Life Science News

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.

Under the terms of the agreement, BriaCell gains the worldwide rights to develop and commercialize sCD80, while UMBC maintains ownership of the patents. BriaCell will pay royalties to UMBC upon the commercialization of the product plus patent management costs. The licensing agreement was coordinated by UMBC's Office of Technology Development.

"Our mission has been to develop safe and effective treatments for cancer patients who do not respond to existing treatments, and a transformational anti-cancer agent such as sCD80 may provide us with such an additional opportunity," stated Dr. Bill Williams, BriaCell's President and CEO. "Based on the promising data in animal studies, we plan to explore the potential use of sCD80 technology as a therapeutic agent in combination with our other immunotherapies or on its own. We look forward to accelerating the development of this novel anti-cancer agent to bring hope to patients who need it the most."

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 the potential for development and commercialization of sCD80 as a biologic agent for the treatment of cancer, and the possibility that sCD80 may awaken and boost the immune system to recognize and destroy tumor cells. 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 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 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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BCT:CA
BriaCell Partners with Waisman Biomanufacturing to Manufacture and Supply Prostate Cancer Immunotherapy

BriaCell Partners with Waisman Biomanufacturing to Manufacture and Supply Prostate Cancer Immunotherapy

  • 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.

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BriaCell Enters Research Agreement to Identify Novel Targets for Cancer Treatment

BriaCell Enters Research Agreement to Identify Novel Targets for Cancer Treatment

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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).

The Fast Track designation will apply to patients with metastatic breast cancer. BriaCell is developing Bria-IMT™ in combination with immune checkpoint inhibitors in a clinical trial listed in ClinicalTrials.gov as NCT03328026 . BriaCell is currently enrolling and dosing advanced breast cancer patients in its Phase I/IIa combination study of Bria-IMT™ with Incyte's checkpoint inhibitor, retifanlimab, and its immunomodulator, epacadostat under corporate collaboration with Incyte.

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There were no reservations in the Former Auditor's audit reports for any financial period during which the Former Auditor was the Company's auditor. There are no "reportable events" (as the term is defined in National Instrument 51-102 - Continuous Disclosure Obligations) between the Company and the Former Auditor. In accordance with National Instrument 51-102, the Notice of Change of Auditor, together with the required letters from the Former Auditor and the Successor Auditor, have been reviewed by the Company's audit committee and board of directors and filed on SEDAR.

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