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MedNess: bite-size biopharma and medtech news

2nd March, 2022
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MedNess This Week
HIGHLIGHTS
 
  Drug Approvals
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Approved in Japan for Radically Unresectable or Metastatic Renal Cell Carcinoma
“Today’s milestone for KEYTRUDA plus LENVIMA as a treatment for radically unresectable or metastatic renal cell carcinoma is particularly exciting as it marks the second approval for the combination in Japan,” said Terushige Iike, President of Eisai Japan, Senior Vice President, Eisai. “We are thrilled to be able to provide Japanese patients with a new treatment option, illustrating our shared commitment with Merck to develop therapies with the aim of addressing the unmet needs of those living with difficult-to-treat cancers. We would like to thank the patients, families and healthcare providers who made this approval possible.”
U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for KEYTRUDA® to Identify Patients with MSI-H Solid Tumors
“Immunotherapy has huge promise as a potential treatment option for patients with advanced cancer; however, identifying those who may benefit is complex and requires high-quality diagnostics,” said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. “Not only could this approval allow more patients to benefit from KEYTRUDA, but it also underscores an important shift toward tumor-agnostic cancer care.”
  
  Regulatory News

Positive CHMP Opinion granted to ORGOVYX® (relugolix) for the Treatment of Advanced Prostate Cancer
“This positive CHMP opinion represents another step toward positioning ORGOVYX® as a new standard of care for men with advanced prostate cancer,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “We look forward to providing patients and physicians in Europe with the first oral, androgen deprivation therapy treatment to further advance our mission to redefine care for men with prostate cancer.”

