BriaCell's Bria-OTS+ Mechanism of Action Validated in Highly Rated Peer Reviewed Cancer Journal

BriaCell's Bria-OTS+ Mechanism of Action Validated in Highly Rated Peer Reviewed Cancer Journal

  • Data from BriaCell and the US National Cancer Institute (NCI) support the cancer cell killing potential of BriaCell's Bria-OTS+ platform
  • Bria-OTS+, a novel personalized, off-the-shelf, semi-allogeneic cellular immunotherapy may address urgent unmet medical needs for patients with cancer
  • This study was conducted in collaboration with the NCI

briacell therapeutics corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (" BriaCell " or the " Company "), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announced the publication of the mechanism of action of its next generation personalized off-the-shelf immunotherapy. This research conducted in collaboration with the National Cancer Institute (NCI), the US federal government's principal agency for cancer research and training, has been published at JCI Insight, a highly rated peer-reviewed journal dedicated to advancing biomedical research from preclinical discovery through to clinical development.

Publication Title: Enhancing dendritic cell cancer vaccine by allogeneic MHC class II expression and Treg depletion (our reference 189024-INS-RG-RV-4)

"These findings help us better understand the anti-tumor effects of Bria-OTS+ in cancer patients," stated Jay A. Berzofsky, MD, PhD, Senior Investigator of NCI and coauthor of the publication. "The study demonstrated that semi-allogeneic dendritic-cell vaccines recruit alloreactive CD4⁺ T-cell help through mismatched MHC class II molecules, which in turn strengthens antigen-specific CD8⁺ T-cell responses against tumors."

"This publication validates the core design principle behind Bria-OTS+: partial HLA matching enables effective tumor-antigen presentation, while planned HLA mismatching drives robust CD4⁺ helper responses," noted Miguel Lopez-Lago, PhD, BriaCell's Chief Scientific Officer. "These findings are directly aligned with BriaCell's pipeline of allogeneic immunotherapies, reinforcing our strategy to deliver powerful and scalable treatments for cancer patients."

"These data are consistent with the encouraging clinical results we recently reported in our Phase 1/2a study in metastatic breast cancer and provide important insights into the mechanism of action of our cellular immunotherapy platform technology," added Dr. William V. Williams, BriaCell's President and CEO.

For the copy of the publication, please visit: https://briacell.com/scientific-publications/ .

About Bria-OTS

Bria-OTS is a next generation, off-the-shelf personalized immunotherapy based on BriaCell's lead candidate Bria-IMT currently being evaluated in a Phase 1/2a study (ClinicalTrials.gov identifier: NCT06471673 ) in patients with metastatic recurrent breast cancer. The trial includes both monotherapy dose escalation and check point inhibition combination dose expansion cohorts. The Company recently progressed into the dose expansion phase.

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 include statements regarding Bria-OTS+'s potential to address urgent unmet medical needs for patients with cancer; and BriaCell delivering powerful and scalable treatments for cancer patients. These statements 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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Developing Personalized Off-The-Shelf Immunotherapy Treatments for Cancer Patients

BriaCell Partners with New York Cancer & Blood Specialists  for Pivotal Phase 3 Study of Bria-IMT in Advanced Breast Cancer

BriaCell Partners with New York Cancer & Blood Specialists for Pivotal Phase 3 Study of Bria-IMT in Advanced Breast Cancer

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 pleased to announce a partnership with New York Cancer & Blood Specialists (NYCBS), a group of leading community cancer centers in the United States, to evaluate the Bria-IMT™ combination with a checkpoint inhibitor in its pivotal Phase 3 registration study in advanced breast cancer patients in New York.

"Cancer is complex. It takes a village to care for a cancer patient. At NYCBS, our mission is to offer cancer patients access to state-of-the-art treatments close to their homes, families, and support networks at convenient locations across Long Island, New York City, and Upstate New York," stated Dr. Jeffrey Vacirca, CEO of NYCBS. "We were impressed with the survival data of the Bria-IMT™ regimen to date and look forward to working with the BriaCell team to make these novel therapeutics available to our patients."

