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MedNess: bite-size biopharma and medtech news

26th November, 2019
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Drug Approval
FDA approved Calquence (acalabrutinib) for CLL or SLL patients based on positive results from interim analyses of Ph III ELEVATE-TN (in 1L CLL patients) and ASCEND (in 2L+ CLL patients)
Dave Fredrickson, Executive Vice President, Oncology Business Unit said: “With over 20,000 new cases anticipated this year in the US alone, today’s approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering outstanding efficacy and a favourable tolerability profile. The chronic lymphocytic leukaemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment.”
European Marketing Authorization granted to DARZALEX® (Daratumumab) + Lenalidomide and Dexamethasone in 1L Multiple Myeloma patients based on Phase III MAIA trial
“We are pleased that with this approval, patients in the European Union newly diagnosed with multiple myeloma who are not candidates for transplant will now have two potential options for treatment with DARZALEX containing regimens. We look forward to seeing the combination therapy of DARZALEX with lenalidomide and dexamethasone launched in Europe,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
European Commission approved KEYTRUDA (pembrolizumab) in 1L, PD-L1+ve SCCHN patients based on findings from the pivotal Ph III KEYNOTE-048 trial
“This disease is especially debilitating since it can be highly visible and affect a patient’s appearance and their daily functions, such as eating and speaking,” said Professor Kevin Harrington, investigator for KEYNOTE-048, professor of biological cancer therapies at The Institute of Cancer Research, London, and consultant clinical oncologist at The Royal Marsden NHS Foundation Trust. “Considering the great need for new treatment options, we are encouraged by today’s KEYTRUDA approval in Europe, which will allow certain patients to be treated with immunotherapy earlier in the course of their treatment.”
Regulatory News
Ongoing tafasitamab Ph III B-MIND trial successfully passed the pre-planned, event-driven interim analysis for futility
"We are very pleased with the IDMC recommendation and see it as an important step in the clinical development of tafasitamab", said Dr. Malte Peters, Chief Development Officer of MorphoSys. "DLBCL is a difficult to treat disease and has a high unmet medical need, so new treatment options are highly needed. Independent of B-MIND, we are on track to complete our BLA submission to the U.S. FDA for tafasitamab in combination with lenalidomide by the end of 2019 based on the previously reported encouraging results from the L-MIND and Re-MIND clinical studies."
Trial Results
SNO 2019: Updated clinical results from Ph IIb trial of MDNA55 in rGBM patients presented
"In this trial, particularly for patients with IL4R over-expression, a prognostic factor that is known to contribute to poor survival, it is gratifying to see that a single treatment with MDNA55 is able to produce impressive survival and tumor control."  stated Dr. Sampson. "By combining precise drug delivery and a targeted therapy, MDNA55 could potentially provide new hope to a large majority of brain cancer patients expressing an important immunotherapeutic biomarker."
Statistically significant OS and PFS reported from Ph III IMbrave150 trial of Tecentriq® (atezolizumab) + Avastin® (bevacizumab) in 1L HCC patients
“For the first time in a decade, we are seeing a treatment that has improved overall survival for people with unresectable hepatocellular carcinoma compared with the current standard of care,” said Levi Garraway, M.D., Ph.D, Chief Medical Officer and Head of Global Product Development. “Tecentriq in combination with Avastin could transform the treatment of this aggressive disease, and we are working closely with global health authorities in the hope of bringing this treatment option to patients as soon as possible.”
FAILED TRIAL: Ph III CheckMate-915 trial of Opdivo (nivolumab) + Yervoy (ipilimumab) versus Opdivo alone failed to meet co-primary endpoint of RFS improvement in surgically resected melanoma patients
