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BriaCell Announces Clinical Supply Agreement with BeiGene for Bria-OTS™ First in Human Study

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BriaCell Therapeutics has announced a clinical supply agreement with BeiGene to assess the safety and efficacy of BriaCell’s Bria-OTS™ immunotherapy in combination with BeiGene's anti-PD-1 antibody, tislelizumab, for treating advanced, heavily pretreated metastatic breast cancer. This Phase 1/2 trial will initially focus on Bria-OTS™ alone in breast cancer, expanding to a combination therapy with tislelizumab. BriaCell aims to extend this therapy to prostate and other cancers. The Bria-OTS™ platform builds on Bria-IMT™, which has shown benefits in patients with CNS metastases and resistance to checkpoint inhibitors and ADCs.

Positive
  • BriaCell Therapeutics announces a clinical supply agreement with BeiGene.
  • Partnership to evaluate Bria-OTS™ with BeiGene’s tislelizumab in advanced metastatic breast cancer.
  • Phase 1/2 trial will test safety and efficacy of Bria-OTS™ alone and in combination with tislelizumab.
  • Bria-OTS™ is a next-gen immunotherapy with enhanced potency.
  • Potential expansion of Bria-OTS™ therapy to prostate and other cancers.
  • Bria-IMT™ has shown clinical benefits in Phase 2 trials, including survival benefits in CNS metastases.
Negative
  • The trial will initially be access, possibly restricting broader insights and application.
  • Focus on heavily pretreated patients may limit generalizability of results.

Insights

The clinical supply agreement between BriaCell and BeiGene is significant for its potential impact on advanced metastatic breast cancer treatment. Bria-OTS™ aims to build on Bria-IMT™'s success, which already showed clinical benefits in difficult cases, including those with central nervous system metastases. Combining Bria-OTS™ with BeiGene's anti-PD-1 antibody tislelizumab could offer new hope for patients who have exhausted other treatment options.

This combination therapy is particularly noteworthy because anti-PD-1 antibodies work by helping the immune system recognize and attack cancer cells. Tislelizumab, already used in other cancer treatments, could enhance the efficacy of Bria-OTS™, potentially leading to improved survival rates and quality of life for patients. However, it's essential to remain cautiously optimistic; clinical trials will reveal if this combination really provides the anticipated benefits.

For retail investors, this agreement signals BriaCell’s commitment to innovation and its potential to be a strong player in the oncology market. Short-term impacts may include increased visibility and investor interest, but the long-term success will depend on trial results and subsequent regulatory approvals.

From a financial perspective, this agreement positions BriaCell for substantial investor interest and potential future revenue streams. Collaborations with established biopharmaceutical companies like BeiGene can serve as strong validation of BriaCell's technology and strategic direction. If the trials are successful, it could pave the way for new funding opportunities and partnerships, bolstering the company's balance sheet.

However, there are risks to consider. Clinical trials are costly and time-consuming and a negative outcome could dampen investor enthusiasm and impact stock prices. The financial health of BriaCell will be closely tied to its ability to successfully navigate these trials and bring products to market.

Investors should monitor upcoming trial results and watch for any additional strategic partnerships or funding announcements that could further influence the company's financial stability and growth prospects.

From an oncology standpoint, the combination of Bria-OTS™ with tislelizumab is a promising development. Bria-OTS™ is an off-the-shelf immunotherapy, meaning it is readily available compared to personalized treatments, which can be time-consuming to develop. The previous success of Bria-IMT™ in patients resistant to checkpoint inhibitors is encouraging and the addition of tislelizumab could potentially enhance immune system responses against cancer cells.

The trial's design to first assess Bria-OTS™ alone before introducing the combination therapy is methodologically sound. This phased approach ensures that any observed benefits or side effects can be accurately attributed, improving the robustness of the data collected.

For patients with advanced metastatic breast cancer, especially those heavily pretreated with other therapies, this new approach could offer a much-needed therapeutic alternative. Investors should keep an eye on early trial results, as positive outcomes could significantly impact the oncology treatment landscape and BriaCell's market position.

  • Study to evaluate the effects of Bria-OTS™ in combination with anti-PD-1 antibody tislelizumab, in advanced, late stage, heavily pretreated metastatic breast cancer.

PHILADELPHIA and VANCOUVER, British Columbia, May 28, 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 a clinical supply agreement with BeiGene, Ltd. (NASDAQ: BGNE) (“BeiGene”) to evaluate the safety and efficacy of Bria-OTS™, BriaCell’s next generation immunotherapy, in combination with BeiGene's anti-PD-1 antibody, tislelizumab, for the treatment of advanced heavily pretreated metastatic breast cancer.

“We are extremely excited about partnering with BeiGene on this novel immunotherapy approach with planned expansion to prostate and other cancers,” stated Dr. William V. Williams, BriaCell’s President & CEO. “This agreement marks another positive milestone for BriaCell in our commitment to transform cancer care.”

“The Bria-OTS™ platform capitalizes on our success with Bria-IMT™, which has shown clinical benefit after check point inhibitors (CPIs) resistance,” stated Dr. Del Priore, BriaCell’s Chief Medical Officer. “In our randomized Phase 2 and other trials of Bria-IMT™, BriaCell immunotherapy has shown survival and clinical benefit in patients with central nervous system (CNS) metastases and after progression on antibody drug conjugates (ADCs). The Bria-OTS™ platform is the next generation off-the-shelf therapy with enhanced potency. There is rationale to predict that combining Bria-OTS™ with tislelizumab may impart additional benefit in this refractory patient population.”

The limited access Phase 1/2 clinical trial will initially evaluate the safety and efficacy of Bria-OTS™ alone in breast cancer and later in combination with tislelizumab. BriaCell also plans to evaluate Bria-OTS™ 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 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 combining Bria-OTS™ with tislelizumab resulting in additional benefits in the refractory patient population; BriaCell's Phase 1/2 clinical trial in advanced breast cancer initially evaluating the safety and efficacy of Bria-OTS™ alone and later in combination with tislelizumab; and BriaCell evaluating Bria-OTS™ in prostate and other cancers, 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 BriaCell Therapeutics' new clinical supply agreement about?

BriaCell Therapeutics has entered into a clinical supply agreement with BeiGene to evaluate the safety and efficacy of Bria-OTS™ in combination with tislelizumab for treating metastatic breast cancer.

What is the focus of BriaCell's Phase 1/2 trial?

The Phase 1/2 trial will initially focus on the safety and efficacy of Bria-OTS™ for advanced breast cancer, expanding later to include combination therapy with tislelizumab.

What are the potential applications of Bria-OTS™?

Besides breast cancer, BriaCell plans to extend Bria-OTS™ immunotherapy to prostate and other cancers.

What are the benefits of Bria-IMT™ immunotherapy?

Bria-IMT™ has shown clinical and survival benefits in patients with CNS metastases and those resistant to checkpoint inhibitors and antibody drug conjugates.

Which company is partnering with BriaCell for the new clinical trial?

BeiGene is partnering with BriaCell to evaluate Bria-OTS™ in combination with their anti-PD-1 antibody, tislelizumab.

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