BriaCell Awarded $2 Million NCI Grant to Advance Bria-PROS+ in Prostate Cancer

BriaCell Awarded $2 Million NCI Grant to Advance Bria-PROS+ in Prostate Cancer

  • US$2,054,651 non-dilutive grant from the US National Cancer Institute to complete manufacturing of Bria-Pros+ TM clinical supply and support Phase 1/2a trial in metastatic prostate cancer
  • Expands Bria-OTS+ novel personalized off-the-shelf immunotherapy platform to prostate cancer, an urgent unmet medical need
  • Principal Investigator: Dr. William Oh, MD, Yale Cancer Center

briacell therapeutics corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (" BriaCell " or the " Company "), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce that the National Cancer Institute (NCI), the United States federal government's principal agency for cancer research and training, has awarded the Company a research grant of $2,054,651 to advance Bria-PROS+, BriaCell's next generation personalized off-the-shelf immunotherapy for prostate cancer.

The non-dilutive grant, titled "Phase 1/2a clinical trial to investigate Bria-PROS+™ in patients with metastatic prostate cancer", will be used to complete manufacturing of Bria-PROS+ and to fund the upcoming Phase 1/2a study in patients with advanced prostate cancer.

"Despite recent advances in the management of metastatic hormone-sensitive prostate cancer, most patients will progress with significant pain and suffering and limited treatment options," stated Dr. William Oh, MD, Director of Precision Medicine, Yale Cancer Center, and Principal Investigator on the upcoming Phase 1/2a clinical study of Bria-PROS+ in advanced prostate cancer. "We are grateful to the NCI for recognizing the urgency for this unmet medical need and supporting BriaCell's breakthrough immunotherapy."

"This prestigious award will help expedite the clinical development of Bria-PROS+ and is significant validation of our next generation novel personalized immunotherapy approach," added Dr. William V. Williams, BriaCell's President and CEO.

"The Bria-OTS+ platform was designed to overcome the complexity, cost and delays of traditional personalized cancer treatments," noted Miguel Lopez-Lago, PhD, BriaCell's Chief Scientific Officer. "We believe it will constitute a significant advancement in personalized cancer care."

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 the completion of manufacturing of Bria-PROS+; the outcome of the Phase 1/2a clinical trial in metastatic breast cancer; and the ongoing development of Bria-PROS+. 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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  • 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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  • 21 out of 29 patients treated since 2022 are still alive suggesting a strong survival benefit for BriaCell's combination regimen
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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, 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.

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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, 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 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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