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MedNess: bite-size biopharma and medtech news

Onco-This-Week
2nd July , 2019
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MedNess This Week
Highlights
Drug Approvals
FDA approves daratumumab in combination with lenalidomide and dexamethasone in 1L ASCT-ineligible MM patients based on Ph III MAIA results
“The combination of lenalidomide and dexamethasone is broadly used by newly diagnosed patients with multiple myeloma ineligible for ASCT in the United States. We are extremely pleased that physicians can now offer their patients the option to add DARZALEX to this regimen in the U.S.,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
FDA approves bevacizumab’s  biosimilar, ZIRABEV™ (bevacizumab-bvzr), in mCRC, mNSCLC, rGBM, mRCC, and persistent, recurrent or metastatic cervical cancer
“Biosimilars like ZIRABEV can help increase access to impactful therapies, driving market competition that may ultimately lower costs and help address the diverse needs of patients living with cancer,” said Andy Schmeltz, Global President, Pfizer Oncology. “We are proud to add ZIRABEV to our growing oncology portfolio for U.S. patients living with a wide variety of tumor types.”
Regulatory News
CHMP recommends EU approval of Atezolizumab + nab-paclitaxel in 1L, PD-L1+ve, mTNBC patients based on Ph III IMpassion130 trial results
“This CHMP recommendation marks a breakthrough in the treatment of triple-negative breast cancer, an aggressive type of breast cancer with high unmet medical need,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “With today’s announcement, we hope that people living with PD-L1-positive metastatic triple-negative breast cancer in Europe will soon have a new treatment option with the Tecentriq combination.”
INDA submitted to initiate a Ph I trial of STING agonist SB 11285 in patients with advanced solid tumors
“STING agonists have the potential to become an important immunotherapeutic approach for the treatment of multiple cancers. The availability of an intravenously-administered STING agonist could significantly expand the number of cancers and patients in which such an immunotherapeutic agent could be utilized. Importantly, this approach may be able to overcome the need for intra-tumoral administration observed with the first-generation STING agonist approaches,” said Jason Luke, M.D., Associate Professor of Medicine and Director of the Cancer Immunotherapies Center at the UPMC Hillman Cancer Center.
Onco-Trial Results
Durvalumab meets primary endpoint of OS improvement at interim analysis in the Ph III CASPIAN trial in 1L extensive-stage SCLC
José Baselga, Executive Vice President, Oncology R&D said: “The Phase III CASPIAN results offer new hope for patients who are facing the devastating diagnosis of small cell lung cancer, and for whom new medicines are urgently needed. This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options.”
Positive safety, tolerability and preliminary efficacy data announced from the full patient cohort of Ph Ib trial of TAR-200 in MIBC patients, neoadjuvant to radical cystectomy
“The TAR-200-101 study has revealed exciting results in patients with muscle invasive bladder cancer,” said Siamak Daneshmand, M.D., Director of Urologic Oncology at the USC Institute of Urology, and principal investigator of the study. “Such evidence of response, while early, may enable definitive treatment in patients currently unfit for curative intent therapy, including treatment with checkpoint inhibitors. Moreover, TAR-200 may also ultimately enable organ preservation strategies in lieu of radical cystectomy in patients who are unfit or unwilling to undergo bladder removal.”
Onco-Trial Status/Progress
Development of IMGN779 to be discontinued in R/R CD33-positive AML patients among other changes in Immunogen future plans
“This was an extremely difficult decision for the Board, as we believe deeply in the therapeutic promise of ADCs, the Company’s science, and its people,” said Steve McCluski, ImmunoGen’s Chairman of the Board. “These are, however, the right steps to take to bring mirvetuximab to patients and offer the best opportunity to capture long-term value for our shareholders, whom we thank for their support.”
Advaxis, Inc. to close Ph III AIM2CERV trial of axalimogene filolisbac (AXAL) in high-risk locally advanced cervical cancer; to increase focus on neoantigen-directed immunotherapies
“We remain firmly committed to our Lm Technology™ platform, including our personalized and off-the-shelf approaches for neoantigen-directed therapies, and the development of AXAL against HPV-related cancers,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “While closing the AIM2CERV trial was a difficult decision due to the efforts of many individuals including the investigators and patients, the delays we incurred as a result of the recent FDA partial clinical hold and the estimated cost and time to completion for AIM2CERV led us to believe the best path forward for the company is to focus on our neoantigen programs. We believe this increased focus will enable a quicker and more cost-effective approach to demonstrate the strength and versatility of our Lm platform, thereby enhancing shareholder value.”
Click Here for more Progress/status of ongoing trials
Diagnostic Assays
MHLW granted an additional approval for FoundationOne® CDx Cancer Genomic Profile as a companion diagnostic for entrectinib in NTRK fusion +ve solid tumor patients
“The conventional concept of cancer treatment focuses on the site where the cancer started. However, it is drastically changing with the emergence of a completely new approach called tumor agnostic treatment; an approach which targets genomic mutations that drive cancers instead of the tumor location in the body. We are proud of the MHLW approval of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for Rozlytrek which represents this new tumor agnostic treatment approach,” said Dr. Minoru Watanabe, Chugai’s Vice President, Head of Foundation Medicine Unit. “A comprehensive genomic profiling test is especially beneficial in identifying rare gene mutations expressed in multiple cancer types, including NTRK gene fusions. Chugai will further strive to provide services to help physicians’ swift and appropriate decision making in order to realize patient-centric healthcare.”
MedNess Business
Onco-News
SpringWorks Therapeutics and GlaxoSmithKline to evaluate GSI nirogacestat + BCMA-targeting ADC belantamab mafodotin (formerly GSK2857916) in Ph Ib trial in RRMM patients
“While significant advances have been made in treating multiple myeloma over the past decade, a significant unmet need remains for patients who have relapsed or are refractory to available treatments,” said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. “We are delighted to enter into this agreement with GlaxoSmithKline, who also invested in our recent Series B financing, and we look forward to exploring the potential benefit of nirogacestat and belantamab mafodotin for multiple myeloma patients. With this collaboration, we are pleased to further expand on our strategy in building our targeted oncology portfolio with another industry leader.”
TILT Biotherapeutics, Merck and Pfizer to evaluate armed oncolytic virus, TILT-123, with avelumab in patients with solid tumors refractory to routine modalities
“We are pleased to initiate a collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to translate our findings into patients. Preclinical results with TILT®-technology and anti-PD(L)1 agents suggest immune activation and efficacy in certain animal models”, explains Akseli Hemminki (MD, PhD, eMBA), CEO and Founder of TILT Biotherapeutics.
Intensity Therapeutics and Merck to evaluate INT230-6 + pembrolizumab in Ph I/II trial in advanced solid tumor pts including pancreatic, bile duct, squamous cell and non-MSI high colon cancers
“Our research suggests our product, INT230-6, which enables improved recognition of cancer by the immune system, may exhibit additional effect when combined with anti-PD-1 antibodies,” said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. “We are excited to be working with Merck, one of the world’s leading cancer immuno-oncology companies, on our current Phase 1/2 clinical trial to explore the combination of INT230-6 and KEYTRUDA® in cancers with high unmet medical need. We are looking forward to initiating the combination portion of our program in the second half of this year.”
BioPharma and MedTech

