patients who harbor the highly aggressive, resistant variant of the androgen receptor (AR-V7). These patients are resistant to ARS inhibitors including Zytiga® and Xtandi® (enzalutamide - Pfizer) and their therapeutic options are not only limited, but often ineffective. We believe the addition of onvansertib has the potential to deliver transformative benefit to patients with mCRPC by extending the duration of response to treatment with ARS inhibitors."
New positive Ph II GBM data of AIVITA’s patient-specific immunotherapy AV-GBM-1 announced
AIVITA Chief Scientific Officer Gabriel I. Nistor, M.D. acknowledged that the immune response data is highly encouraging. “Once the trial is complete, we’re looking forward to determining the correlation between immune responses and clinical outcome as we previously did in patients with metastatic melanoma treated with a similar patient-specific vaccine,” said Dr. Nistor.
Click Here for more Trial Results
Trial Status/Progress
Ph II Codex trial of Inodiftagene Vixteplasmid in NMIBC patients discontinued; company focuses on advancing pan-RAS inhibitor program
“We are disappointed by the results of the Codex study, as we recognize the urgent need for new effective therapies for patients with non-muscle-invasive bladder cancer. We thank the patients, caregivers and investigators involved in our clinical study,” said Frank Haluska M.D., Ph.D., President and Chief Executive Officer of Anchiano.
ATIR101’s development to be discontinued along with ongoing Ph III trial; company to focus solely on development of Natural Killer (NK) Cell therapeutics
Arthur Lahr, CEO of Kiadis Pharma commented, “We believe that our proprietary NK-cell therapy platform has broad potential as stand-alone or adjunctive treatments for patients with both liquid and solid tumors. Our off-the-shelf NK-cell platform is based on NK-cells from unique universal donors, expanded and activated with our PM21 particle technology, to make our NK-cell therapy products rapidly and economically available for patients across a potentially broad range of indications. The proof-of-concept trials for our NK pipeline programs, in which 38 patients have been treated, is very promising and was the basis for our acquisition of Cytosen Therapeutics, Inc. earlier this year. To confirm findings from these trials, we will start two Phase 1/2 clinical trials in 2020. We believe that investing in our NK platform and rapidly advancing development of our off-the-shelf and haplo donor derived NK-cell therapies in solid and liquid tumors will bring value to patients and our investors.” 
Click Here for more Trial Status/Progress
MedNess Business
Onco-News

Gossamer Bio and Merck collaborate to evaluate GB1275 and Keytruda® combination for advanced solid tumor
Gossamer Bio and Merck & Co., Inc have entered into a collaborative agreement to conduct a Phase 1/2 clinical trial for a combination therapy of Gossamer’s GB1275 and Merck’s anti-PD1 therapy Keytruda®. GB1275 targets the immunosuppressed myeloid cell receptor CD11b receptor often expressed in the tumor microenvironment, which has shown promising preclinical results, gaining orphan drug designation from FDA for the treatment of pancreatic cancer. The announcement comes almost a week after Merck’s collaboration with Promega towards developing the microsatellite instability (MSI) technology as a companion diagnostic with Keytruda®. 
“We are very excited to collaborate with Merck, an established leader in cancer immunotherapy, on our fourth clinical asset and first oncology agent, GB1275, as we work to improve the lives of cancer patients,” said Sheila Gujrathi, M.D., Chief Executive Officer of Gossamer.
Bio-Pharma and MedTech

FDA approves Adakveo® (Crizanlizumab) from Novartis to tackle pain crisis in sickle cell disease
Novartis announced the approval of Adakveo® monoclonal antibody therapy by the FDA to reduce the frequency of pain crises in patients older than 16 years suffering from sickle cell disease. Adakveo® binds to the cell adhesion protein, P-selectin, on the surface of activated endothelial cells and platelets that have been linked to vaso-occlusive crisis. The randomized, placebo-controlled SUSTAIN trail lasting for 52-weeks show a 45% reduction in pain crises and decreased median annual rate of days hospitalized from 6.87 to 4. The medicine is expected to be in the market in coming weeks.
“The approval of Adakveo marks a new era in the treatment of sickle cell disease, a genetic condition that places an extraordinary burden of unpredictable pain crises on patients and their families,” said Susanne Schaffert, PhD, President, Novartis Oncology. “The stories we have heard from patients about their sickle cell pain crises are devastating. We are pleased to help reimagine medicine together with the sickle cell community and offer new hope for fewer VOCs.”

Roche acquires Promedior Inc. for $390 million expanding its fibrotic disease pipeline
Roche has agreed to pay $390 million upfront to acquire Boston-based Promedior Inc. with a combined upfront and milestone based payment of $1.4 billion. The startup focuses on fibrosis in various organs and currently has one candidate, PRM-151, for idiopathic pulmonary fibrosis ready for phase 3 trial. Additional pipeline includes candidates for myelofibrosis, NASH / liver fibrosis, fibrotic kidney disease and fibroproliferative retinal diseases in early-to-mid stage trials. 
"We are excited to combine Promedior's portfolio with our drug development capabilities to further advance PRM-151 in fibrotic diseases, including IPF and MF,” added James Sabry, M.D., Ph.D., global head of Roche Pharma Partnering. “With our proven track record in IPF with Esbriet  as well as in hematological cancers, we are well-positioned to leverage our clinical and commercial expertise to bring PRM-151 to patients as fast as possible.”
Click Here for more mergers and acquisitions 
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Mayur Vadhvani, PhD
Business News
Abhi Dey
Consulting Editor
Arundithi Ananthanarayanan
I-cube
Nisha Peter, PhD
Managing 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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