BriaCell Presents Benchmark Beating Survival and Clinical Benefit at AACR 2025; Advancements in Next Generation Bria-OTS+(TM) Development

On April 28, 2025 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 positive data from its Phase 2 study of lead product candidate, Bria-IMT, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL (Press release, BriaCell Therapeutics, APR 28, 2025, View Source [SID1234652433]). In addition, Phase 3 early biomarker data will be presented as a late breaking abstract.

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The posters are summarized below and linked here: View Source

Title: Survival outcomes in a randomized phase 2 of Bria-IMT : An allogeneic whole cell cancer vaccine
Session Title: Phase II and Phase III Clinical Trials
Session Start: 4/28/2025 2:00 PM – 5:00 PM CST
Location: Poster Section 50
Poster Board Number: 18
Abstract Presentation Number: CT100

"The excellent survival responses reported in patients with different tumor types in the Phase 2 study is very exciting, and we look forward to seeing these promising data replicate in the pivotal Phase 3 study," stated Dr. William V. Williams, BriaCell’s President & CEO.

Of 54 metastatic breast cancer patients in the Phase 2 study, 37 patients received Bria-IMT formulation that is currently being used in BriaCell’s ongoing pivotal Phase 3 study (ClinicalTrials.gov as NCT06072612 ). Patients have been heavily pre-treated a median of 6 prior treatments — including Antibody-Drug Conjugates (ADCs) and check point inhibitors (CPIs).

Clinical benefit rates [CR, PR, SD] ranged from 45% to 100% based on subtype
Decrease in size or no change in all tumors noted in 83% of patients receiving Phase 3 formulation
Overall survival (OS) with the Phase 3 formulation was 17.3 months for HR+ patients and 11.44 months for patients with triple negative breast cancer (TNBC)
Overall response rate (ORR) for patients with intracranial metastases was 50% with a 75% clinical benefit rate
Safety profile: No unexpected adverse events, no treatment related discontinuation of therapy
Title: Bria-OTS+: A versatile therapeutic platform for inducing anti-cancer immunity
Session Category: Immunology
Session Title: Vaccines, In Situ Vaccines, and Vaccine Combinations
Session Date and Time: 4/28/2025 2:00 – 5:00 PM CST
Location: Poster Section 39
Poster Board Number: 29
Published Abstract Number: 3553

Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer, commented, "We are very excited with the anti-cancer activity of Bria-OTS+ and expect the platform will enable the delivery of powerful and long-lasting immune activity against cancer."

"This data further validates the mechanism of action of our next-generation Bria-OTS+ platform. Additional immune activating factors are expected to enhance efficacy, and we look forward to replicating these results clinically as we advance our next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs," stated Dr. William V. Williams, BriaCell’s President and CEO.

Bria-OTS+ is an immunotherapy platform and enhanced version of Bria-OTS, BriaCell’s personalized pre-manufactured immunotherapy already demonstrating tremendous results as announced on April 24 2025 . Bria-OTS+ immunotherapy expresses multiple immune-activating cytokines and co-stimulatory molecules in addition to immune-boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer are expected to be investigated in BriaCell’s upcoming Phase 1/2a clinical studies.