BriaCell Therapeutics Presents Clinical Data at the American Association for Cancer Research (AACR) Annual Meeting 2021

Rhea-AI Summary

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) presented clinical trial data on Bria-IMT™ at the AACR Annual Meeting 2021. The results indicated significant disease control in advanced breast cancer patients, especially those with Grade I/II tumors. Key findings include:

• Median overall survival of 12.5 months for Grade I/II tumors vs. 7.2-9.8 months in recent studies.
• 67% disease control rate in Grade I/II patients with a median of 8 prior therapies.
• Prolonged progression-free survival of 8 months associated with a robust immune response.

Positive

• Significant disease control observed in advanced breast cancer patients treated with Bria-IMT™.
• Median overall survival in Grade I/II tumors (12.5 months) exceeds recent benchmarks.
• 67% disease control rate in Grade I/II patients indicates strong therapeutic potential.

Negative

• None.

Clinical and pathological data presented from the clinical trials of Bria-IMT™ alone and in combination with immune checkpoint inhibitors in advanced breast cancer indicates high responding subset with protracted progression-free survival:

• Data suggests a link with cancer grade, disease control, and progression-free-survival in patients treated with Bria-IMT™.
• Highest rate of disease control and longest progression free survival were observed in patients with Grade I/II tumors.
• Median overall survival of 12.5 months in patients with Grade I/II tumors versus 7.2-9.8 months in a recent study of third line breast cancer.
  

BERKELEY, Calif. and VANCOUVER, British Columbia, April 12, 2021 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce the presentation of results from clinical studies with its lead product candidate, Bria-IMT™, summarized in a poster session held at the American Association for Cancer Research (AACR) Annual Meeting 2021, a virtual meeting, held over two weeks (Week 1: April 10-15; Week 2: May 17-21).

The findings indicate disease control in advanced breast cancer patients, including stable disease (SD), partial responses (PR) or complete responses (CR). Disease control was especially noted in patients with Grade I/II (i.e. well or moderately differentiated) tumors or those that matched Bria-IMT™ at 2 or more HLA alleles. Patients with low or undetectable levels of circulating cancer cells were more likely to benefit from therapy.

Patients were treated with the Bria-IMT™ regimen alone (i.e. monotherapy study) or the Bria-IMT™ regimen in combination with immune checkpoint inhibitors, including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), and, more recently, Incyte’s retifanlimab (INCMGA00012, under a corporate collaboration with Incyte Corporation). Dr. Bill Williams, BriaCell’s President & CEO, presented the results of the clinical and pathological analysis. The patient data summarized and discussed belong to previously disclosed patients (i.e., no incremental numbers enrolled).

Details and results on the poster presentation are summarized below:

Poster Title: Predictors of response to a modified whole tumor cell immunotherapy in patients with advanced breast cancer from two phase I/IIa trials

Analysis and Discussion:

• The Bria-IMT™ regimen with or without checkpoint inhibitors is able to induce an effective immune response and disease control in heavily pre-treated advanced breast cancer patients. The patients were all heavily pretreated and failed multiple prior regimens.
• Delayed Type Hypersensitivity (DTH) to Bria-IMT™ analysis identified a group with significantly higher rates of disease control and progression-free survival (8 months) in both monotherapy and combination therapy studies suggesting a robust immune response is predictive of clinical benefit in these patients.
• Highest levels of disease control and PFS was observed in patients who matched Bria-IMT™ at 2 or more HLA alleles in the monotherapy study but not in the combination therapy study supporting our strategy to develop Bria-OTS™, an off-the-shelf personalized immunotherapy for advanced breast cancer.
• Patients with Grade I/II tumors (median of 8 prior therapy regimens) were more likely to respond with disease control (67%) and longer progression free survival. The response was more pronounced in the patients in the combination therapy study suggesting additive or synergistic effects of checkpoint inhibitors when combined with the Bria-IMT™ regimen. Bria-IMT™, with a molecular signature most closely related to Grade I/II tumors, may result in disease control and clinical benefit especially in this subset of patients.

A copy of the poster is posted at the following: https://briacell.com/novel-technology/scientific-publications/.

About BriaCell Therapeutics Corp.

BriaCell is an immuno-oncology focused biotechnology company developing targeted and effective approaches for the management of cancer.

For additional information on BriaCell, please visit: https://briacell.com/.

Forward Looking Statements

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 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 in the section titled “Risk Factors” in the Company’s SEC filings. 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 TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture 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

FAQ

What were the results of the Bria-IMT™ clinical trials presented at AACR 2021?

The trials showed significant disease control in advanced breast cancer patients, especially those with Grade I/II tumors, with a median overall survival of 12.5 months.

How does Bria-IMT™ perform in patients with different tumor grades?

Bria-IMT™ demonstrated a higher disease control rate of 67% in patients with Grade I/II tumors.

What is the significance of the findings related to immune response and progression-free survival?

The findings suggest that a robust immune response is predictive of clinical benefit, with prolonged progression-free survival observed in patients responding to Bria-IMT™.

What is BriaCell's next step following the AACR presentation?

BriaCell aims to further develop Bria-OTS™, an off-the-shelf personalized immunotherapy for advanced breast cancer.