Century Therapeutics launch backed by $250M from Bayer for cell therapy platform
Century Therapeutics exited the stealth mode with $250M financial support from Bayer, Versant Ventures and Fujifilm Cellular Dynamics Inc (FCDI) to develop allogenic cell therapies into the clinic. While other allogenic cell therapies work on non-renewable donor cells, Century's technology utilizes induced pluripotent stem cells (iPSCs) with self-renewing capabilities. These cells undergo multiple rounds of cellular engineering to create master cell banks which are then differentiated into immune effector cells, thereby generating large supply of homogenous off-the-shelf products. Using this technology, Century will focus on blood cancers and solid tumors in humans.

 

Bracco Imaging acquires Blue Earth Diagnostics for $450M

The Italian multinational Bracco has acquired the molecular PET agent developer Blue Earth for $450M boosting its diagnostic portfolio. The acquisition includes Blue Earth's first approved and commercialized molecular imaging agent, Axumin, that helps identify recurrent prostate cancer. This acquisition bolsters Bracco's portfolio into diagnostics alongside its currently existing market share in X-ray, CT, MRI, interventional radiology, cardiac catheterization and contrast-enhanced ultrasound. Hours before the acquisition announcement, Ble Earth detailed the clinical proof-of-concept data using a radiohybrid Prostate Specific Membrane Antigen-targeted compund (18F-rhPSMA7).

MODAG receives €12M series A financing to develop treatment for Parkinson's disease and Multiple System Atrophy (MSA)

The German biotech MODAG came out of stealth mode  and raised €12M to advance the clinical development of lead candidate anle138b for MSA, a rare neurodegenerative disorder characterized by tremors and certain symptoms of parkinsonian syndrome. Anle138b is a small molecule inhibitor of alpha-synnuclein oligomers that leads to neuronal toxicity. Initially supported by Michael J Fox Foundation for early stage and preclinical development, MODAG has secured the funds to generate the proof-of-concept studies to target alpha-synnucleopathies in MSA.
Click Here to know more about  M&A – Fund raising – Investments and more..
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Mayur Vadhvani, PhD
Business News
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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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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