BriaCell Advances Personalized Melanoma Immunotherapy Vaccine Candidate, Bria-MEL+

BriaCell Advances Personalized Melanoma Immunotherapy Vaccine Candidate, Bria-MEL+

  • Cell-based immunotherapy program is designed to harness patients' own immune systems
  • Bria-MEL+ is a personalized, off-the-shelf immunotherapy vaccine candidate intended to enable patient specific treatment without individualized manufacturing
  • Program builds on BriaCell's experience in metastatic breast cancer and prostate cancer, further expanding its therapeutic vaccine platform
  • Melanoma remains a significant unmet medical need, with approximately 112,000 new cases and 8,510 deaths expected in the US in 2026

briacell therapeutics corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announced that Bria-MEL+, its personalized whole cell melanoma immunotherapy vaccine candidate, has achieved a key 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. The program is personalized yet ‘off-the-shelf': a simple patient saliva test will determine which of the several premanufactured treatment cell lines will be selected for personalized treatment, avoiding the need to manufacture a unique product for each individual patient.

"Bria-MEL+ is designed to combine the advantages of personalized immunotherapy with the accessibility of an off-the-shelf vaccine," said William V. Williams, MD, President and Chief Executive Officer of BriaCell. "By eliminating individualized manufacturing, we believe this approach has the potential to broaden access, shorten treatment timelines, and reduce treatment costs while preserving patient-specific matching."

"Building on the encouraging efficacy and tolerability results from BriaCell's metastatic breast cancer immunotherapy program, we continue to expand our pipeline with additional personalized, cell-based immunotherapy vaccine candidates, including Bria-MEL+ for melanoma," stated Miguel A. Lopez-Lago, PhD, BriaCell's Chief Scientific Officer.

About Bria-MEL+â„¢

Bria-MEL+ is a personalized, off-the-shelf, genetically modified whole-cell cancer vaccine designed to activate multiple components of the immune system, including innate and adaptive immune responses, to target and destroy melanoma cells. The program is derived from BriaCell's Bria-OTS+â„¢ (off-the-shelf) cellular immunotherapy platform and is being developed using premanufactured cell lines selected through patient HLA matching.

BriaCell's Bria-MEL+ expands the Company's personalized immunotherapy platform which is led by Bria-IMTâ„¢, currently in a pivotal Phase 3 trial for metastatic breast cancer. BriaCell is also advancing Bria-OTSâ„¢ in breast cancer, in which the first patient dosed experienced sustained complete resolution of a lung metastasis, and Bria-PROS+â„¢ in prostate cancer which has recently received FDA clearance to initiate clinical evaluation. The Bria-MEL+, Bria-PROS+ and Bria-OTS programs are based on matching patient HLA type with the corresponding immunotherapy cell line.

Earlier In 2026, BriaCell reported preclinical data from the Bria-OTS+ platform at the AACR Annual Meeting, Bria-OTS+ demonstrated activation of both adaptive and innate immunity, including naĂ¯ve/resting T cells, dendritic cells, and natural killer (NK) cells, inducing immune memory and eliciting "serial killer" activity against cancer cells. BriaCell believes this multipronged immune activation supports the potential of the Bria-OTS+ platform to generate anti-tumor immune responses and informs the development of Bria-MEL+ for melanoma.

BriaCell has commenced development activities to support production of Bria-MEL+ for potential clinical use. Bria-MEL+ recently passed a key milestone in the genetic engineering process, streamlining the path to the clinic.

Melanoma Facts

The American Cancer Society estimates that approximately 112,000 new cases of melanomas will be diagnosed in the United States in 2026, including about 65,400 in men and 46,600 in women. Based on 2021–2023 Surveillance, Epidemiology, and End Results (SEER) data, approximately 2.2% of men and women will be diagnosed with skin melanoma during their lifetime.

Despite major advances in treatment, melanoma remains a significant unmet medical need. Approximately 8510 people are expected to die from melanoma in the United States in 2026, including about 5500 men and 3010 women. Melanoma accounts for only about 1% of skin cancers but causes a large majority of skin cancer deaths.

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

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 regarding the development of Bria-MEL+, its potential clinical use in melanoma, its personalized off-the-shelf design and potential immune‑stimulating and anti‑tumor activity, the advancement of Bria-MEL+ toward clinical development, pipeline expansion leveraging BriaCell's oncology immunotherapy platform, and expectations regarding the potential clinical benefits of the Bria‑OTS+ platform, 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 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, MD
President & CEO
1-888-485-6340
info@briacell.com 

Investor Relations Contact:
investors@briacell.com


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