Onco-This-Week (OTW) is here with the oncology clinical development weekly updates.
📁Subscribe to get your OTW newsletter directly weekly to your inbox at: https://lnkd.in/e3WDGyVz
🔬REGULATORY NEWS
📌FDA grants BTD Roche inavolisib for HR+ve, HER2-ve BC with PIK3CA mutation
📌FDA Updates Action Date for Bristol Myers Squibb Subcutaneous Nivolumab, new PDUFA: December 29, 2024
📌Verastem Oncology Rolling Submission of NDA to FDA initiated for Avutometinib + Defactinib for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer
📌FDA Granted FTD Theriva Biologics, Inc. VCN-01 for Metastatic Pancreatic Cancer
📌RMAT & PRIME Designations granted Wugen WU-CART-007
📌FDA grants ODD Cantex Azeliragon for Pancreatic Cancer
📌NMPA: Granted Priority Review Designation to the NDA for Jacobio Pharma Glecirasib
📢TRIAL RESULTS
📌AstraZeneca Datopotamab deruxtecan showed clinically meaningful OS improvement vs. chemo in NSCLC TROPION-Lung01 Ph III
📌Verastem Oncology +ve Initial Interim Safety and Efficacy Results Announced RAMP 205 Trial Avutometinib, Defactinib, Gemcitabine and Nab-paclitaxel combo in 1L Pancreatic Cancer
📊TRIAL STATUSES
📌Tango Therapeutics Development of TNG348 program to be discontinued
📌First Patient Dosed: Tyligand Bioscience Ph 1/2 CT TSN1611; Indaptus Therapeutics, Inc. Decoy20 trial & GigaGen Inc Ph1 Trial GIGA-564 in Advanced Solid Tumors; Adlai Nortye Randomized Ph II CT Palupiprant for Rectal Cancer; Edgewood Oncology Ph2a BTX-A51 in BC
💼BUSINESS NEWS
📌Dragonfly Therapeutics, Inc. Announces Clinical Collaboration to Evaluate DF9001 + KEYTRUDA in Solid Tumors
📌Nanobiotix and Janssen Inc. aligned at the collaboration’s Joint Strategy Committee to transfer the global sponsorship of the Ph 3 pivotal head and neck cancer trial
📌Genmab Completes Acquisition of ProfoundBio
📌Nona Biosciences Announces Global License and Option Agreement with AstraZeneca for mAb development for Novel Tumor Targeted Therapies
📌Collaborations: OSE Immunotherapeutics & Boehringer Ingelheim to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases ; Achilles Therapeutics plc & Arcturus Therapeutics for Personalized mRNA Cancer Vaccines
📌Indapta Therapeutics Awarded $4.5 M by CPRIT to Advance Clinical Development of its Allogenic NK Cell Therapy
📌ReEngage Therapeutics Launches to Develop ACSS2 Inhibitor Compounds for Cancer Indications
✍️ OTW TEAM
Richa Tewari, PhD, Author
Shalini Roy Choudhury, PhD and Anusha Jayaraman, PhD, Managing Editors
Himanshi Agarwal, PhD and Siftjit Kaur, PhD, Social Media Managers
Global Pharma Lead | Board Member | Advisor | Non-Profit | Servant Leader
2moNice summary, Matthew Cunningham I couldn’t agree more: it is time to help patients get to the right, targeted therapy.