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BriaCell Reports 71% Central Nervous System Response Rate in Advanced Breast Cancer Patients

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BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) reports 71% intracranial objective response rate (iORR) in advanced breast cancer patients with CNS metastases treated with Bria-IMT™ regimen, demonstrating clinical efficacy and potential market approval.
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The reported 71% intracranial objective response rate (iORR) with Bria-IMT™, particularly in the context of central nervous system (CNS) metastases from breast cancer, is a significant clinical finding. CNS metastases are known for their poor prognosis and limited treatment options, which makes this high response rate noteworthy. The ability to achieve tumor reduction in a population of heavily pretreated patients, including those with diverse breast cancer subtypes, could signal a meaningful advance in oncology. The retrospective analysis suggests that Bria-IMT™ could potentially fill a gap in current treatment regimens, where antibody-drug conjugates and other therapies may fail.

From a clinical perspective, the addition of a pre-planned subgroup analysis to the Phase 3 study is prudent, as it may help to further validate the efficacy of Bria-IMT™ for this specific patient subset. The data could be instrumental in expanding the use of Bria-IMT™, pending market approval and potentially improve outcomes for patients with limited therapeutic options.

The efficacy of Bria-IMT™ in managing CNS metastases is underlined by the reported iORR, which is a quantitative measure of tumor response. The response rate, especially in a small sample size of seven patients, is an early indicator but must be interpreted with caution. The clinical benefit observed in this retrospective analysis is promising but requires validation in a larger, prospective clinical trial. It is also critical to understand the safety profile of the regimen, as CNS treatments can have significant adverse effects.

Furthermore, the market potential for Bria-IMT™ could be substantial if the Phase 3 trial confirms these preliminary findings. The ability to address CNS metastases can differentiate Bria-IMT™ from other breast cancer treatments and could be a key driver for its adoption. The pre-planned subgroup analysis could strengthen the case for regulatory approval and market access, particularly for a therapy that addresses such a challenging aspect of cancer treatment.

The announcement regarding Bria-IMT™'s efficacy in treating CNS metastases in breast cancer patients has potential market implications. CNS metastases represent a significant unmet medical need and a therapy with a high iORR could capture a niche but critical segment of the oncology market. The treatment's success in a heavily pretreated patient population may also allow BriaCell to position Bria-IMT™ as a last-line therapy, potentially leading to premium pricing.

Investors and stakeholders should monitor the progression of the pivotal Phase 3 trial closely, as positive results could lead to increased investor confidence and a positive impact on BriaCell's stock valuation. The decision to include a subgroup analysis for patients with CNS metastases is strategic, as it may expedite market approval for this indication. However, the long-term market impact will depend on the final trial results, regulatory approvals and the ability of BriaCell to effectively commercialize the treatment.

  • 71% intracranial objective response rate (iORR) in BriaCell patients with Central Nervous System (CNS) metastases support clinical efficacy of Bria-IMT™, alone and in combination with an immune checkpoint inhibitor (CPI)
  • Tumor reductions observed in heavily pretreated patients highlight potential clinical benefit of Bria-IMT™ in managing CNS metastases

PHILADELPHIA and VANCOUVER, British Columbia, Dec. 28, 2023 (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, is pleased to report marked 71% intracranial objective response rate (iORR) in advanced breast cancer patients suffering from central nervous system (CNS) metastases and treated with BriaCell’s Bria-IMT™ regimen. iORR is defined as the percentage of patients who achieve either a complete response (complete disappearance) or partial response (volume reduction of 30% or more) in intracranial tumors.

Breast cancer metastasis (spread of the cancer) to the CNS presents a significant clinical challenge, often leading to poor prognosis and early death. BriaCell has recently conducted a retrospective analysis in breast cancer patients with CNS metastases enrolled across both its Bria-IMT™ monotherapy and combination therapy with CPI studies and found remarkable clinical responses.

“We have accumulated positive clinical responses in five patients with intracranial metastases, which generally are extremely difficult to treat, and have a very poor prognosis. This antitumor activity furthers our excitement in our ongoing Phase 3 pivotal trial studying the Bria-IMT™ regimen in advanced breast cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO.

“The CNS tumor reductions demonstrated in five of seven advanced breast cancer patients are particularly compelling given the history of unsuccessful treatment of CNS metastases in this patient population,” stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer.

BriaCell Clinical Data in Advanced Metastatic Breast Cancer Patients with CNS Metastases
The Bria-IMT™ Regimen (Alone or Combined with a CPI)

  • CNS lesions improved in 71% of patients (5 of 7), supporting clinical efficacy of the Bria-IMT™ regimen
  • Findings provide evidence for the efficacy of the Bria-IMT™ regimen, both alone and in combination with CPI, in CNS metastases patients
  • Heavily pretreated metastatic breast cancer patients had failed multiple prior treatments including one patient who had failed treatments with 2 antibody-drug conjugates
  • Regression of CNS metastatic tumors was observed across all breast cancer subtypes in heavily pretreated patients highlighting the potential of the Bria-IMT™ regimen in managing CNS metastases

BriaCell is adding a pre-planned subgroup analysis of patients with CNS metastases to its pivotal Phase 3 study in advanced metastatic breast cancer patients. This could provide an additional indication for market approval of Bria-IMT™.

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 presented in today’s press release, 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.sedar.com 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
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com

Investor Relations Contact:
CORE IR
investors@briacell.com


BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT)

The reported iORR is 71%.

The Bria-IMT™ regimen is a novel immunotherapy developed by BriaCell Therapeutics Corp. aimed at managing CNS metastases in advanced breast cancer patients.

The clinical responses demonstrate the potential clinical benefit of the Bria-IMT™ regimen in treating CNS metastases, which are difficult to treat and have a poor prognosis.

BriaCell is adding a pre-planned subgroup analysis of patients with CNS metastases to its pivotal Phase 3 study in advanced metastatic breast cancer patients, potentially providing an additional indication for market approval of Bria-IMT™.
BriaCell Therapeutics Corp

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About BCTX

briacell therapeutics corp immunotherapy approaches to cancer management briacell is a los angeles headquartered biotechnology company focused on immunotherapy treatments for cancer management. to date, the company has been successful in developing its patented "briavax" vaccine and implementing two compelling fda phase-i studies with late-stage breast cancer patients, demonstrating unique and unprecedented results. briacell is focused on aggressively moving towards launching its next clinical trial, a phase-i/ii study, in order to apply its vaccine to a larger number of breast cancer patients and effectively progress its technology along the value chain. while the current corporate focus is breast cancer, the company has an eye towards potentially applying its vaccine technology to certain other cancer types as well.