- BriaCell has received agreement and positive feedback from its End of Phase II meeting with the FDA for lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor, in advanced metastatic breast cancer.
- After reviewing BriaCell’s Fast Track designated Phase I / IIa data, the FDA has agreed on the primary end point, the essential elements of the pivotal registration study design, and type of patients to be included.
- Registration study success could lead to a Biologics License Application (BLA) submission and commercialization approvals for BriaCell’s novel immunotherapy approach.
PHILADELPHIA and VANCOUVER, British Columbia,, Jan. 18, 2023 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is pleased to announce that it has received agreement and positive feedback from its End of Phase II meeting with the FDA regarding BriaCell’s lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor (under Fast Track designation), in advanced metastatic breast cancer.
BriaCell and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled in BriaCell’s upcoming pivotal clinical study. This pivotal registration study will be enrolling advanced metastatic breast cancer patients for whom no approved treatment options exist.
Registration study success could lead to a Biologics License Application (BLA) submission for the approval of the combination regimen for commercialization in advanced metastatic breast cancer.
“The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Jumping directly into a pivotal study shortly after receiving Fast Track status has greatly advanced our lead clinical program timetable with the ultimate goal of commercializing our novel immunotherapy approach for women with no approved treatment options.”
About BriaCell Therapeutics Corp.
BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. More information is available at https://briacell.com/ .
Safe Harbor
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Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
[email protected]
Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
[email protected]
Investor Relations Contact:
CORE IR
[email protected]