BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS™ in Advanced Metastatic Breast Cancer
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.
- 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.
- 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.
Insights
BriaCell's initiation of the first-in-human study for Bria-OTS™ in advanced metastatic breast cancer represents a significant milestone in cancer treatment. The Phase 1/2 trial is important because it aims to evaluate both the safety and efficacy of this new immunotherapy, which is essential for gaining regulatory approval and wider clinical use.
The study's focus on personalized off-the-shelf immunotherapy is particularly innovative, as it could offer rapid treatment options for patients. Traditional immunotherapies often require complex, time-consuming processes to develop patient-specific treatments. Bria-OTS™ aims to streamline this by having pre-developed options that can be readily administered. This could be a game-changer for patients who need immediate care.
The combination with the PD-1 inhibitor tislelizumab also adds an interesting dimension. PD-1 inhibitors are known to enhance the immune system's ability to fight cancer and combining this with Bria-OTS™ could potentially result in synergistic effects, offering better outcomes than either treatment alone. This approach aligns with current trends in oncology, where combination therapies are increasingly seen as the future of cancer treatment.
However, it's important to note that this is an early-stage trial. While the potential benefits are substantial, there are inherent risks associated with any new treatment. Investors should watch for initial safety data and early efficacy signals before making any informed decisions. The success of this trial could significantly impact BriaCell's stock and market position.
The initiation of this trial is noteworthy for its focus on advanced metastatic breast cancer, a condition with limited treatment options and generally poor prognosis. The use of personalized immunotherapy, especially one that is off-the-shelf, could revolutionize the current treatment landscape. The rapid treatment capability could be critical for patients who do not have the luxury of time for custom-developed therapies.
Moreover, the expected preferred safety profile of Bria-OTS™ is a significant advantage. Many existing treatments for late-stage cancer come with severe side effects, which can drastically affect the patient's quality of life. If Bria-OTS™ can deliver on its promise of better safety and efficacy, it could become a preferred option for oncologists.
The collaboration with the PD-1 inhibitor tislelizumab also suggests a forward-thinking approach. PD-1 inhibitors have already shown great promise in various cancers and their combination with a personalized immunotherapy could yield better patient outcomes. However, the effectiveness and safety of such a combination will need to be closely monitored during the trial.
From a clinical perspective, this trial is a promising step forward. However, it's important to manage expectations as many early-stage trials face hurdles. Initial data will be important in determining the future potential of Bria-OTS™ in clinical practice.
From a financial perspective, BriaCell's initiation of this clinical trial is a positive development for the company. Clinical trials are expensive and resource-intensive, but their successful completion can significantly enhance a company's valuation and attract more investors. The fact that BriaCell has obtained FDA authorization and completed necessary regulatory steps is a good indicator of the company's capability to navigate complex medical and regulatory landscapes.
Investors should note that while the news is promising, the company is still in the early stages of clinical development. Successful early-phase trials can lead to increased stock volatility, influenced by trial results, announcements and regulatory updates. The market often reacts strongly to initial data releases, so keeping an eye on the study's progress and interim results will be crucial.
Additionally, the combination therapy involving Bria-OTS™ and tislelizumab could open up lucrative partnerships or licensing opportunities if initial results are favorable. This could add significant revenue streams and enhance shareholder value. However, given the inherent risks and high costs associated with clinical trials, investors should remain cautious and consider the long-term horizon.
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
FAQ
What is Bria-OTS™?
What is the significance of the Bria-OTS™ Phase 1/2 study?
What makes Bria-OTS™ different from other treatments for metastatic breast cancer?
When did BriaCell initiate the first-in-human study for Bria-OTS™?
What are the potential benefits of Bria-OTS™ for patients with advanced metastatic breast cancer?
What stock symbol does BriaCell Therapeutics trade under?