U.S. FDA accepts sNDA for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia
“We are pleased with the FDA’s acceptance of BRUKINSA’s filing in CLL. This is an important milestone in BRUKINSA’s global registration program. With superiority in investigator-assessed ORR over ibrutinib in ALPINE for relapsed or refractory patients and in PFS over chemoimmunotherapy in the SEQUOIA study for treatment-naïve patients, BRUKINSA has demonstrated its potential to improve treatment outcomes for CLL patients,” commented Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene. “We look forward to furthering our discussions with the FDA on this filing and the potential to bring this important treatment option to the CLL community in the U.S.”
Click here for more Regulatory News
Trial Results
Preliminary Safety Data Announced on PDS0101 in Combination With KEYTRUDA® (pembrolizumab)
“We are encouraged by the preliminary safety data of PDS0101 in combination with KEYTRUDA® for patients with recurrent or metastatic HPV16-positive head and neck cancer,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “These data and the preliminary efficacy data continue to support the unique combination of safety and potency of our novel Versamune® platform.”
Enhertu Significantly Improved Both Progression-Free and Overall Survival in DESTINY-Breast04 Trial in Patients with HER2-Low Metastatic Breast Cancer
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca said: “Today’s historic news from DESTINY-Breast04 could reshape how breast cancer is classified and treated. A HER2-directed therapy has never-before shown a benefit in patients with HER2-low metastatic breast cancer. These results for Enhertu are a huge step forward and could potentially expand our ability to target the full spectrum of HER2 expression, validating the need to change the way we categorise and treat breast cancer.”
Click here for more Trial Results
Trial/Program Status
First Cancer Patient dosed with a Combination of ZEN-3694 + OPDIVO in Ph 1/1b clinical study in patients with solid tumors and ovarian cancer
“I am very excited to move this combination concept into the clinic through the National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP),” said Dr. Haider Mahdi, a principal investigator and medical oncologist at University of Pittsburgh Medical Center. “We have shown preclinically that BET inhibitors enhance the activity of checkpoint inhibitors by improving the tumor immune microenvironment. We expect the combination to be particularly effective in patients with MYC and BRD4 amplified ovarian cancer which has very poor outcomes and is difficult to treat.”
First Pancreatic Cancer Patient Enrolled at Columbia University’s New York-Presbyterian Hospital Irving Medical Center in Ongoing TIGeR-PaC Ph 3 Clinical Trial
Dr. Bates added, “Treatment options have been limited to systemic chemotherapy for most patients. Local perfusion allows us to deliver much higher concentrations of an effective agent to the tumor. In the TIGeR-PaC trial, the tumor is temporarily isolated and saturated with gemcitabine, a well validated chemotherapeutic agent.  In comparison to systemic chemotherapy treatment, RenovoRx has shown in its Phase 1/2 clinical trials that its therapy platform delivers a higher concentration of chemotherapy directly to the tumor with reduced patient side effects. This trial will offer a proof-of-principle that could establish direct delivery of chemotherapy as a strategy for treating pancreatic cancer in various settings.”
Collated by: Richa Tewari, PhD 
Genes and Therapy
Positive interim clinical data for cell therapy for Degenerative Disc Disease
DiscGenics Inc. announced positive interim data from its ongoing Phase 1/2 clinical trial of IDCT (rebonuputemcel), an allogeneic injectable discogenic cell therapy for degenerative disc disease (DDD). The primary efficacy endpoint of the study was achieved, with statistically significant improvement in back pain observed in the high dose IDCT group. The company is in the process of analyzing data from patient follow-up visits at weeks 78 and 104. The company intends to submit the full dataset to the U.S. Food & Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) for consideration in an End of Phase 2 meeting targeted for the second half of 2022. 
New Generation of AAV Vectors to be developed for Type 1 and Type 2 Diabetes Gene Therapy
Perkin Elmer’s Sirion Biotech and Centre for Genomic Regulation (CRG) have entered into an agreement to jointly develop new generation adeno-associated virus (AAV) vectors for type 1 and type 2 diabetes gene therapy in the pancreas. The collaboration combines SIRION’s AAV technology platform and expertise in viral vector development and production with CRG’s deep knowledge of genetic regulatory mechanisms. his new approach aims to increase the precision, safety, and efficacy of future AAV-based gene therapies for diabetes..
MedNess Business
Onco News
BioNTech and Medigene Announce Global Collaboration to Advance T Cell Receptor Immunotherapies Against Cancer
“This collaboration with Medigene expands our cell therapy portfolio and TCR discovery capabilities, and further strengthens our ability to be a leader in the rapidly emerging field of engineered cell therapies,” said Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “We look forward to working closely with Medigene to develop new treatments which address solid tumors with high unmet medical need.”
Actinium Pharmaceuticals and AVEO Oncology Enter Research Collaboration Agreement to Develop First-in-Class Actinium-225 ErbB3 Targeting Radiotherapy for Solid Tumors
"Actinium has amassed extensive clinical experience, technical know-how and research capabilities for the development of next-generation targeted radiotherapies that we are excited to bring to this collaboration with AVEO, which has a portfolio of high-affinity antibodies and is currently commercializing FOTIVDA (tivozanib) in advanced RCC. We believe ErbB3 is a validated and differentiated target that is aptly suited for radio-conjugate development. Using our AWE platform, we will harness the powerful Ac-225 payload to enhance targeted cell killing against a target that is overexpressed in a number of cancers that are difficult to treat with traditional oncology therapies. A member of the epidermal growth factor family of receptors, ErbB3 has been gaining increasing recognition as a validated targeted, we are committed to rapidly advance and evaluate this novel Ac-225 ErbB3 targeted radiotherapy together with AVEO," said Sandesh Seth, Chairman and CEO of Actinium.
Collated by: Richa Tewari, PhD 
Career Event
Industry Careers for PhDs – Panel Discussion and Networking Events on March 9 and 15 for R&D and Non-Bench Jobs
 
Register here for Wednesday, March 9, 5:00-6:30pm EST – Zoom event on Drug Discovery Research Careers
Register here for Tuesday, March 15, 5:00-6:30pm EST – Zoom event on Drug Discovery Non-Bench Careers
 
Register for one or both sessions!
All Eventbrite registrants will receive the Zoom meeting link via email on the day of the event. 

Are you a PhD student or postdoc interested in learning more about industry career options, both bench and non-bench?
 
Attend 2 Zoom panel discussion and networking events hosted by the MSKCC Office of Career and Professional Development, STEMPeers, and INet NYC, as part of our 3rd annual event on launching an industry career!
 
On March 9, 5:00-6:30pm EST, you will meet with 7 scientists working in various types of therapeutic development (small molecule, cell, gene), as well as medicinal chemistry, AI and data science, and CMC.
 
On March 15, 5:00-6:30pm EST, you will meet with 6 industry professionals who have transitioned into various non-bench roles, including clinical research, business development, medical science liaison and medical affairs, medical communications, and regulatory/QC.
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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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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Cover Image : iStock
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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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