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BriaCell Announces Bria-MEL+ Achieves Genetic Engineering Milestone
BriaCell announced that Bria-MEL+, its personalized whole cell melanoma immunotherapy vaccine candidate, has achieved a genetic engineering milestone, advancing the program toward clinical development. Bria-MEL+ is a cell-based therapeutic cancer vaccine designed to harness a patient's own immune system to combat melanoma.
BriaCell Receives FDA Approval for Bria-PROS+ Clinical Evaluation
BriaCell Therapeutics announced that the FDA has completed its review of the Investigational New Drug application for Bria-PROS+ and issued a Study May Proceed letter, clearing the way for clinical evaluation of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for prostate cancer. Bria-PROS+ demonstrated activation of both adaptive and innate immune responses including activation of naive T-cells, dendritic cells and natural killer cells. In August 2025, BriaCell was awarded a $2M non-dilutive grant from the U.S. National Cancer Institute to support the manufacturing and planned clinical evaluation of Bria-PROS+.
BriaCell Announces Manufacturing Agreement with Fujifilm
BriaCell announced a manufacturing arrangement with Fujifilm Biotechnologies California, a contract development and manufacturing organization specializing in cell therapies, to support the ongoing pivotal Phase 3 clinical development and potential future commercial supply of BriaCell's lead clinical candidate, Bria-IMT, an off-the-shelf allogenic cell therapy.
BriaCell Signs MoU with Uneedle for Microneedle Technology
BriaCell has entered into a memorandum of understanding, or MoU, with Uneedle to support the continued use and commercial readiness of Uneedle's proprietary microneedle technology for intradermal administration of BriaCell's lead Phase 3 clinical candidate, Bria-IMT, for the treatment of metastatic breast cancer. The MoU reflects the continued commitment of BriaCell and Uneedle to collaborate on the potential regulatory and commercial development of BriaCell's cell-based immunotherapy Bria-IMT. The non-binding MoU is intended to establish a plan that details scaling of Uneedle's microneedle devices for use in commercial quantities. All activities and projections described herein are contingent upon successful regulatory approval of BriaCell's lead Phase 3 clinical candidate, Bria-IMT, in the relevant jurisdictions. Bria-IMT is currently being evaluated in BriaCell's ongoing pivotal Phase 3 study in advanced metastatic breast cancer. Uneedle's microneedle technology is being used in this pivotal study to intradermally administer Bria-IMT.
BriaCell Therapeutics Receives Sixth Positive Recommendation from DSMB
BriaCell Therapeutics announces that the independent Data Safety Monitoring Board, DSMB, has issued its sixth consecutive positive recommendation following review of safety data from BriaCell's Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor in patients with metastatic breast cancer. Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell's ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration, reflecting the significant unmet medical need in metastatic breast cancer.
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