View this email in your browser

MedNess: bite-size biopharma and medtech news

Onco-This-Week
28th May , 2019
Subscribe here
MedNess This Week
Highlights
Drug Approvals
“Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer,” said Bill Doyle, Novocure’s Executive Chairman. “FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure. We are thankful for the patients, caregivers and health care providers who partnered with us to make this possible.”
FDA approves first PI3K inh Alpelisib + Fulvestrant in HR+ HER2neg PI3KCA-mutated breast cancer patients based on doubled PFS data in SOLAR-1 trial
"The FDA approval of Piqray, which was discovered at the Novartis Institutes for BioMedical Research, marks the first ever treatment specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation. We are proud to offer a new treatment option that specifically addresses the needs of the patients living with this mutation," said Susanne Schaffert, PhD, CEO, Novartis Oncology. "We are grateful to our researchers' bold and unrelenting pursuit of a first-in-class treatment for this incurable disease, and to the patients, investigators and administrators who participated in the clinical trials leading to this remarkable milestone."
Regulatory News
Breakthrough Therapy Designation for LN-145 for chemo-refractory cervical cancer patients
“We are very excited that the FDA has granted LN-145 in advanced cervical cancer Breakthrough Therapy designation. Cervical cancer patients who have progressed on or after chemotherapy have limited treatment options. We hope to bring LN-145 to these patients as quickly as possible,” commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance. “The designation allows us to expedite our development program through more frequent interactions with the FDA and provides eligibility for rolling review and priority review.”
Onco-Trial Results

