Dr. William Williams reports

BREAKING GROUND IN PROSTATE CANCER: BRIACELL ANNOUNCES LEAD PROSTATE CANCER CANDIDATE BRIA-PROS+, INITIATES GMP MANUFACTURING

Briacell Therapeutics Corp. has initiated good manufacturing practice (GMP) manufacturing of its lead candidate for treating prostate cancer, Bria-Pros+. GMP manufacturing of Bria-Pros+ will provide clinical supplies for planned clinical trial use.

"Building upon the compelling preclinical proof-of-concept data presented at the Society for the Immunotherapy of Cancer (SITC) meeting in 2023, Briacell's proprietary platform technology holds significant potential to benefit patients across a spectrum of cancers. We are enthusiastic about commencing GMP manufacturing for our prostate cancer clinical candidate, continuing our efforts at transforming targeted cancer therapy via the introduction of potent personalized cellular cancer vaccines," stated Dr. William V. Williams, Briacell's president and chief executive officer. "The successful development of this first candidate showcases our capacity to create novel cancer immunotherapies and advance them towards clinical application. We eagerly anticipate completing investigational new drug (IND) enabling studies during 2024 with Bria-Pros+."

Recently presented at SITC 2023, the preclinical proof-of-concept data demonstrated both feasibility and efficacy of Briacell's platform of cellular cancer vaccines over all, with specific emphasis on Bria-Pros+. Briacell genetically engineers cancer cell lines to produce cytokines and co-stimulatory factors that significantly increase immune stimulation compared with the unmodified (parent) cancer cell lines. These cell lines also express patient-specific human leukocyte antigens (HLA) alleles and potentially provide personalized off-the-shelf treatment.

In the realm of cancer immunotherapy, the objective is to restore the body's natural anti-tumour immunity. Despite notable progress, current approaches often fall short of achieving curative outcomes, primarily because they target specific immune processes, resulting in only partial restoration of the body's inherent anti-cancer immunity.

An optimal cancer immunotherapy should initiate or reinstate a persistent anti-tumour immune response through both complementary and diverse mechanisms, resulting in a self-sustaining cycle of cancer immunity by both the innate and adaptive immune responses. The data highlighted at the SITC meeting demonstrated that Bria-Pros+ could effectively activate the natural immune response against tumour cells by both expressing cancer antigens and by modulating the activity of innate and adaptive immune cells. These include helper T cells (CD4+), cytotoxic (killer) T cells (CD8+) and natural killer cells (both classical NK cells and NKT cells). Data previously presented at the SITC meeting are reproduced here in a different format.

In summary, the company's data suggest significantly stronger anti-tumour activity for Bria-Pros+ versus that of the parent cells, making it an ideal lead clinical candidate for the company's coming clinical studies in prostate cancer.

According to the 2024 Cancer Facts & Figures report, prostate cancer is projected to be the most common cancer among men in 2024. With 299,010 new cases estimated to be diagnosed in 2024 and 35,250 projected deaths from prostate cancer in 2024, prostate cancer is expected to be the second-leading cause of cancer death among men in 2024. Current treatments for metastatic prostate cancer include immunotherapy, hormone therapy, chemotherapy and targeted treatments. Novel approaches are needed for advanced prostate cancer.

About Briacell Therapeutics Corp.

Briacell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care.

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