  • Patient pool: Patients who have had a complete surgical removal of stage IIIb/c/d or stage IV (no evidence of disease) melanoma
  • Treatment arms: Opdivo 240 mg intravenously every two weeks and Yervoy 1 mg/kg every six weeks or Opdivo 480 mg every four weeks for one year for the adjuvant treatment
  • Outcome: Statistically significant benefit not reached for the co-primary endpoint of recurrence-free survival (RFS) in patients whose tumors expressed PD-L1 <1%.
  • Next steps: Data Monitoring Committee recommended that the study continue unchanged.
Click Here for more Trial Results
Trial Status/Progress
Ph III MOMENTUM clinical trial initiated in patients with Myelofibrosis
"I am pleased to act as Chief Investigator for this important global trial for the myelofibrosis patient community," said Dr. Srdan Verstovsek, MD, PhD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas. "JAK inhibitors remain the cornerstone of myelofibrosis treatment but new options in this class are needed for the majority of patients who have difficulty tolerating the currently approved agents due to the cytopenias they can exacerbate or induce. Momelotinib could become a suitable alternative for many patients previously treated with a JAK inhibitor due to its ability to positively address all three hallmarks of myelofibrosis - symptoms, anemia and an enlarged spleen. Critically, momelotinib has consistently demonstrated positive anemia benefits in its prior clinical trials. This anemia benefit is biologically-driven, via potent inhibition of the ACVR1/hepcidin axis, a mechanism that is unique in the JAK inhibitor class."
Neon Therapeutics announced new strategic focus on novel T Cell Programs
“Prioritizing development of novel T cell therapies will leverage our years of expertise and learnings in pioneering neoantigen science, while positioning Neon to best deliver new therapies that could potentially improve patient outcomes and bring value to shareholders. The strategic restructuring will enable us to focus resources to execute on this vision. We acknowledge this decision impacts many talented employees who helped build Neon into a leader in neoantigen-based-therapies and we are grateful for their many contributions,” said Hugh O’Dowd, Neon’s Chief Executive Officer.
Click Here for more Trial Status/Progress
MedNess Plus
FDA approves Givlaari as the first treatment of a genetic disorder, acute hepatic porphyria
“This buildup can cause acute attacks, known as porphyria attacks, which can lead to severe pain and paralysis, respiratory failure, seizures and mental status changes. These attacks occur suddenly and can produce permanent neurological damage and death,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Prior to today’s approval, treatment options have only provided partial relief from the intense unremitting pain that characterizes these attacks. The drug approved today can treat this disease by helping to reduce the number of attacks that disrupt the lives of patients.”
“Adakveo is the first targeted therapy approved for sickle cell disease, specifically inhibiting selectin, a substance that contributes to cells sticking together and leads to vaso-occlusive crisis,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Vaso-occlusive crisis can be extremely painful and is a frequent reason for emergency department visits and hospitalization for patients with sickle cell disease.” “Hope has never been higher for people living with sickle cell disease and their families and supporters, with a pipeline of new treatments on the horizon, like the one being approved today, and several initiatives underway to better utilize current tools in the battle against the painful and deadly blood disorder,” said Acting FDA Commissioner Adm. Brett P. Giroir, M.D. “The opportunity before us in the coming months and years is profound and historic.”
FDA approves XCOPRI tablets for the treatment of partial-seizures in adults
“XCOPRI is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Patients can have different responses to the various seizure medicines that are available. This approval provides an additional needed treatment option for people with this condition.”
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MedNess Business
Onco-News

