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- Arrangement with FUJIFILM Biotechnologies California provides manufacturing capacity for the remainder of BriaCell's pivotal Phase 3 study and commercial scalability potentialÂ
- Bria-IMT is currently being evaluated in Bria-Cell's ongoing pivotal Phase 3 study in metastatic breast cancer
briacell therapeutics corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces a manufacturing arrangement with FUJIFILM Biotechnologies California, a leading contract development and manufacturing organization (CDMO) specializing in cell therapies, to support the ongoing pivotal Phase 3 clinical development and potential future commercial supply of BriaCell's lead clinical candidate, Bria-IMT, an off-the-shelf allogenic cell therapy.
Bria-IMT is currently being evaluated in BriaCell's pivotal Phase 3 study of Bria-IMT in combination with an immune checkpoint inhibitor in advanced metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612).
"Securing manufacturing capacity with Fujifilm, a global leader in cell therapy manufacturing, represents a key milestone in our Bria-IMT development and potential commercialization strategy as we work toward our goal of bringing this novel immunotherapy candidate to patients with metastatic breast cancer," said William V. Williams, MD, President and Chief Executive Officer of BriaCell.
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 FUJIFILM Biotechnologies California
FUJIFILM Biotechnologies California, a subsidiary of FUJIFILM Corporation, specializes in developing and manufacturing cell-based therapeutics. Located in Thousand Oaks, California, the company operates a state-of-the-art cell therapy manufacturing facility featuring cGMP production suites, quality control and development laboratories, and product storage and distribution capabilities. These facilities support both autologous and allogeneic cell therapy manufacturing while meeting global regulatory standards for advanced therapies and medicinal products. With its highly skilled and experienced workforce and regulatory agency approved manufacturing capabilities, FUJIFILM Biotechnologies California is shaping the future of medicine through the advanced production of cell therapies. The company leverages the global network and end-to-end CDMO capabilities of the Fujifilm Life Sciences Group to provide solutions that support complex cell therapy development and manufacturing.
About FUJIFILMÂ
FUJIFILM Americas is the regional headquarters for the Americas. It is comprised of 20 group companies across North and Latin America that are engaged in the research, development, manufacture, sale and service of Fujifilm products and services. The company's portfolio represents a broad spectrum of industries including medical and life sciences, electronic materials, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography. For more information, please visit:Â https://www.fujifilm.com/us/en/about/region.
FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of "giving our world more smiles," we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY/USD). For more information, please visit: https://holdings.fujifilm.com/en/. For further details about our commitment to sustainability and Fujifilm's Sustainable Value Plan 2030, click here.
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 those about the manufacturing arrangement with FUJIFILM Biotechnologies California, the availability of manufacturing capacity to support the remainder of BriaCell's ongoing pivotal Phase 3 study, the potential for future commercial-scale manufacturing of Bria-IMT, the continued development and commercialization of Bria-IMT, and the evaluation of Bria-IMT in BriaCell's ongoing pivotal Phase 3 study in advanced metastatic breast cancer, 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.comÂ
Investor Relations Contact:
investors@briacell.com
