BriaCell Announces First Patient Dosed with Bria-OTS™ in Metastatic Breast Cancer Study

Rhea-AI Summary

BriaCell Therapeutics (NASDAQ: BCTX) has initiated dosing in its Phase 1/2 study of Bria-OTS™, a personalized next-generation immunotherapy for metastatic breast cancer. The study will evaluate Bria-OTS™ both as a standalone treatment and in combination with BeiGene's tislelizumab®. This therapy is an enhanced version of Bria-IMT™, which is currently in Phase 3 trials. The clinical trial targets patients with metastatic or locally recurrent breast cancer who have failed at least two prior systemic therapies. The company also plans to evaluate Bria-OTS+™, an advanced version, for prostate and other cancers.

Positive

• Advancement to Phase 1/2 clinical trials with first patient dosed
• Partnership with BeiGene for combination therapy study
• Potential expansion into prostate and other cancer treatments

Negative

• None.

Insights

Medical Research Analyst

This Phase 1/2 clinical trial initiation for Bria-OTS™ represents a significant development in personalized cancer immunotherapy. The study's design, combining monotherapy and checkpoint inhibitor combination approaches, is particularly noteworthy for several reasons:

• It targets a critical unmet need in metastatic breast cancer patients who have progressed after ADC and CPI treatments
• The technology builds upon Bria-IMT™, which is already in Phase 3 trials, suggesting a mature development pipeline
• The planned expansion into prostate and other cancers indicates broader market potential

The collaboration with BeiGene for tislelizumab® adds credibility to the program. However, investors should note that as a Phase 1/2 trial, significant revenue potential remains years away. With a market cap of $21.7M, the company's valuation appears to price in significant risk factors despite the promising technology platform.

• Phase 1/2 dose escalation study to evaluate BriaCell’s personalized next generation immunotherapy treatment in metastatic breast cancer
• Bria-OTS™ to be studied as monotherapy and in combination with BeiGene’s anti-PD-1 antibody

PHILADELPHIA and VANCOUVER, British Columbia, Nov. 21, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) a clinical-stage biotech company that develops novel immunotherapies to transform cancer care, announces that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673) to evaluate the safety and efficacy of Bria-OTS™, BriaCell’s personalized next generation immunotherapy. The study will investigate Bria-OTS™ alone and in combination with immune check point inhibitor tislelizumab^® (manufactured and supplied by BeiGene, Ltd.) for the treatment of metastatic breast cancer. Bria-OTS™ is an enhanced form of Bria-IMT™, currently in pivotal Phase 3 study for metastatic breast cancer.

“Oncologists have been looking for treatments for our metastatic cancer patients who progress after treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs),” stated Sant P. Chawla, MD, FRACP, Head of the Sarcoma Oncology Center in Santa Monica, CA, and Principal Investigator for the Bria-OTS™ study. “We are very impressed by the survival and clinical benefit data we have seen with Bria-IMT™ and are looking forward to helping develop this novel platform with the goal of improving patient outcomes.”

“Dosing the first patient with Bria-OTS™ is a significant milestone for both BriaCell and cancer patients,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “This represents a new chapter in cancer immunotherapy. This groundbreaking technology is a major advancement over prior approaches to cellular immunotherapy.”

“Designed for superior efficacy and synergy with immune checkpoint inhibitors, Bria-OTS™ is a personalized and off-the-shelf cancer therapy,” stated William V. Williams, MD, BriaCell’s President & CEO. “We are delighted that Dr. Chawla and his team of experts at the Sarcoma Oncology Center are supporting BriaCell as we bring our novel immunotherapy platform one step closer to delivering safe and effective treatment options for patients with melanoma, prostate and lung cancers.”

The Phase 1/2 clinical trial will initially evaluate the safety and efficacy of Bria-OTS™ as monotherapy and, later, in combination with tislelizumab^® in advanced breast cancer. Key inclusion criteria include metastatic or locally recurrent breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design will include a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with tislelizumab^®. Additionally, BriaCell plans to evaluate Bria-OTS+™, a more advanced version of the immunotherapy platform, in prostate and other cancers.

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 include: the Phase 1/2 clinical trial initially evaluating the safety and efficacy of Bria-OTS™ as monotherapy and later in combination with tislelizumab^® in advanced breast cancer; statements about the key inclusion criteria for such Phase 1/2 clinical trial; the anticipated study design including a dose escalation monotherapy phase followed by an expansion phase which will include combination therapy with tislelizumab^®; statements about BriaCell continuing to develop the Bria-OTS™ platform with the goal of improving patient outcomes; statements about BriaCell’s plans to evaluate the Bria-OTS™ platform in prostate and other cancers; and statements about the Bria-OTS™ platform representing a major advancement over prior approaches to cellular immunotherapy. Forward-looking statements 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. 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 

Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com

Investor Relations Contact:
CORE IR
investors@briacell.com

FAQ

What is the current phase of BriaCell's (BCTX) Bria-OTS clinical trial?

BriaCell has initiated a Phase 1/2 dose escalation study for Bria-OTS™ in metastatic breast cancer patients.

What cancers will BriaCell's (BCTX) Bria-OTS therapy target?

Initially, Bria-OTS targets metastatic breast cancer, with plans to expand to prostate and other cancers through Bria-OTS+™.

Who is BriaCell (BCTX) partnering with for the Bria-OTS combination therapy?

BriaCell is partnering with BeiGene, which manufactures and supplies tislelizumab®, the anti-PD-1 antibody used in the combination therapy.

What are the patient eligibility criteria for BriaCell's (BCTX) Bria-OTS trial?

Patients must have metastatic or locally recurrent breast cancer and have failed at least two prior attempts of systemic therapy.