Anixa Biosciences and Idaho Urologic Institute collaborate for CcheckTM prostate cancer study
Anixa Biosciences and Idaho Urologic Institute (IUI) announced a collaboration for the early detection of prostate cancer through the CcheckTM cancer detection technology. CcheckTM is the cancer detection platform that uses a patient's blood to determine their cancer status thereby eliminating the need for biopsy. IUI will support the study by providing the patient’s blood samples for Anixa’s prostate cancer study.
Dr. Amit Kumar, Chief Executive Officer of Anixa, stated, “We are pleased to have IUI join our expanding group of Cchek™ collaboration partners. Our large and growing team of influential collaborators has been key to the development of our artificial intelligence driven liquid biopsy for early cancer detection. We look forward to IUI’s participation as we continue the clinical validation phase of the Cchek™ Prostate Cancer Confirmation test, in preparation for commercial launch later this year.”

Harpoon Therapeutics and AbbVie collaborate to expand Harpoon’s BCMA-targeting platform
Harpoon Therapeutics and AbbVie have set up a collaboration for AbbVie to license worldwide Harpoon’s HPN217, the B-cell maturation antigen (BCMA)-targeting Tri-Specific T cell Activating Construct (TriTAC®) in addition to expanding their existing discovery for up to six additional targets. The TriTAC® platform targets both solid and blood tumors by producing T cell engagers. Under the license and options agreement, Harpoon will develop HPN217 through clinical phase 1/2 after which AbbVie will retain the option to license the program. Harpoon could receive up to $510 million in upfront and milestone based payments for the license agreement. For the expanded discovery collaboration agreement for up to six targets, Harpoon will receive up to $310 million in upfront, development, commercialization and milestone payments. 
“Harpoon has built a unique and proprietary biologics platform that utilizes the cancer patient’s own immune system to attack cancer. HPN217, targeting BCMA, is poised to advance to clinical development for the treatment of multiple myeloma”, stated Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon. “We believe AbbVie is the ideal partner for Harpoon to support the advancement of our BCMA program given the commercial focus of AbbVie in the treatment of this cancer. In addition, we look forward to expanding our discovery collaboration to include up to six additional molecular targets.” 
Bio-Pharma and MedTech

Novartis buys The Medicines Company for $9.7 billion to expand its cardiovascular portfolio
Novartis announced the acquisition of The Medicines Company for $9.7 million including the clinical programs ORION-9, 10 and 11 for inclisiran being developed for patients with atherosclerotic cardiovascular disease and familial hypercholesterolemia. Inclisiran is the cholesterol-lowering small-interfering RNA (siRNA) therapy currently in phase III clinical development which received an orphan drug designation by the FDA in January 2018. According to the agreement, Novartis will offer $85 per share through a subsidiary to The Medicines Company which is expected to close in the first quarter of 2020. 
Novartis CEO Vas Narasimhan said: “We are excited about entering into an agreement to acquire The Medicines Company as inclisiran is a potentially transformational medicine that reimagines the treatment of atherosclerotic heart disease and familial hypercholesterolemia. With tens of millions of patients at higher risk of cardiovascular events from high LDL-C, we believe that inclisiran could contribute significantly to improved patient outcomes and help healthcare systems address the leading global cause of death. The prospect of bringing inclisiran to patients also fits with our overall strategy to transform Novartis into a focused medicines company and adds an investigational therapy with the potential to be a significant driver of Novartis’ growth in the medium to long term.”

Ferring Pharma and Blackstone Life Sciences create new subsidiary with $570 million to develop gene therapies for bladder cancer
Ferring Pharmaceuticals and Blackstone Life Sciences have joined hands to invest $570 million into a new gene therapy subsidiary FerGene, to potentially commercialize nadofaragene firadenovec (rAd-IFN/Syn3) initially in the USA. It is an adenovirus vector based gene therapy to express gene interferon alfa-2b, resulting in high secretion of cancer fighting protein. Currently in phase III, the therapy has already received a Breakthrough Therapy designation from FDA. Additionally, the Biologics License Application (BLA) has been accepted for filing and granted a priority review. The subsidiary will be created by investment of $400 million from Blackstone Life Sciences and $170 million by Ferring. 
“Through FerGene, Blackstone and Ferring’s goal is to successfully commercialize and further develop this adenovirally mediated interferon alfa-2b gene therapy, a potential breakthrough treatment for high-grade, BCG unresponsive, non-muscle invasive bladder cancer patients,” said Paris Panayiotopoulos, Blackstone Life Sciences Managing Director.
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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