BCT BriaCell Therapeutics Corp

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, will be highlighting its positive overall survival and clinical benefit data in metastatic breast cancer (MBC) patients including those with CNS metastasis (not shown on the abstracts) who were treated with the Bria-IMT™ plus immune checkpoint inhibitor (CPI) combination in its “Spotlight” poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX.

“In the Phase 2 study, the Bria-IMT™ combination regimen significantly increased overall survival versus comparable published benchmarks. Additionally, objective response rate and clinical benefit rate data, support the potential benefit of Bria-IMT™ plus CPI in patients with this difficult-to-treat cancer,” stated Saranya Chumsri, MD, Principal Investigator, and Professor of Oncology, Mayo Clinic. “We plan to confirm the impressive clinical data in the BriaCell pivotal Phase 3 study as we continue to explore the use of Bria-IMT™ regimen across all breast cancer subtypes.”

“At BriaCell, we are committed to finding therapeutic options for difficult-to-treat metastatic breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO. “BriaCell’s clinical data demonstrating impressive overall survival in all patient subsets including very difficult to treat patient populations, such as those who have failed prior checkpoint inhibitor and/or antibody-drug conjugate therapy, reinforces our confidence in the potential use of the combination regimen in MBC patients. Additionally, clinical benefit was seen across metastatic breast cancer subtypes including HER2+, HR+/HER2-, and even in triple-negative breast cancer (TNBC) patients. Bria-IMT™ may provide a significant contribution to the lives of patients and their families fighting this incurable disease.”

The details about the submitted abstracts are as follows:

Abstract Number: SESS-1071 (Selected as Spotlight Poster)Title: Overall survival results of Bria-IMT allogenic whole cell-based cancer vaccineTime: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CSTPresentation ID: PS3-06

Abstract Summary:

• 54 patients were enrolled with 22 patients in phase 1 and 32 patients in phase 2.
• 11 patients were treated with pembrolizumab and 44 patients with retifanlimab (1 patient received pembrolizumab and later retifanlimab).
• The Bria-IMT™ combination regimen was well tolerated.
• The Bria-IMT™ regimen demonstrated promising results across all subtypes of breast cancer with favorable safety profiles.
• Patients receiving the pivotal Phase 3 Bria-IMT™ combination regimen (n=37) showed significantly higher median overall survival (OS) (13.4), an objective response rate (ORR) of 9.5% and a clinical benefit rate (CBR) of 55%.
• Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive.
• Among 36 patients with post-dose cancer-associated circulating tumor cell (CTC) data, patients with post-dose CTC count < 5 had a significantly better OS compared with a CTC count > 5 (13.4 vs. 5.5 months, P 0.01).
• Patients with positive delayed type hypersensitivity (DTH), an inflammatory marker to measure the response to Bria-IMT™ immunization, had significantly better OS.

“Our clinical findings support the use of the current Phase 3 formulation,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We plan to confirm the potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study (NCT06072612) in metastatic breast cancer.”

Abstract Number: SESS-1431Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccinesTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-06-02

Abstract Number: SESS-2217Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysisTime: Wednesday, December 11, 2024 12:00 – 2:00 PM CSTPresentation ID: P1-01-17

Abstract Number: SESS-1068Abstract Title: ASTRO-VAC CNS: Bria-IMT in the management of tumor agnostic metastatic CNS lesionsTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-10-24

Abstract Number: SESS-1069Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancerTime: Friday, December 13, 2024 12:00 PM – 2:00 PM CSTPresentation ID: P5-10-12

Following presentations, the posters can be viewed at the following: https://briacell.com/scientific-publications/.

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 BriaCell’s potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study; BriaCell’s potential use of the combination regimen in MBC patients; BriaCell conducting a poster presentation at the 2024 San Antonio Breast Cancer Symposium®, and the contents of such presentation; the potential benefit of Bria-IMT™ plus CPI in cancer patients; BriaCell’s plans to confirm the clinical data in their pivotal Phase 3 study; BriaCell’s Phase 3 study exploring the use of the Bria-IMT™ regimen across all breast cancer subtypes; and the Bria-IMT™ regimen having the potential to provide a significant contribution to the lives of cancer patients 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