Clinical and pathological findings presented from the clinical trials of Bria-IMT™ alone or in combination with immune checkpoint inhibitors in advanced breast cancer:
• Median overall survival of 12.5 months in patients with moderately-well differentiated tumors despite an average of 7 failed prior therapy regimens (versus 7.2-9.8 months of others).
• Prolonged survival rates and highest tumor reductions were observed in specific patients identifiable through two different bio-marker techniques: tumor type and HLA types.
BERKELEY, Calif. and VANCOUVER, British Columbia, January 26, 2021 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF), 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 January 25-27 during the 2021 Keystone Symposium, “Emerging Cell Therapies: Realizing the Vision of NextGen Cell Therapeutics,” a virtual scientific conference.
Overall, the data suggests a potentially significant survival benefit for the patients treated with the Bria-IMT™ regimen alone or in combination with checkpoint inhibitors, especially in those with moderately or well differentiated tumors or those who match Bria-IMT™ at 2 HLA alleles. We hypothesize that Bria-IMT™, with a molecular signature most closely related to moderately or well differentiated tumors, may result in disease control especially in patients with moderately-well differentiated tumors. The patient data summarized and discussed belong to previously-disclosed patients (i.e., no incremental numbers enrolled).
Dr. Bill Williams, BriaCell’s President & CEO, presented the clinical and pathological data of Bria-IMT™ monotherapy (i.e., the Bria-IMT™ regimen alone) and Bria-IMT™ in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012 (under a corporate collaboration with Incyte Corporation), in advanced breast cancer.
Details and results on the poster presentation are summarized below:
Poster Title: Personalized off-the-shelf whole cell immunotherapy for cancer
Monotherapy Study – 27 patients: The patients were heavily pre-treated (median of 5 prior therapy regimens). Disease control including stable disease (SD), partial responses (PR) or complete responses (CR) was seen in 8 patients (30%) suggesting clinical benefit. Importantly, disease control was more frequent in patients who had 2 or more HLA matches with Bria-IMT™ (67%) or had moderately or well differentiated tumors (63%) suggesting the potential importance of these factors in designing the next generation of personalized immunotherapies.
Combination Study – 12 patients (Bria-IMT™ regimen with checkpoint inhibitors): The patients were heavily pre-treated (median of 6 prior therapy regimens). Disease control was seen in 4 patients (33%). Importantly, patients with moderately or well differentiated tumors were more likely to achieve disease control (3/4, 75%) suggesting clinical benefit in this subset of patients. Furthermore, the data suggests the potential additive or synergistic effects of check point inhibitors when combined with the Bria-IMT™ regimen.
Patients with moderately or well differentiated tumors: The patients with moderately or well differentiated tumors (monotherapy and combination therapy studies combined) were heavily pre-treated (median of 8 prior therapy regimens). Disease control was seen in 7 of 11 patients (64%) suggesting clinical benefit in this subset of patients. This included 2 of 5 patients with objective responses, both of whom had 2 or more HLA matches with Bria-IMT™. Overall survival (OS), collected in 6 patients, was 12.5 months suggesting clinical benefit. In comparison, an OS of 7.2-9.8 months was reported in similar patients in the third line setting (Kazmi S, et al., Breast Cancer Res Treat. 2020).
Capitalizing on these findings, BriaCell has engineered cell lines to express specific HLA alleles allowing a single HLA match with ~99% and a double HLA match with ~90% of the population. These cell lines will provide a personalized approach to cancer immunotherapy that is pre-manufactured rather than prepared individually per patient, eliminating the time and complex manufacturing logistics of other personalized immunotherapies.
A copy of the poster will be posted at the following: https://briacell.com/novel-technology/scientific-publications/.
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/.
Cautionary Note Regarding Forward-Looking Information
Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation (also known as “forward-looking statements”) which are subject to known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.
These forward-looking statements include, but are not limited to, BriaCell’s plans, objectives, expectations and intentions. Such forward-looking statements reflect BriaCell’s current beliefs and are based on information currently available to management. Although the forward-looking statements contained in this news release are based upon what BriaCell believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements.
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For further information, please contact:
BriaCell Therapeutics Corp.:
William V. Williams, MD
President & CEO
BriaCell Therapeutics Corp.:
Manager, Corporate Development