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MedNess: bite-size biopharma and medtech news

9th March, 2022
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MedNess This Week
HIGHLIGHTS
 
Drug Approvals
U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with R/R Multiple Myeloma
“We are committed to harnessing our science, deep disease understanding and capabilities to bring forward cell therapies like CARVYKTI as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “We extend our sincere gratitude to the patients, their families and the teams of researchers and study centers who have participated in the clinical study of CARVYKTI and enabled today’s approval.”
Regulatory News
Current Topline Data from the SIENDO Study Unlikely to Support sNDA Approval; New Study of Selinexor in the Advanced or Recurrent p53 WT Endometrial Cancer to be initiated to Support a Future sNDA Submission
"We strongly believe in selinexor's potential in patients with p53 wild-type and are excited to further evaluate it in this patient population to better understand its potential to address the unmet need in women with endometrial cancer," said Sharon Shacham, Chief Scientific Officer of Karyopharm. "Given the significant need for new therapeutic options, we have a tremendous sense of urgency to design and enroll a new trial as quickly as possible and believe we are well-positioned to do so working with our existing SIENDO clinical trial sites."
U.S. FDA BLA/sNDA PDUFA Date for Ublituximab Plus UKONIQ® (U2) to Treat Patients with CLL and SLL extended
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “As mentioned on our earnings call earlier this week, we believed an extension of the PDUFA date was a likely scenario especially given the proposed timing of the upcoming ODAC meeting. We hope this extension provides the time needed to give proper attention and review to the U2 BLA/sNDA.” Mr. Weiss continued, “We continue to believe in the potential of U2 to provide a meaningful treatment option to patients with CLL and SLL.”
Click here for more Regulatory News
Trial Results
Positive Results from Ph 3 Esophageal Cancer Study of Toripalimab Published in Cancer Cell
“The robust results from the JUPITER-06 study add to the emerging body of clinical evidence of toripalimab’s clinical activity across multiple tumor types. Importantly, ESCC patients with low PD-L1 expression represent a high unmet need, and we are encouraged by these results in patients with ESCC and the potential of toripalimab plus chemotherapy to offer improved clinical outcomes for these patients,” said Denny Lanfear, CEO of Coherus. “We are working closely with our partners at Junshi Biosciences to make toripalimab and additional complementary immuno-oncology agents available to patients in the U.S. as part of our mission to advance patient care and outcomes in oncology.”
NuTide:121 study of Acelarin plus cisplatin to be discontinued following IDMC recommendation due to lack of clinical benefit
“This disappointing news highlights the challenges associated with developing new medicines for patients with biliary tract cancer,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “NuCana will carefully review these data to determine future potential development pathways for Acelarin. We are extremely grateful to all the patients, their families, the investigators and other health care professionals involved in the NuTide:121 study.”
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Trial/Program Status
First Patient Dosed in ASPEN-06, a Ph 2/3 Study of Evorpacept for the Treatment of Patients with Advanced Gastric or Gastroesophageal Junction Cancer
“Patients with HER2-positive gastric/GEJ cancer are in need of tolerable and effective treatments, particularly in the 2nd line and later settings where resistance to HER2-directed therapy may have developed,” said Keun-Wook Lee, M.D., Ph.D., Professor of Seoul National University College of Medicine and Director of Clinical Trials Center, Seoul National University Bundang Hospital, Seoul, Korea. “Evorpacept’s favorable tolerability coupled with its novel approach of enhancing antibody dependent cellular phagocytosis engages the individual’s own innate anti-cancer immune response distinguishing it from other HER2-targeted approaches.”
First Patient Dosed in Ph 1/2 Acclaim-1 Clinical Trial of REQORSA™ Immunogene Therapy in Combination with Tagrisso® to Treat Non-Small Cell Lung Cancer
“This is an exciting milestone for Genprex that we believe brings us one step closer to achieving our goal to validate the potential benefits of REQORSA in NSCLC patients who have life-limiting disease and few treatment options,” stated Mark S. Berger, M.D., Chief Medical Officer of Genprex. “Based on both the preclinical data and previous clinical data, REQORSA has the potential to improve the response to current targeted therapies, such as Tagrisso, for this study patient population. We look forward to continuing to advance this important trial.”
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MedNess Business
Onco-News
Adagene Announces SAFEbody® Multi-Target Collaboration with Sanofi for Novel Masked Immuno-Oncology Antibody Candidates
“Committed to chasing the miracles of science, we look forward to working with Adagene to design antibodies that can help us deliver on our mission to bring transformative new medicines to people living with cancer,” said Valeria Fantin, Global Head of Oncology Research, Sanofi. “Adagene’s antibody platform should help us to precisely target established, but poorly addressed oncology mechanisms with best-in-class medicines.”
Blueprint Medicines and Proteovant Therapeutics Announce Strategic Collaboration to Advance Novel Targeted Protein Degrader Therapies
"At Blueprint Medicines, we strive to stay on the cutting edge by identifying emerging precision medicine technologies with potential to complement and further amplify our highly productive research platform," said Fouad Namouni, M.D., President of Research and Development at Blueprint Medicines. "Recent scientific advancements in the field of targeted protein degradation have revealed opportunities to expand our core kinase capabilities and explore new ways to treat difficult to drug and novel targets, as well as address on-target resistance mechanisms. This collaboration with Proteovant Therapeutics will enable us to expand our platform more quickly in our mission to improve outcomes for patients with cancer and blood disorders."
Click here for more on 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
Manoj Mishra
Neuroimmunology and immunotherapies
Darpan Chakraborty
Social Media Manager
IP & BioPharma News
 
Nisha Peter, PhD
Consulting Editor

 
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
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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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