View this email in your browser

MedNess: bite-size biopharma and medtech news

25th May, 2022
Subscribe here
Onco-this-Week
HIGHLIGHTS
 
Regulatory News
MAA submitted to the European Medicines Agency for Investigational Adagrasib as a Treatment for Previously-Treated KRASG12C-mutated NSCLC
"The submission of our application to the EMA is a significant milestone for Mirati and brings us closer to expanding the potential availability of adagrasib to patients with KRASG12C-mutated lung cancer in the European Union, if approved," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "Therapeutic options for KRASG12C-mutated lung cancer are limited, and this submission is an important step forward in our goal to deliver innovative, differentiated therapies in areas of high unmet need. We look forward to working with the EMA to potentially bring this therapy to patients.  We also thank the patients and investigators who make our work possible by participating in clinical trials."
BLA accepted for Mirvetuximab Soravtansine in Ovarian Cancer by the FDA with Priority Review
“FDA’s acceptance of our BLA under Priority Review reinforces our belief in the potential for mirvetuximab soravtansine to serve as a new standard of care for patients with FRα-high platinum-resistant ovarian cancer,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “We are pleased to be one step closer to realizing the promise of our technology and are working closely with FDA to support the evaluation of our application. We are moving quickly to build out the commercial and medical infrastructure required for a successful launch and look forward to the prospect of delivering mirvetuximab soravtansine to patients later this year.”
Click here for more Regulatory News
Trial Results
Sarclisa® (Isatuximab) Combination Provides Unprecedented mPFS In Patients With Relapsed Multiple Myeloma Receiving A Proteasome Inhibitor Therapy
Philippe Moreau, MD, Head of the Department of Hematology, University Hospital of Nantes, France said, “The increase in progression free survival, observed consistently across all subgroups, when adding Sarclisa to carfilzomib and dexamethasone is remarkable in patients with relapsed multiple myeloma in a proteasome inhibitor combination. Relapse is common in multiple myeloma, creating the need for differentiated second-line treatments that provide patients a longer period of time without disease progression. This updated analysis reinforces the potential for Sarclisa to become a new standard of care for patients with relapsed multiple myeloma.”
FAILED TRIAL: Ph 3 CheckMate-901 trial of Opdivo + Yervoy vs SoC in 1L patients with unresectable or metastatic urothelial carcinoma did not meet the primary endpoint of OS in PD-L1+ve patients
“Despite some progress in recent years, metastatic urothelial carcinoma remains a difficult disease to address, with a limited number of treatment options that can extend patients’ lives,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Opdivo plus Yervoy has demonstrated durable, long-term survival improvements in several challenging-to-treat advanced cancers, and we are disappointed that the final analysis of CheckMate -901 did not show this same benefit in urothelial carcinoma patients whose tumor cells express PD-L1 ≥1%. We remain committed to advancing research in urothelial carcinoma, we look forward to seeing data from other parts of the CheckMate -901 trial, and we thank all of the patients, investigators and site personnel involved.”
Click here for more Trial Results
Trial/Program Status
Ph 3 Combination Trial of IO102-IO103 and KEYTRUDA® as First-Line Treatment in Advanced Melanoma initiated
“We are pleased to treat the first melanoma patient, kicking off in Florida and expanding this Phase 3 study with a therapy that has received an FDA Breakthrough Designation across multiple centers in the US, Europe and Australia. This is a strong manifestation of our broad, late-stage development program,” said Mai-Britt Zocca, Ph.D., President and CEO IO Biotech. “Executing this clinical trial builds on IO Biotech’s recent momentum including financial, international, and organizational expansion.”
DSTAT Development Program Terminated to focus Resources on Imipridone Platform; Ph 3 Randomized Study of ONC201 in H3 K27M Mutant Glioma Expected in 2022
“We continue our engagement with the U.S. Food and Drug Administration (FDA) regarding the development of ONC201. While we have not yet requested formal feedback on a potential NDA submission for accelerated approval, communication from the FDA makes it clear that the potential for accelerated approval is more challenging than previously anticipated. This is consistent with the evolving policy the agency has expressed towards single arm studies, generally. As such, we are prioritizing the initiation of a randomized Phase 3 study by year-end. Given the strength of the data already presented and the extent of the unmet patient need, we still believe an accelerated approval is possible and plan to complete the work already underway to support a potential NDA submission,” added Mr. Sherman.        
Click here for more Trial Statuses
MedNess Business
Onco-News
Proteros Expands Oncology Collaboration And License Agreement With AstraZeneca
“The expansion of our agreement with AstraZeneca with an additional drug discovery program reflects our successful ongoing collaboration to identify selective inhibitors for notoriously challenging disease targets,” said Dr. Torsten Neuefeind, CEO of Proteros. “This agreement strengthens our collaboration with a global biopharmaceutical leader and we look forward to joining forces again to discover novel inhibitors with the potential to effectively treat cancer patients in the future.”
Bayer ends exclusive worldwide licensing agreement for next-generation mesothelin-directed CAR T-cell therapies with Atara Biotherapeutics
“We acknowledge Bayer’s decision to end our collaboration following Bayer’s strategic review and asset-level prioritization of its pipeline, including cell and gene therapy,” said Jakob Dupont, M.D., Head of Global Research & Development at Atara. “Based on the clinical and pre-clinical data generated to date, we remain confident in the potential of ATA2271 and ATA3271 to address patient need in solid tumors and are re-assessing our strategy on how best to generate value from the programs moving forward.”
Click here for more mergers, acquisitions and business news
Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Debarati Banik
HealthIT
Sohini Dutta
BioPharma News
MedNess Plus
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
Nisha Peter, PhD
Consulting Editor
Share Share
Tweet Tweet
Forward Forward
Subscribe
Disclaimer
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.
Copyright © 2019 MedNess , All rights reserved.
You are receiving this MedNess Newsletter as a subscriber on the list.

Cover Image : iStock
Images : Twitter , Unsplash.com
Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
Our mailing address is:
MedNess
1150 First Ave. King of Prussia,, PA 19406

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