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MedNess: bite-size biopharma and medtech news

Onco-this-Week
16th July, 2019
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MedNess This Week
Highlights
Regulatory News
FDA accepts CD38 inhibitor Isatuximab's BLA for review in RRMM patients based on Ph III ICARIA-MM trial results; PDUFA: Apr 2020
Isatuximab also received orphan drug designation (ODD) in this setting from both the FDA and the EMA. Also, in 2Q 2019 the EMA accepted for review the MAA for Isatuximab in relapsed/refractory multiple myeloma patients.
FDA grants CLR 131 Fast Track Designation in R/R DLBCL patients based on Ph II CLOVER-1 trial data
“We are pleased to receive FDA’s Fast Track Designation for CLR 131.  This designation supports our efforts to more rapidly provide a new therapeutic option for patients with relapsed or refractory DLBCL, a disease that typically has a very poor prognosis and low rates of survival,” said James Caruso, president and CEO of Cellectar. “As announced last year, data from the DLBCL cohort in our ongoing CLOVER-1 trial showed an encouraging 33% overall response rate at the time of the interim assessment. Patients prior to the interim assessment received a single 25.0 mCi/m2 dose of CLR 131. Dosing in the Phase 2 CLOVER-1 study has increased, and patients are now receiving 37.50 mCi/m2 fractionated in two administrations of CLR 131. We are optimistic that CLR 131 has the potential to provide a meaningful treatment option for these patients and look forward to additional data in 2019.”
Onco-Trial Results

New clinical data announced from Ph II brain cancer trial of autologous Tumor Associated Antigens (AV-GBM-1) + concurrent CRT in 1L GBM patients
“The data indicate that all mechanistic pathways with anti-tumoral effects are being activated in the surviving melanoma patients and seven out of eight of the treated glioblastoma patients, in particular the cytotoxic Th1-Th17 response and an immunoglobulin Th2 response,” said Dr. Gabriel Nistor, AIVITA’s Chief Science Officer. “It just makes sense; this is how the immune system fights cancer.”
Onco-Trial Status/Progress
Ph Ib trial of TAR-200 + nivolumab initiated in MIBC patients
"This clinical trial will be the first to evaluate the combination of the locally-administered TAR-200 system with a systemic PD-1 checkpoint inhibitor, approved for previously treated adults with advanced bladder cancer," said Christopher J. Cutie, M.D., Chief Medical Officer of TARIS. "We are eager to evaluate the potential antitumor and immunologic synergy of this product combination administered prior to surgery."
Patient enrolment initiated in Ph I/II tissue-type agnostic basket trial of PKC inhibitor IDE196 in solid tumors patients with GNAQ or GNA11 mutations
"We are delighted to announce our first patient dosing for IDE196 in our tissue type agnostic GNAQ and GNA11 basket trial, and the opportunity to advance IDE196 in its dose escalation with the goal of enabling the optimal dose selection for the Phase 2 portion of the trial," said Julie Hambleton, M.D., Chief Medical Officer, Head of Development at IDEAYA Biosciences.
MedNess Plus
“Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps,” said Sally Seymour, M.D., Director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids.”
FDA approves Soliris for the treatment of neuromyelitis optica spectrum disorder in adult patients
“Soliris provides the first FDA-approved treatment for neuromyelitis optica spectrum disorder, a debilitating disease that profoundly impacts patients’ lives,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This approval changes the landscape of therapy for patients with NMOSD. Having an approved therapy for this condition is the culmination of extensive work we have engaged in with drug companies to expedite the development and approval of safe and effective treatments for patients with NMOSD, and we remain committed to these efforts for other rare diseases.”
Novartis highlights data from the study of Aimovig showing a reduction in acute migraine medication days by half
Novartis recently announced positive data from the study of Aimovig (from the active treatment phase, ATP) in reducing the monthly migraine days, migraine-specific medication days for patients with episodic migraine. The data for STRIVE Phase III clinical study will be presented at the European Academy of Neurology annual meeting in Oslo, Norway. The data from this study will further ratify the claims of safety and efficacy for Aimovig in treating patients with migraine who have failed prior preventive treatments. In the U.S. Aimovig is being co-commercialized by Novartis and Amgen. Other than Japan, Novartis has the rights for commercialization of Aimovig in the rest of the world.
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MedNess Business
Onco-News

Forty Seven, Inc. and Ono Pharmaceutical to develop, manufacture and commercialize 5F9 in Japan, South Korea, Taiwan and select countries in Southeast Asia

Forty Seven, Inc., a clinical stage immune-oncology company, announced an exclusive license agreement with Ono Pharmaceuticals for the development, manufacture and commercialization of 5F9, Forty Seven’s monoclonal antibody targeting CD47. According to the agreement, Forty Seven will receive an upfront payment of $15.8M from Ono and additional $104M if the development and commercialization milestones are achieved by Ono, in addition to the tiered royalties on future sales of the product in Japan, South Korea, Taiwan and ASEAN countries.

 

MacroGenics and I-Mab to develop and commercialize Enoblituzumab in Greater China

MacroGenics, Inc and I-Mab Biopharma have signed in for an exclusive collaboration and license agreement to develop and commercialize enoblituzmab, an immune-optimized investigational monoclonal antibody targeting B7-H3 using MacroGenics’ proprietary Fc Optimization technology platform. Under the agreement, MacroGenics is expected to receive an upfront payment of $15M with additional development and regulatory milestone payments of up to $135M. I-Mab, in addition, will pay a tiered royalty on annual sales in its territories.
BioPharma and MedTech

Orchestra Biomed bags $34M series B-1 to advance development of devices for cardiovascular therapies

After closing deal with Terumo last month for developing and commercializing its sirolimus-eluting balloon for cardiovascular interventions, Orchestra Biomed has raised another $34M in series B-1 preferred stock financing. Orchestra may further receive $57M in follow-on investments from existing shareholders. The funds will be used to push the development of Orchestra’s lead and pipeline products including BackBeat Cardiac Neuromodulation Therapy (CNT) for hypertension. The funds will also be utilized for advancing the existing partnership with Terumo for development and commercialization of Virtue Sirolimus-eluting balloon.

BioNTech raises $325M in series B financing to advance immune-oncology pipeline

BioNTech SE, a clinical stage biotechnology company focused on immune-oncology therapies, has raised $325M in series B of financing round, the largest single private funding round for biotechnology company. The funding follows the series A of $270M that was announced in January 2018. The current funding will support the advancement of BioNTech’s therapeutics pipeline and manufacturing infrastructure.
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Editors' Desk
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The sponsors do not have any influence on the nature or kind of the news/analysis reported in Onco-this-Week. 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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