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."

"We are very honored to work with the team of medical and health specialists at one of the nation's leading cancer centers," stated Dr. Giuseppe Del Priore, BriaCell's Chief Medical Officer. "Their insights and dedication to excellent patient care will be of utmost importance to us in our upcoming pivotal registration study."

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/ .

About New York Cancer & Blood Specialists (NYCBS)

New York Cancer & Blood Specialists (NYCBS) is a leading oncology practice in the New York Metropolitan area committed to providing world-class, patient-centered affordable care to patients with cancer and blood disorders in their own communities, close to family and friends. NYCBS has more than 30 locations and 35 hospital affiliations throughout Nassau and Suffolk counties, in the Bronx, Manhattan, Queens, Staten Island, and Brooklyn. We offer a multidisciplinary and comprehensive approach to care that utilizes the most advanced imaging, state-of-the-art therapies, cutting-edge clinical trials, on-site pharmacies, and an in-house laboratory with a full range of pathology services. Advocating for and ensuring the health and well-being of our patients is and always will be our top priority. For more information, visit www.nycancer.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 in relation to the ability of the medical advisory board to assist the Company with its registration studies, developing novel immunotherapies and achieving desirable outcomes for advanced breast 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 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.

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

Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com

Investor Relations Contact:
CORE IR
investors@BriaCell.com


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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 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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