BriaCell Therapeutics Corporation is delighted to announce that its lead clinical candidate, Bria-IMT™, in combination with a checkpoint inhibitor, has been met with agreement and praise from the U.S. Food and Drug Administration following its End of Phase II meeting for advanced metastatic breast cancer.
The FDA has given BriaCell’s Fast Track Phase I/IIa data the green light, approving the primary end point, the vital components of the pivotal registration study design, and the types of patients to be included. This is a major step forward in the development of this innovative and potentially game-changing therapy.
The successful completion of BriaCell’s clinical trial could pave the way for their novel immunotherapy to receive approval for commercialization through a Biologics License Application (BLA) submission. This could revolutionize the world of immunotherapy, offering patients a more effective and personalized treatment.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is thrilled to announce that it has received a positive outcome from its End of Phase II meeting with the FDA. The meeting was concerning BriaCell’s lead clinical candidate, Bria-IMT™, in combination with a checkpoint inhibitor, which has been granted Fast Track designation for advanced metastatic breast cancer.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT), a pioneering biotechnology company specializing in targeted immunotherapies for cancer, is delighted to announce that it has achieved a positive outcome from its End of Phase II meeting with the FDA. The meeting focused on BriaCell’s lead clinical candidate, Bria-IMT™, in combination with a checkpoint inhibitor, which has been granted Fast Track designation for advanced metastatic breast cancer – a major milestone in the development of cancer treatments.
The successful completion of this study could potentially open the door to a new combination therapy for advanced metastatic breast cancer patients. A Biologics License Application (BLA) submission could pave the way for commercialization of this revolutionary treatment, offering hope and a brighter future to many.
We are thrilled to have reached a major milestone in our journey to become a leading immuno-oncology company: receiving Fast Track status for our lead clinical program. This expedites our timetable to potentially commercialize our novel immunotherapy approach, giving hope to women with no approved treatment options. We are excited to move directly into a pivotal study and take one step closer to our goal.
About BriaCell Therapeutics Corp.
BriaCell is revolutionizing cancer treatment with their cutting-edge immuno-oncology solutions. By targeting cancer cells with precision and effectiveness, they are paving the way for a brighter future in cancer management.
SAFE HARBOR
BriaCell Therapeutics Corp. is pleased to announce that it is undertaking a pivotal clinical study as a potential pathway to make a Biologics License Application for the approval of the combination regimen. This exciting development carries a range of risks and uncertainties that should be taken into account. As such, the Company has outlined these risks and uncertainties in their Management’s Discussion and Analysis, Annual Information Form, and other filings with the Canadian and U.S. Securities and Exchange Commissions. We are eager to move forward with this study and anticipate great progress in the future.