BCTX BriaCell Therapeutics Corporation

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, today is pleased to report preclinical data showing strong anti-cancer activity of its next generation, personalized, off-the-shelf, cell-based breast and prostate cancer immunotherapies, Bria-BRES+™ and Bria-PROS+™, respectively, during a poster session at the 2024 Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, held November 6-10, 2024, in Houston, TX.

Bria-OTS+™ is an Off-The-Shelf (i.e. pre-manufactured and ready for use) cell-based personalized immunotherapy platform for cancer. First generation Bria-OTS™ immunotherapy is HLA matched to individual patients and expresses a variety of cancer-related antigens, including Tumor-Associated Antigens (TAAs) and Post-Translational Modifications (PTMs). Bria-OTS+™ further expresses multiple immune activating cytokines and co-stimulatory molecules in addition to immune boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). The Bria-OTS+™ platform technology includes both Bria-BRES+™ and Bria-PROS+™, expansions of the Bria-OTS™ program.

“Bria-OTS+™ represents a significant advancement in the fight against cancer, leveraging gene-modified allogeneic tumor cells as a comprehensive immunotherapeutic platform. This innovative approach is set to address major challenges in cancer therapy, including effective antigen selection, T-cell immune escape, and manufacturing complexities. The development of Bria-OTS+™ builds on the success of BriaCell's initial platform, Bria-IMT™, which has shown promising clinical results in metastatic breast cancer,” commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.

“We are thrilled with our pre-clinical data confirming the expected high potency and potential for long-lasting anti-tumor activity of our novel next-generation immunotherapy in multiple cancer models,” commented Dr. William V. Williams, BriaCell’s President and CEO. “We believe that activating both adaptive and innate immune systems is a novel and highly effective approach for cancer treatment and look forward to generating proof of concept data in our ongoing Phase 1/2 study of Bria-OTS™ in metastatic breast cancer, and other cancers.”

The poster is summarized below and linked here: https://briacell.com/scientific-publications/.

Title: Bria-OTS+™: A Cellular Cancer Vaccine Platform Targeting Innate and Adaptive ImmunityLocation: Exhibit Halls A B George R. Brown Convention Center, Houston, TX Date and Time: Friday, Nov. 8, 2024, 9:00 am -7:00 pm CST

Results:

• Both Bria-BRES+™ (clinical candidate for breast cancer) and Bria-PROS+™ (clinical candidate for prostate cancer) activated key components of the innate immune system, the body’s first line of defense against cancer, including Natural Killer (NK) cells and NKT cells in preclinical cancer models.
• Activation of the innate immune system by Bria-BRES+™ and Bria-PROS+™ was mediated by CD86, IL-12, NKG2D and inhibited by HLA class I molecules
• Bria-BRES+™ and Bria-PROS+™ both effectively activated immune cells to destroy breast cancer and prostate cancer cells in a pre-clinical cancer model
• Both Bria-BRES+™ and Bria-PROS+™ activated key adaptive immune responses demonstrating immunological memory and suggesting potent and durable anti-cancer effects in cancer patients

Conclusion:The characteristics of the next generation Bria-OTS+™ immunotherapy platform include the following:

• Engages multiple facets of the adaptive immune response
• Activates components of the innate immune system
• Specifically activates Natural Killer (NK) cells to offset cancer immune escape caused by the loss of human leukocyte antigens (HLA)
• Designed for both personalized and ready-to-use therapy with long-term stability
• Simplified intradermal administration (injection into the skin)
• Targeted mechanism of action expected drive high efficacy with a favorable side effect profile

“The preclinical data demonstrating targeted activation of both the innate and adaptive immune systems suggest potential efficacy and safety across multiple cancer indications,” stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women's Cancer Program. “Personalized off-the-shelf cancer immunotherapy is an especially exciting treatment modality that would benefit many cancer patients.”

BriaCell is currently conducting its Phase 1/2 Study of Bria-OTS™ (first generation product), also known as Bria-BRES™, in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06471673). This is a bucket trial with other cancer indications expected to be added soon. The next generation (Bria-OTS+™) is expected to enter the clinic in 1H2025 starting with Bria-PROS+™ for prostate cancer.

Bria-OTS+™ leverages advanced biomanufacturing techniques, ensuring scalability and cost-effectiveness, crucial for rapid global deployment. It is designed to target a range of cancer types and strong intellectual property strategy protects Bria-OTS+™ innovations and strengthens BriaCell’s competitive position. Bria-OTS+™ is designed as an open-ended, modular platform, allowing for continuous refinement and the addition of new components. This flexibility enables BriaCell to rapidly adapt to emerging scientific insights and therapeutic needs, ensuring long-term relevance and effectiveness.

About BriaCell Therapeutics Corp.

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.

Safe Harbor

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about Bria-OTS+™ addressing certain challenges in cancer therapy, such as effective antigen selection, T-cell immune escape, and manufacturing complexities; BriaCell generating proof of concept data in the ongoing Phase 1/2 study of Bria-OTS+™ in various cancers, such as metastatic breast cancer; the preclinical data of Bria-OTS+™ demonstrating potential efficacy and safety across multiple cancer indications; BriaCell’s personalized off-the-shelf immunotherapy benefiting many cancer patients; BriaCell continuing its clinical study investigations of its novel targeted immunotherapy candidates, including the addition of new cancer indications; and BriaCell’s anticipated timeline of clinical studies on Bria-OTS+™ and Bria-PROS+™, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com 

Media Relations:Jules AbrahamCORE IRjulesa@coreir.com

Investor Relations Contact:CORE IRinvestors@briacell.com