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BriaCell Initiates Pivotal Phase 3 Study of Bria-IMT in Advanced Metastatic Breast Cancer

BriaCell Initiates Pivotal Phase 3 Study of Bria-IMT in Advanced Metastatic Breast Cancer

  • The randomized pivotal Phase 3 study is expected to enroll a total of 354 patients in either Bria-IMT™ combination or physician's choice therapy (1:1)
  • Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT™
  • The study's primary endpoint is overall survival in patients treated with the Bria-IMT™ combination regimen versus those treated with physician's choice
  • The study initiation follows FDA Fast Track designation and earlier supportive Phase 2 safety and efficacy data in the same patient population

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 announces that its registration-enabling pivotal Phase 3 study of its lead clinical candidate, Bria-IMT™, in combination with an immune check point inhibitor, is fully approved by the Institutional Review Board (IRB) and will soon enroll patients with advanced metastatic breast cancer.

"Timely initiation of our pivotal study is a key milestone for us further confirming our expedited timeline for FDA approval of our immunotherapy," stated Dr. William V. Williams, BriaCell's President and CEO. "Based on our recently announced benchmark beating survival data, we strongly believe that our novel immunotherapy may transform the way we treat advanced metastatic breast cancer patients, and we look forward to sharing additional development milestones in the coming months."

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BriaCell Reports Benchmark-Beating Patient Survival and Clinical Benefit in Advanced Metastatic Breast Cancer

BriaCell Reports Benchmark-Beating Patient Survival and Clinical Benefit in Advanced Metastatic Breast Cancer

  • Median overall survival of 13.5 months in BriaCell's advanced metastatic breast cancer patients (vs. 6.7-9.8 months for similar patients reported in the literature)
  • 21 out of 29 patients treated since 2022 are still alive suggesting a strong survival benefit for BriaCell's combination regimen
  • No dose limiting toxicities to date

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 announces the completion of patient enrollment in its Phase 2 clinical study and reports clinical data showing strong patient survival benefit and clinical benefit in advanced metastatic breast cancer patients.

"The promising survival data of BriaCell's combination regimen suggests the potential for an industry-shaping leap in advanced metastatic breast cancer treatment," stated Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at the University of Miami, Associate Professor of Clinical Medicine, and Principal Clinical Investigator of the Phase 2 Bria-IMT™ plus check point inhibitors study. "The overall safety profile and survival data in advanced metastatic breast cancer is extremely encouraging in this heavily pre-treated patient population."

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BriaCell Therapeutics Corp. Announces Closing of Plan of Arrangement Spinning Out BriaPro Therapeutics Corp. to Existing Shareholders

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 announces that the Company has closed the previously announced plan of arrangement spinout transaction (the " Arrangement ") pursuant to which certain pipeline assets of the Company, including Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the " SpinCo Assets "), were spun-out to BriaPro Therapeutics Corp. (" SpinCo "), resulting in a 23 rd owned subsidiary of the Company with the remaining 13 rd held by BriaCell shareholders (" BriaCell Shareholders ").

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BriaCell Accepts Letter of Intent from Weill Cornell Medicine Outlining Plans to Initiate a Clinical Trial of Bria-IMT in High-Risk Early-Stage Triple Negative Breast Cancer

BriaCell Accepts Letter of Intent from Weill Cornell Medicine Outlining Plans to Initiate a Clinical Trial of Bria-IMT in High-Risk Early-Stage Triple Negative Breast Cancer

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, announces that it has accepted a letter of intent from Dr. Massimo Cristofanilli, Director of Breast Medical Oncology and Associate Director of Precision Medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, outlining the parties' plans and commitment, upon regulatory approval, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell's novel immunotherapy, Bria-IMT™, in combination with a check point inhibitor (CPI), in early stage, newly diagnosed, high-risk triple negative breast cancer (TNBC) patients in the neoadjuvant setting.

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