BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS™ in Advanced Metastatic Breast Cancer
Rhea-AI Summary
BriaCell Therapeutics (NASDAQ: BCTX, BCTXW; TSX: BCT), a clinical-stage biotechnology company, has initiated a first-in-human Phase 1/2 study for its immunotherapy, Bria-OTS™, targeting advanced metastatic breast cancer. The study aims to evaluate the safety and efficacy of Bria-OTS™ both as a monotherapy and in combination with the PD-1 inhibitor tislelizumab. This milestone follows the successful completion of Institutional Review Board (IRB) and Clinical Trial Site Agreement (CTA) processes, along with FDA authorization for Investigational New Drug (IND) filings. BriaCell's leadership believes the personalized approach of Bria-OTS™ could lead to more potent and durable responses, potentially improving patients' quality of life and extending survival. The treatment's off-the-shelf nature is expected to provide rapid therapeutic intervention, important for patients with advanced metastatic breast cancer.
Positive
- Initiation of first-in-human Phase 1/2 study for Bria-OTS™.
- Evaluation of Bria-OTS™ both as monotherapy and in combination with PD-1 inhibitor tislelizumab.
- Successful completion of IRB and CTA processes.
- FDA authorization for IND filings.
- Potential for rapid treatment due to off-the-shelf nature of Bria-OTS™.
- Personalized immunotherapy could improve quality of life and add months or years to patient survival.
Negative
- Study is in an early-phase (Phase 1/2), so results and efficacy are not yet proven.
- Potential risks associated with the safety and efficacy of a new treatment in a clinical trial setting.
- High expectations may not be met, affecting stock performance if results are not favorable.
News Market Reaction – BCTX
In the trading session that priced this news, BCTX gained 3.25%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
PHILADELPHIA and VANCOUVER, British Columbia, May 30, 2024 (GLOBE NEWSWIRE) -- 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 initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS™, BriaCell’s personalized off-the-shelf next generation immunotherapy, as monotherapy and in combination with PD-1 inhibitor tislelizumab, in advanced metastatic breast cancer.
“Advancing Bria-OTS™ as our second novel immunotherapy candidate into the clinic is a significant milestone for BriaCell. We believe personalization through our Bria-OTS™ immunotherapy platform will produce more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We are grateful to our scientific and clinical teams for the successful completion of the Institutional Review Board (IRB), Clinical Trial Site Agreement (CTA), and obtaining FDA authorization for the Investigational New Drug (IND) filings, as well as to our investors and collaborators for their support in bringing Bria-OTS™ one step closer to cancer patients.”
Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer stated, “The off-the-shelf nature of our treatment will allow the patients to be treated rapidly – which can be life changing for advanced metastatic breast cancer patients. Additionally, we expect the preferred safety profile of our personalized immunotherapy, Bria-OTS™, to improve the quality of life and add months and even years to the lives of these heavily pretreated patients, a distinctive combination of benefits in late-stage cancer care.”
About Bria-OTS™ Platform
Awarded numerous US and international patents and supported by clinical data of Bria-IMT™, BriaCell’s lead clinical candidate - currently in a pivotal Phase 3 study for advanced metastatic breast cancer (ClinicalTrials.gov NCT06072612), Bria-OTS™ is BriaCell’s personalized off-the-shelf immunotherapy platform, and the basis for BriaCell’s “OTS” strategy. Bria-OTS™ for advanced metastatic breast cancer is the first use of this platform. Similar cell lines are in development for prostate cancer (Bria-PROS+™), lung cancer (Bria-LUNG+™), and melanoma (Bria-MEL+™).
An Investigational New Drug Application (IND) is currently open for the Bria-OTS™ breast cancer therapy also known as, Bria-BRES™ for advanced metastatic breast cancer. Bria-BRES™ will initiate a bucket trial (i.e. a study that investigates multiple product candidates in a single study) with other cancer indications.
Bria-OTS™ received a Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI). More information is available at https://briacell.com/briaots/.
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, including those about BriaCell's personalization through the Bria-OTS™ immunotherapy platform producing more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor; the preferred safety profile of Bria-OTS™ improving the quality of life and increasing the lifespan of heavily pretreated patients; and Bria-BRES™ initiating a bucket trial with other cancer indications, 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
Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
