Preliminary safety and efficacy data is being presented today from the clinical trials of Bria-IMT™ alone or in combination with immune checkpoint (PD-1) inhibitors in advanced breast cancer patients.
• Clinical responses and disease control—without serious side effects—in heavily pre-treated patients with metastatic breast cancer seen with lead candidate, Bria-IMT™, with or without a PD-1 inhibitor.
• Patients with “moderately” or “well” differentiated tumors showed a higher rate of disease control and clinical benefit than those with “poorly” differentiated tumors.
• Combination of Bria-IMT™ with pembrolizumab (KEYTRUDA®; by Merck & Co., Inc.) showed disease control in 3 of 3 (100%) patients with “moderately” differentiated tumors even in the absence of “HLA Matching”.
BERKELEY, Calif., and VANCOUVER, British Columbia, June 22, 2020 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, is announcing the results of clinical studies with its lead product candidate, Bria-IMT™, summarized in a poster session during AACR Annual Meeting 2020, Virtual Meeting II, a virtual event held June 22-24, 2020.
The poster describes clinical and pharmacodynamic responses to Bria-IMT™ regimens in patients with advanced breast cancer from two phase I/IIa trials, one with 23 evaluable patients treated with Bria-IMT™ as monotherapy and the other with 11 evaluable patients treated with Bria-IMT™ in combination with pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.). In essence, the poster demonstrates that patients with tumor regression (i.e., a decrease in the size of a tumor) tended to have certain biologic characteristics, including well or moderately differentiated tumors. The patient data summarized and discussed belong to previously-disclosed patients (i.e., no incremental numbers enrolled).
The abstracts published in advance of the AACR meeting were made available for viewing through the AACR website. The poster is posted on https://briacell.com/novel-technology/scientific-publications/.
The details of BriaCell’s AACR poster are as follows:
Presentation Title: Clinical and pharmacodynamic responses to a modified whole tumor cell immunotherapy in patients with advanced breast cancer from two phase I/IIa trials
Session Date: Monday, June 22, 2020
Session Time: 9am ET
• The patients were heavily pre-treated having failed an average of 5 prior regimens.
• Of 23 patients studied, 1 had “well”, and 5 had “moderately” differentiated tumors with the rest poorly differentiated.
• One patient in the monotherapy study with a “poorly” differentiated tumor showed tumor regression, whereas 2 patients with “well” or “moderately” differentiated tumors had tumor regressions.
• The responders have a higher tendency to develop T cell proliferative responses per se compared to non responders.
• The patients were heavily pre-treated having failed an average of 4 prior regimens.
• Of 11 patients in the study with KEYTRUDA®, 3 had “moderately” differentiated tumors.
• Tumor regression was observed in 2 patients. Both patients had “moderately” differentiated tumors, similar to the tumor from which Bria-IMT™ was derived.
• Patients with “well” or “moderately” differentiated tumors were analyzed separately. This included 6 patients from the monotherapy study (5 able to develop an immune response) and 3 from the combination therapy study (all able to develop an immune response). One patient started her treatment on monotherapy study and continued on the combination therapy study.
• Patients had multiple prior treatments with median of 7 prior treatment regimens.
• Patients with “well” or “moderately” differentiated tumors were more likely to show disease control (86% response rate in immune responders).
In conclusion, the data indicates that the Bria-IMT™ regimen with or without KEYTRUDA® appears to be able to induce an effective immune response and tumor regression in advanced breast cancer patients. Patients with “well” or “moderately” differentiated tumors were more likely to respond with tumor regression and disease control. A more robust immune response appeared to have occurred in patients who responded to treatment with tumor regression compared to those who did not.
The AACR was founded in Washington, D.C., May 7, 1907, by a group of 11 physicians and scientists intending “to further the investigation and spread the knowledge of cancer.” To prevent and cure cancer using research, education, communication, collaboration, funding and advocacy has been the mission of AACR. With its programs and services, AACR advances research in cancer and related biomedical science by facilitating exchange of knowledge and innovations among scientists and clinicians dedicated to the fight against cancer, providing education and training in oncology treatment and advancing cancer etiology, prevention, early detection, diagnosis and treatment worldwide.
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/.
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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.
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For further information, please contact:
BriaCell Therapeutics Corp.:
William V. Williams, MD
President & CEO
BriaCell Therapeutics Corp.:
Manager, Corporate Development