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MedNess: bite-size biopharma and medtech news

18th May, 2022
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MedNess This Week
HIGHLIGHTS
 
Drug Approvals
Enhertu approved in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen
Erika Hamilton, MD, Director of the Breast Cancer and Gynecological Cancer Research Program for Sarah Cannon Research Institute, Nashville, Tennessee, US, said: “Enhertu has demonstrated significant progression-free survival in the earlier metastatic setting, potentially establishing it as a new standard of care in previously treated patients with HER2-positive metastatic breast cancer. Today’s approval is an important milestone for the clinical community as we will now be able to offer Enhertu to these patients earlier in their treatment.”
Regulatory News
Breakthrough Therapy Designation Granted for Repotrectinib Treatment in Patients With One Prior ROS1 Tyrosine Kinase Inhibitor and no Prior Chemotherapy
“We are excited to receive our third BTD and eighth overall FDA regulatory designation for repotrectinib in an indication where there are no approved targeted therapies,” said Mohammad Hirmand, M.D., Chief Medical Officer. “We are encouraged by the continued momentum in TRIDENT-1 with enrollment targets achieved in cohorts EXP-1, EXP-4 and EXP-6. We look forward to continuing to progress repotrectinib toward registration with our first pre-NDA meeting with the FDA to discuss the topline data by blinded independent central review from the ROS1-positive advanced NSCLC cohorts of the TRIDENT-1 study expected later this quarter.”
Imfinzi plus chemotherapy granted Priority Review in the US for patients with locally advanced or metastatic biliary tract cancer based on TOPAZ-1 Ph 3 trial
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “People with advanced biliary tract cancer have faced poor outcomes and limited treatment options for too long, and today’s news for the TOPAZ-1 trial underscores the urgency to deliver new, effective therapies in this setting. We are working closely with the FDA to bring the first immunotherapy-based option to patients with this devastating cancer and potentially set a new standard of care with Imfinzi plus chemotherapy.”
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Trial Results
FAILED TRIAL: Ph 3 SKYSCRAPER-01 study evaluating tiragolumab plus Tecentriq did not meet its co-primary endpoint of PFS
“While these results are not what we hoped for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We continue to believe that TIGIT may have a role in cancer treatment and we will share additional results from our tiragolumab programme as they emerge.”
Positive Interim Results announced From Ph 2 Trial With VB10.16 + Atezolizumab In Advanced Cervical Cancer
“We are thrilled to report these positive interim safety and efficacy results from our Phase 2 trial with VB10.16, which showed evidence of durable anti-tumor activity in a heavily pre-treated population of patients with late-stage cervical cancer,” said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. “These interim results support Nykode’s unique approach of targeting Antigen-Presenting Cells (APCs), designed to produce a robust and long-lasting CD8 killer T cell response against cancer cells. We look forward to reporting updated efficacy data readouts from the Phase 2 trial during the first half of 2023 as we continue to advance our cervical cancer program.”
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Trial/Program Status
Ph 2b TNBC clinical trial combining ZEN-3694 + Talzenna (talazoparib) to be initiated
“The data from the Phase 1b/2 trial has shown that the ZEN-3694 plus talazoparib combination regimen induced durable responses in tumors of TNBC patients which do not harbor mutations in BRCA1/2," said Dr. Mark Robson, a principal investigator and medical oncologist at The Memorial Sloan Kettering Cancer Center. “These clinical results confirm the rationale and data from pre-clinical experiments which have shown that BET inhibition can sensitize wild type BRCA1/2 TNBC tumors to PARP inhibition. This interesting data warrants the continued clinical evaluation of this combination”
First Patient Dosed in Multi-Regional Global Ph 2 Clinical Trial of ALK-1 Antibody and Nivolumab Combination Therapy for the Treatment of Advanced HCC
Dr. Tong Youzhi, founder, Chairman, and CEO of Kintor Pharma, commented, “We are delighted to complete the first patient dosing in the phase II multi-regional clinical trial of GT90001 combined with Nivolumab for the treatment of advanced HCC. We expect this phase II MRCT study would position GT90001 well as a combination candidate with I/O for the second-line treatment of HCC. We are also selecting clinical strategies for GT90001 in other solid tumors and hope to bring more innovative treatment options for patients with unmet needs.”
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MedNess Business
Onco-News
BridgeBio announces exclusive license agreement with BMS to develop and commercialize BBP-398 in oncology
“We are grateful to be expanding our collaboration with Bristol Myers Squibb, a leader in oncology, and we believe this agreement will allow us to reach even more patients with difficult-to-treat cancers. We believe our SHP2 inhibitor has the potential to be a best-in-class agent given the data we have seen, and we are eager to see our monotherapy and combination trials progress in collaboration with our partners at Bristol Myers Squibb,” said Neil Kumar, Ph.D., founder and CEO of BridgeBio.
Gilead and Dragonfly Announce Strategic Research Collaboration to Develop Natural Killer Cell Engagers in Oncology and Inflammation
“We are excited to partner with Dragonfly as we expand our pipeline with innovative NK cell engager programs. Using our scientific framework to focus our efforts, we are growing our portfolio with assets that have complementary MOAs and strong scientific rationale for combination opportunities,” said Flavius Martin, MD, Executive Vice President, Research at Gilead. “We look forward to working with the Dragonfly team to explore novel NK engager treatments across diverse therapeutic areas to address some of the greatest gaps in care for cancer and inflammatory diseases.”
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
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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.
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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
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