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MedNess: bite-size biopharma and medtech news

Onco-this-Week
3rd September, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals
European Commission approves Atezolizumab + nab-paclitaxel in PD-L1+ve mTNBC patients based on Ph III IMpassion130 trial data
“For the past 30 years, we have been dedicated to transforming the lives of people with breast cancer. Now, we are pleased to build on this foundation with the news that the first immunotherapy treatment for triple-negative breast cancer is available to people in Europe with PD-L1-positive, metastatic triple-negative breast cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The European approval of this Tecentriq combination represents a significant step forward in the treatment of this aggressive breast cancer, where the unmet medical need is great.”
European Commission approves Elotuzumab + Pomalidomide and low-dose Dexamethasone (EPd) for RRMM patients based on Ph II ELOQUENT-3 trial results
“Multiple myeloma is a frequently recurring disease and the chance it will return after initial treatment is a heavy burden for patients to carry,” said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. “We are proud that the European Commission has again recognized the role of Empliciti in helping European patients with multiple myeloma by approving a second Empliciti-based regimen in the relapsed and refractory setting.”
Onco-Trial Results
Positive Ph II MERECA trial results of ilixadencel + Sunitinib announced in mRCC patients
“As a clinical oncologist specialized in treating kidney cancer patients, the prospect of an immune primer that can support the achievement of complete responses in advanced-stage patients with a positive tolerability and safety profile is extremely exciting, especially in an indication in which complete responses are rare,” commented Dr. Magnus Lindskog, Associate Professor at Uppsala University Hospital and MERECA investigator. “If this response rate can be confirmed in a larger pivotal trial, it would represent a major step forward for the treatment of kidney cancer patients.”
Encouraging interim data announced from Ph Ib trial of oral HDAC inhibitor Abexinostat + Pembrolizumab in multiple solid tumors patients
“Abexinostat is known mechanistically to have potential synergy with immune checkpoint inhibitors. We are very pleased with the interim data reported today by UCSF, a world leader in solid tumor clinical research. The data reported today indicate the combination of abexinostat with Keytruda® could be safe and well tolerated and there is preliminary evidence demonstrating efficacy and the potential to reverse resistance to immune checkpoint blockade. We expect to report additional data at a scientific conference early next year.” Mr. Y. Mark Xu, Chairman and CEO of Xynomic commented.
Rova-T tanks in Ph III MERU trial in 1L maintenance ED SCLC; AbbVie to terminate Rova-T research program
  • MERU trial terminated post interim analysis, which failed to show any survival benefit
  • Rova-T had already failed in 2L (TAHOE) and 3L TRINITY trial
  • With Atezolizumab in 1L SCLC and Pembrolizumab in previously treated patients, Rova-T had already lost the war from a commercial standpoint
Onco-Trial Status/Progress
Patient dosing initiated in Ph I trial of ARV-471 in locally advanced or metastatic ER+, HER2neg breast cancer patients
“ARV-471 is a potent ER degrader that has demonstrated significant anti-tumor activity in preclinical models, and we are hopeful it will address an important need for patients with advanced ER positive breast cancer not adequately treated with current standards of care,” said Ronald Peck, M.D., Chief Medical Officer of Arvinas. “ARV-471 is Arvinas’ second targeted protein degrader to enter the clinic, making this another exciting and significant development for our company and the field.”
Diagnostic Assays
VENTANA PD-L1 (SP142) Assay launched in CE markets as first companion diagnostic to identify TNBC patients eligible for treatment with Atezolizumab
“Until recently, the only treatment option for metastatic triple-negative breast cancer patients was chemotherapy,” said Thomas Schinecker, Head of Roche Diagnostics. “With our expanding menu of companion diagnostics and targeted cancer immunotherapies, Roche is proud to continue to deliver on our mission to make personalised healthcare a global reality, ensuring the right treatment for the right patient at the right time.”
MedNess Business
Onco-News
Celgene to co-develop three cell therapies against cancer with Immatics
Celgene and Immatics Biotechnologies GmbH entered into a strategic collaboration to develop adoptive cell therapies targeting multiple solid tumors. Under the agreement, Celgene will pay $75 million upfront for the three programs and may pay upto $505 million for each licensed product in option exercise payment, development, regulatory and commercial milestones as well as tiered royalties. Immatics will develop and validate the programs through the lead candidate stage after which Celgene may opt-in to develop, manufacture and commercialize the T-Cell Receptor Engineered T-cell Therapy (TCR-T). 
Jobs at Immatics Germany
Jobs at Immatics USA
Jobs at Celgene
Adaptimmune and Noile-Immune to co-develop SPEAR T-cell products as a next-gen treatment for cancer patients
Adaptimmune Therapeutics and Noile-Immune Biotech enter into partnership for preclinical development of cell therapies against cancer. Both the companies will collaborate to co-develop next-generation SPEAR T-cell products combining Noile-Immune’s PRIME (PRoliferation Inducing and Migration Enhancing) technology expressing both IL-7 and CCL19. Under the agreement, Adaptimmune will provide an upfront cash payment and milestone-based payments of up to $312 million to Noile-Immune for all programs. 
Jobs at Adaptimmune
BioPharma and MedTech

Philips and LindaCare announce partnership to advance cardiac care
The global health technology company Royal Phillips has announced partnership with LindaCare, a digital health company, for advanced cardiac care of the patients. The OnePulseTMcloud-based solution developed by LindaCare will be combined with Philips’ IntelliSpace Cardiovascular informatics platform to remotely monitor the patients with cardiac implantable electronic devices (CIEDs). This allows the clinicians to monitor patients remotely and also streamline reporting for patients with CIEDs during hospital visits. Philips has owned a majority stake in LindaCare through its Philips Health Technology Ventures.
Jobs at Philips
Jobs at LindaCare
Viela Bio files an IPO to raise $150 million
Viela Bio, an AstraZeneca spin-off, focusing on severe inflammation and autoimmune diseases has filed an IPO to raise $150 million. The funds will be used for commercialization of inebilizumab, an anti-CD19 antibody targeting neuromyelitis optica spectrum disorder (NMOSD) that has been accepted by FDA for review on August 27, 2019. Additionally, the funds will also focus on development of other assets including VIB4921, a fusion protein that binds to CD40 ligand targeting Sjögren’s syndrome and kidney transplant rejection currently in phase II, and VIB7734 currently in phase 1b against multiple autoimmune diseases. As a part of the agreement, AstraZeneca provides Viela with manufacturing, clinical and commercial services.
Jobs at Viela
HiFiBio raises $67 million in series C for advancing oncology and autoimmune pipeline
HiFiBio Therapeutics has raised $67 million in series C financing round for expansion of its platform focused towards oncology and autoimmune diseases. The company combines its biological expertise with comprehensive single cell profiling technologies to target the patient subsets more precisely. The new funding partners including IDG Capital, Delian Capital, Hanne Capital and Kite Pharma, a Gilead company, join in along with the existing investors Sequoia Capital China, VI Ventures, Legend Star Capital and LYFE Capital.
Jobs at HiFiBio
Click Here for more collaborations, acquisitions, mergers and licensing...
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 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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