On September 10, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that it has received positive feedback from its Pre-IND meeting with the U.S. Food and Drug Administration (FDA), which is a step forward to opening an IND to conduct a Phase 1/2 study of its personalized off-the-shelf immunotherapy, Bria-PROS+, in advanced prostate cancer (Press release, BriaCell Therapeutics, SEP 10, 2024, View Source [SID1234646467]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We were truly impressed by the FDA team of experts’ keen interest in Bria-PROS+ as a potential novel personalized approach for advanced prostate cancer," stated Dr. William V. Williams, BriaCell’s President and CEO. "Despite numerous approved drugs, prostate cancer remains the second-leading cause of cancer death in American men. We view the FDA’s positive feedback as a major step forward in the clinical development of our Bria-PROS+ and in our efforts to bring hope to patients and families suffering from this deadly disease."
As a result of the Pre-IND meeting, FDA waived the animal toxicology and animal pharmacokinetic (PK) studies requirement for opening the IND, greatly simplifying the development pathway for Bria-PROS+. Other areas of discussion included BriaCell’s plan to initiate the Phase 1/2 study pending completion of standard manufacturing and testing requirements. These interactions also inform the further development of the proprietary Bria-OTS+ platform as the company pursues the development of Bria-BRES+, Bria-LUNG+ and Bria-MEL+, for breast cancer, lung cancer and melanoma, respectively.
BriaCell is currently evaluating its personalized immunotherapy Bria-BRES in a phase 1/2a study in metastatic breast cancer (ClinicalTrials.gov NCT06471673).