Life Science News

  • Extended survival and tumor shrinkage in advanced breast cancer patients who matched the immunotherapy HLA types, lead to the development of BriaCell's prostate cancer program based on the patient's HLA type.
  • Bria-Pros™ is a novel off-the-shelf personalized immunotherapy approach to treating prostate cancer.
  • Waisman Biomanufacturing has entered an agreement with BriaCell to manufacture clinical supplies for BriaCell's anticipated clinical trial in advanced prostate cancer.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, has entered a manufacturing service agreement with Waisman Biomanufacturing at the University of Wisconsin–Madison (Waisman), to manufacture Bria-Pros™, BriaCell's off-the-shelf personalized immunotherapy for prostate cancer, for anticipated use in clinical studies. Waisman is a leading contract manufacturing organization (CMO) with experience in the manufacturing of cellular therapies for clinical trials.

Under the terms of the agreement, Waisman will be responsible for good manufacturing practice (GMP) manufacturing of Bria-Pros™ for anticipated use in clinical studies. Waisman's expert team will be working closely with BriaCell's scientific and product development teams to ensure timely production of Bria-Pros™ in compliance with applicable regulatory requirements by the FDA.

Bria-Pros™ is a novel off-the-shelf personalized immunotherapy for prostate cancer. It includes multiple Human leukocyte antigen (HLA)-specific immunotherapy cell lines that will be administered to patients based on each patient's HLA type. BriaCell has been developing Bria-Pros™ as a potentially safe and effective personalized immunotherapy treatment for advanced prostate cancer.

BriaCell's Phase I/II trial in prostate cancer is expected to follow upon the completion of the manufacturing, testing, and the related regulatory filings.

"We are very excited to partner with the scientists and experts at Waisman, a leading CMO with extensive experience in the manufacturing of clinical grade cellular therapies, to ensure the rapid production of high-quality immunotherapy supplies for our upcoming clinical trial in prostate cancer. Additionally, this agreement will provide a starting point for our future service agreements as we expand our personalized immunotherapy pipeline into other cancer fields," stated Dr. Williams, BriaCell's President & CEO. "We believe that our novel off-the-shelf personalized immunotherapy may offer a safe and effective targeted personalized treatment option for advanced prostate cancer patients who failed the current standard of care," Dr. Williams added.

According to 2022 Cancer Facts & Figures , prostate cancer, aside from lung cancer, is the most common cancer among men. With an estimated 268,490 new cases diagnosed, 34,500 of men are expected to die of prostate cancer in 2022 making it the second leading cause of cancer death among men. Current treatments for metastatic prostate cancer include immunotherapy, hormone therapy, chemotherapy and targeted treatments. However, none of these treatments are curative. Novel approaches are needed for advanced prostate cancer.

About Waisman Biomanufacturing

With its state-of-art production facility in Madison, WI, and its expert personnel, Waisman Biomanufacturing has become a leading GMP contract manufacturing organization (CMO) which manufactures a wide range of biotherapeutics for clinical trials. The products include gene therapies, cell therapeutics, and both therapeutic and prophylactic vaccines. More information is available at: https://gmpbio.org .

About BriaCell Therapeutics Corp.

BriaCell is an immuno-oncology focused biotechnology company developing targeted and effective approaches for the management of cancer. 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. Examples of forward-looking statements in this news release include, among others, statements that the Company makes regarding: (i) the timely production of Bria-Pros™ in compliance with applicable regulatory requirements by the FDA; (ii) the timing, occurrence, and results of BriaCell's Phase I/II clinical trials in prostate cancer; (iii) any expected outcomes of BriaCell's contract with Waisman; and (iv) the potential to develop a safe and effective immunotherapy for advanced prostate cancer. Forward-looking 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 our 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 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 Secures License for a Promising Novel Anti-Cancer Agent

BriaCell Secures License for a Promising Novel Anti-Cancer Agent

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announces that it has secured an exclusive license from University of Maryland, Baltimore County (UMBC) to develop and commercialize Soluble CD80 (sCD80) as a biologic agent for the treatment of cancer.

