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- Agreement supports potential commercial readiness for Bria-IMT using Uneedle's proprietary microneedle technology for intradermal administration
- Technology is currently used in BriaCell's pivotal Phase 3 study and is designed to support faster, more convenient administration while enhancing the patient and provider experience
- Bria-IMT is currently being evaluated in BriaCell's ongoing pivotal Phase 3 study in advanced 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, has entered into a Memorandum of Understanding ("MoU"), with Uneedle, a microneedle based drug-delivery device company in the Netherlands, to support the continued use and commercial readiness of Uneedle's proprietary microneedle technology for intradermal administration of BriaCell's lead Phase 3 clinical candidate, Bria-IMT, for the treatment of metastatic breast cancer.
The MoU reflects the continued commitment of BriaCell and Uneedle to collaborate on the potential regulatory and commercial development of BriaCell's cell-based immunotherapy Bria-IMT. The non-binding MoU is intended to establish a plan that details scaling of Uneedle's microneedle devices for use in commercial quantities. All activities and projections described herein are contingent upon successful regulatory approval of BriaCell's lead Phase 3 clinical candidate, Bria-IMT, in the relevant jurisdictions.
Bria-IMT is currently being evaluated in BriaCell's ongoing pivotal Phase 3 study in advanced metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612). Uneedle's microneedle technology is being used in this pivotal study to intradermally administer Bria-IMT.
"Efficient and reliable drug administration is integral to treating cancer patients," said William V. Williams, MD, President and Chief Executive Officer of BriaCell. "Uneedle's microneedle technology is already being used in our pivotal Phase 3 study, and we believe this approach may support faster, more convenient administration and a more patient-friendly treatment experience."
"Precision and consistency in intradermal drug delivery are important attributes for therapies administered into the skin," said Jeroen Wissink, Chief Executive Officer of Uneedle. "We are excited to work with BriaCell to support the use of our proprietary microneedle technology for Bria-IMT and to help advance delivery readiness ahead of potential commercialization."
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 Uneedle
Founded in 2008, and based in Enschede, The Netherlands, Uneedle is a drug-delivery device company specializing in design and GMP compliant manufacturing of proprietary silicon microneedle platforms for precise intradermal and suprachoroidal drug delivery. More information is available at https://www.uneedle.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 those about BriaCell's collaboration with Uneedle, the potential regulatory and commercial development of Bria-IMT, the potential commercial readiness and scaling of Uneedle's microneedle technology for administration of Bria-IMT, the anticipated benefits of such technology, and the ongoing Phase 3 evaluation of Bria-IMT 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.com
Investor Relations Contact:
investors@briacell.com