Ph III CRC BEACON trial of BRAFTOVI triplet (encorafenib, binimetinib, cetuximab) meets primary endpoints of OS/ORR in 2L/3L BRAFV600E-mutant mCRC patients
"The BEACON CRC trial is the first Phase 3 trial in patients with BRAFV600E-mutant mCRC and these results show a significant improvement compared to available standard of care options for this patient population," said Scott Kopetz, M.D., Ph.D., FACP, Associate Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. "Given that there are no therapies currently FDA-approved for this patient population, I believe the results of the BEACON CRC trial will be practice-changing."
Encouraging interim data announced from ongoing Ph II KEYNOTE-890 trial of TAVO + Pembrolizumab in heavily pretreated, chemo/RT-refractory mTNBC patients
"These interim data are impressive, especially when considering that all of the patients received numerous prior rounds of chemo/radiation with no success, and the safety profile associated with this platform continues to be unparalleled.  Metastatic TNBC is a heterogeneous cancer with a poor prognosis where less than five percent of pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint treatments," explained Alain Algazi, M.D., Associate Professor of Clinical Medicine at UCSF and Clinical Strategic Advisor to OncoSec. "Therefore, the marked synergy shown in these patients adds even more support for our earlier findings demonstrating that TAVO primes the tumor microenvironment, dramatically improving the clinical results that would have been anticipated with PD-1/PD-L1 checkpoint treatment alone. The combination of TAVO and KEYTRUDA represents a highly promising new therapeutic approach for TNBC and warrants expedited evaluation."
Onco-Trail Status/Progress
Targovax to not pursue TG program on a stand-alone basis and to allocate all resources on the ONCOS oncolytic virus program
Øystein Soug, CEO of Targovax, said: “We are proud to have brought both the TG and ONCOS programs to an advanced development stage. We have a leading role in oncolytic viruses and to maintain our position we wish to prioritize our resources. As a consequence, we will seek alternative ways to progress and capture value from TG. I firmly believe that the Company will be strengthened by a sharpened focus on ONCOS, and that this move significantly increases our chance of success.”
First patient enrolled in Ph Ib/II SMARTPLUS-106 trial of IAP inhibitor Debio 1143 + Nivolumab in PD-(L)1-failed solid tumors (SCLC/SCCHN) patients
“As IAP inhibition has shown synergistic potential in combination with immunotherapeutic agents, this study is of critical importance to document the clinical efficacy of this new treatment combination in patients not responding to ICIs.”– Angela Zubel, Chief Development Officer, Debiopharm International SA.
Click Here for more Onco-Trial Results and Progress/status of ongoing trials
MedNess Plus
“Today’s approval marks another milestone in the transformational power of gene and cell therapies to treat a wide range of diseases,” said Acting FDA Commissioner Ned Sharpless, M.D. “With each new approval, we see this exciting area of science continue to move beyond the concept phase into reality. The potential for gene therapy products to change the lives of those patients who may have faced a terminal condition, or worse, death, provides hope for the future. The FDA will continue to support the progress in this field by helping to expedite the development of products for unmet medical needs through the use of review pathways designed to advance innovative, safe and effective treatment options.”
“Most children who have VTE (Venous thromboembolism) are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. Given the unmet need, we granted the Fragmin application priority review and today we are approving it as the first anticoagulant (blood thinner) indicated for pediatric patients. We remain committed to advancing treatments for children with unmet medical needs.”
FDA approves the marketing of the first diagnostic test for the detection of Zika virus antibodies
"At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using our emergency use authorities,” said FDA Acting Commissioner Ned Sharpless, M.D. “Today’s marketing authorization is a great demonstration of the FDA’s work to protect the public health in emergency response situations. We ensured there were tests made available quickly under EUA, but we continued to work with diagnostic manufacturers to take the next step of ensuring products were FDA reviewed for safety and effectiveness and authorized under our traditional premarket authorities.”
Click Here for more on MedNess Plus...
Diagnostic Assays
Target Selector™ Multi-Gene liquid biopsy panel launched for lung cancer
"We are very pleased to launch our first multi-gene liquid biopsy panel to physicians and researchers in both academic centers and the pharmaceutical industry," said Michael Nall, Biocept's President and Chief Executive Officer. "This new solution makes Biocept the only commercial liquid biopsy company that can offer customers the flexibility to order either a customized single biomarker assay or a larger NGS-based liquid biopsy test panel for use when more comprehensive testing is desired. This new offering complements our existing Target Selector™ testing platform, which focuses on delivering actionable and cost-effective biomarker information to address needs of physicians, healthcare systems and payors as they develop personalized treatment protocols for patients diagnosed with cancer."
MedNess Business
Onco-News
Merck to acquire Peloton Therapeutics for 1.1B, bolstering oncology pipeline by adding Ph III RCC-ready HIF-2alpha-targeting drug PT2977
Merck is set to acquire Peloton Therapeutics for $1.1B upfront with additional $1.2B in milestone-based payments. The deal was finalized days before Peloton was set to go public to raise $150M or more for late-phase trial of HIF-2α inhibitor PT2977 in metastatic renal cell carcinoma cancer patients. “This acquisition exemplifies Merck’s strategy to pursue novel therapeutic candidates based on exceptionally promising and innovative research” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Peloton scientists have applied their unique expertise in HIF-2α biology to develop PT2977, which has already shown intriguing activity in the treatment of renal cell carcinoma. We look forward to advancing this late-stage asset as part of our broad oncology R&D program.”
STING agonist-expressing dual innate immune activator SYNB1891 + Atezolizumab to be tested in patients with advanced solid tumors
“This collaboration is an important step in advancing SYNB1891 as a potential treatment for difficult to treat cancers as it provides us with access to an important checkpoint inhibitor, atezolizumab, while allowing us to maintain ownership of our novel development candidate,” said Aoife Brennan, M.B. Ch.B., Synlogic’s president and chief executive officer. “We believe that SYNB1891 has potential to offer a new and meaningful approach in the fight against cancer when used in combination with checkpoint inhibitors, by potentially enhancing their potency and effectiveness.”
BioPharma and MedTech
FDA approves first and only gene therapy Zolgensama for Spinal Muscular Atrophy (SMA)
The FDA approved the first and only gene therapy Zolgensama for SMA developed by AveXis, a Novartis company. The current treatment applies to patients under 2 years of age with bi-allelic mutations in survival motor neurons 1 (SMN1) gene. Priced at $2.125M for one-time infusion, the cost of the therapy is 50% less than Biogen’s Spinraza that includes severe side effects including paralysis, breathing difficulties and early death. Novartis is also ramping up the manufacturing facility to meet the future demand for gene therapy.
German Biotech-CRO hybrid Evotec acquires Just Biotherapeutics for $90M
Evotec diversifies its portfolio and enters biologics market by acquisition of Seattle-based Just Bio for $90M including its key talents and ML driven technology platform, J.DESIGN. The buyout boosts Evotec’s offering in areas including oncology, CNS disorders, pain, inflammation, infectious diseases and metabolics.
 
Click Here for more on  deals – M&A – Fund raising – Investments and more..
Editors' Desk
Content Editors 
Concept and Design Team
Share
Tweet
Forward
Subscribe
Disclaimer
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.
Copyright © 2019 MedNess , All rights reserved.
You are receiving this MedNess Newsletter as a subscriber on the list.

Cover Image : Pixabay
Images : Twitter
Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
Our mailing address is:
MedNess
2160 Matthews Avenue 
Bronx 10462, NY 
NY

Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.