The novel technology, originally developed by Suzanne Ostrand-Rosenberg, Ph.D., Emeritus Faculty at UMBC, and member of BriaCell's scientific advisory board, is titled "Soluble CD80 as a Therapeutic to Reverse Immune Suppression in Cancer Patients" and covered under USPN 8,956,619 B2 , USPN 9,650,429 B2 , and USPN 10,377,810 B2 . In animal models, sCD80 was well-tolerated and stopped tumor growth by potentially restoring natural anti-tumor immunity (see Lucas A Horn, et al . and Samuel T Haile et al. in collaboration with Dr. Ostrand-Rosenberg). Additionally, strong anti-tumor activity of sCD80 has been reported in multiple tumor types (see Lucas A Horn, et al .). Importantly, as demonstrated in the same studies, sCD80's unique actions may involve both awakening and boosting the immune system to recognize and destroy tumor cells.

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The research collaboration will focus on the discovery and development of novel targets to enhance tumor cell responsiveness to chemotherapy and immunotherapies in specific cancers including lung, head and neck, cervical, and bladder cancers. The research team at Harvard Medical School is led by Joan S. Brugge, PhD, who is the Louise Foote Pfeiffer Professor of Cell Biology and Co-Director of the Ludwig Cancer Center.

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BriaCell Anti-Cancer Technology Published in Leading Cancer Drug Discovery Journal

BriaCell Anti-Cancer Technology Published in Leading Cancer Drug Discovery Journal

  • Anti-Cancer activity of BriaCell's lead candidate, Bria-IMT™, in advanced breast cancer patients was published in a leading peer-reviewed publication.
  • Bria-IMT™, through a novel mechanism of action, rapidly destroyed tumors in patients who matched Bria-IMT™ HLA types, supporting BriaCell's platform strategy of developing off-the-shelf personalized immunotherapy for multiple cancer indications.
  • The clinical data, previously reported, included rapid tumor reduction and extended survival.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is pleased to announce the publication of novel scientific data and clinical data (previously reported) on BriaCell's lead candidate, Bria-IMT™. The abstract of the paper was published on-line in Recent Patents on Anti-Cancer Drug Discovery a publication focused on research (where patents have been registered) in leading therapeutic areas, targets, and agents related to anti-cancer drug discovery. The publication highlights BriaCell's approach to developing novel cellular immunotherapies for cancer and the safety and efficacy of Bria-IMT™ against advanced breast cancer in a prior clinical study through a potentially unique mechanism of action. The full text of the article will be made available.

"We are thrilled to see the congruence of our scientific insights and the clinical activity of our immunotherapy in advanced breast cancer patients," stated Dr. Williams, BriaCell's President & CEO. "This paper highlights our findings of rapid tumor shrinkage in multiple anatomic locations including difficult to treat sites like the brain. We are even more excited to see the potential positive effect on survival in these patients. Having these scientific and clinical findings published in such a highly regarded journal is a significant achievement for BriaCell. The results support our approach for selecting patients most likely to benefit from our immunotherapy. This undergirds our current strategy of building a pipeline of off-the-shelf personalized immunotherapies as potentially safe and effective treatments for advanced breast cancer and other cancers," Dr. Williams added.

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BriaCell Adds Additional Clinical Sites to Broaden Patient Access and Further Boost Enrollment

BriaCell Adds Additional Clinical Sites to Broaden Patient Access and Further Boost Enrollment

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, announces that it has activated Hoag Memorial Hospital Presbyterian ("Hoag") and re-engaged Sylvester Comprehensive Cancer Center, part of UHealth the University of Miami Health System, as two additional clinical sites for the screening and enrollment of advanced breast cancer patients in the Phase IIIa combination study of BriaCell's lead candidate, Bria-IMT™, with Incyte's checkpoint inhibitor, retifanlimab, and its immunomodulator, epacadostat.

"While we continue to steadily accrue patients in our ongoing clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors, the addition of these clinical sites should help further accelerate patient enrollment in the clinical trial. We look forward to discussing our safety and efficacy data with the FDA, now with Fast Track status , to plan our pivotal registration study and remain on track to achieve this major milestone in 2022," stated Dr. Bill Williams, BriaCell's President & CEO.

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BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy

BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy

  • U.S. Food and Drug Administration (FDA) has granted Fast Track status to BriaCell's lead candidate, Bria-IMT™, for the treatment of metastatic breast cancer.
  • Fast Track improves the speed and frequency of communication with FDA, potentially leading to earlier drug approval and access by patients.
  • BriaCell is currently enrolling and dosing advanced breast cancer patients in a Phase I/IIa study, now with Fast Track designation.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to BriaCell's lead candidate, Bria-IMT™, for the treatment of metastatic breast cancer (breast cancer that has spread beyond the breast).

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About dynaCERT Inc.
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