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, is thrilled to announce continued outstanding topline survival and clinical benefit data in advanced metastatic breast cancer patients treated Bria-IMT™ in combination with an immune check point inhibitor (CPI). The data is being revealed at the 2023 San Antonio Breast Cancer Symposium® held at Henry B. Gonzalez Convention Center, San Antonio, TX.

“The survival data in this heavily pre-treated advanced metastatic breast cancer patients looks very promising and we are looking forward to validate these findings in the PREVAIL trial “Importantly, the favorable safety profile makes the novel treatment regimen an attractive choice for patients who are heavily pre-treated and often cannot tolerate the harsh side effects of other therapies.” stated Carmen Calfa, M.D., Clinical Research Lead for the breast site disease group at the University of Miami Miller School of Medicine, Co-Director of the Cancer Survivorship Program at Sylvester Comprehensive Cancer Center, and Principal Clinical Investigator of the Phase 2 Bria-IMT™ study.

Abstract Title: Randomized Phase 2 of Bria-IMT™, an Allogenic Human Cell Line with Antigen Presenting Activity, in Heavily Pretreated Metastatic Breast CancerSubmission ID: 1580375Presentation ID: PO3-05-12Spotlight Session: Poster Session 3Session Date and Time: Thursday December 7, 2023 12:00 PM - 2:00 PM CT

Phase 2 Combination Study of Bria-IMT™ with Immune Check Point Inhibitor

• The Phase 2 study is fully enrolled.
• An aggregate of 54 advanced metastatic breast cancer patients have been enrolled in the study {11 patients with KEYTRUDA® (pembrolizumab), and 43 patients with Incyte’s retifanlimab with one patient cross over from the KEYTRUDA® study to retifanlimab study}.
• Data is available on 48 of these heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6).

Excellent Overall Survival and Tolerability:

• Interim analysis using Kaplan-Meier curve method, measuring the probability of patients’ survival in time, showed median overall survival (OS) of 13.4 months for 54 patients. This is a marked improvement over the benchmark 6.7-9.8 months reported in similar (third line or higher) patients*.
• 32 out of 42 patients that have received treatment since 2022 remain alive, suggesting tolerability and survival efficacy. The data will continue to mature as patients remain on the study.
• All patients were able to receive therapy with no toxicity related discontinuations.

Immune Response:

• In certain instances, BriaCell’s combination regimen turned “cold” breast cancer tumors “hot” and activated the patient’s cancer fighting immune system cells including CD8+ tumor infiltrating lymphocytes.
• BriaCell’s regimen reversed immune exhaustion in several heavily pre-treated patients who had failed prior CPI treatments suggesting potentially better clinical and survival outcomes in these patients.
• Bria-IMT™ before CPI showed a prolonged reduction in Neutrophil to Lymphocyte Ratio (NLR), a significant predictor of clinical benefit in patients, and this optimized sequence is in use in the current pivotal Phase 3 study (NCT06072612).

In summary, the consistent topline survival and clinical benefits support BriaCell’s hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT™ and support the ongoing pivotal study of our combination regimen in the treatment of advanced metastatic breast cancer.

To view the poster, please visit https://briacell.com/scientific-publications/.

*Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022

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 presented at the scientific conference, 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.sedar.com 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.

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Contact Information

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

Media Relations:Jules AbrahamDirector of Public RelationsCORE IR917-885-7378julesa@coreir.com

Investor Relations Contact:CORE IRinvestors@briacell.com