Preliminary safety and efficacy data is being presented on May 29 at 9:00 a.m. ET from the clinical trials of Bria-IMT™ alone or in combination with immune checkpoint inhibitors in advanced breast cancer:
• Lead candidate, Bria-IMT™, with or without a PD-1 inhibitor, showed no serious side effects and resulted in clinical responses in heavily pre-treated patients with metastatic breast cancer.
• Women 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”.
• Bria-IMT™ in combination with INCMGA00012 (from Incyte Corporation): data from first patient presented.
BERKELEY, Calif., and VANCOUVER, British Columbia, May 29, 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 pleased to present the results of clinical studies with its lead product candidate, Bria-IMT™, summarized in a poster session during the 2020 ASCO Annual Meeting, a virtual event held during the dates of the originally planned in-person Annual Meeting (May 29-June 2, 2020). The ASCO Annual Meeting represents the world’s largest gathering of oncology physicians, biotechnology executives, researchers, and investment analysts to discuss cutting-edge clinical research and therapeutics in oncology.
Dr. Bill Williams, BriaCell’s President & CEO, and Dr. Charles Wiseman, BriaCell’s Scientific Founder and Director, are presenting clinical data in relationship to pathological findings from the Phase I/IIa studies of Bria-IMT™ alone or in combination with checkpoint inhibitors in advanced breast cancer patients. The patient data summarized and discussed belong to previously-disclosed patients (ie – no incremental numbers enrolled).
The abstracts published in advance of the ASCO meeting were made available in the ASCO Meeting Library, and are available in the Journal of Clinical Oncology as at May 26, 2020.
The poster summarized data of the Bria-IMT™ monotherapy study and the ongoing Phase I/IIa clinical study of Bria-IMT™ in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012, in advanced breast cancer.
The details of BriaCell’s ASCO poster are as follows:
Presentation Title: Breast cancer grade and clinical benefit in patients with advanced breast cancer treated with an engineered whole tumor cell-targeted immunotherapy alone or in combination with checkpoint inhibition.
Session Date: Friday, May 29, 2020
• The Bria-IMT™ treatment regimen, with or without a PD-1 inhibitor, showed no serious side effects.
• 23 patients in the studies had “poorly” differentiated tumors, 9 had “moderately” differentiated and one had a “well” differentiated tumor.
• The poster focuses on 10 patients with “moderately” and “well” differentiated tumors. They had been treated with an average of 8 prior treatment regimens including chemotherapy.
o Of the 10 patients, 7 received the Bria-IMT™ regimen alone, 2 received the Bria-IMT™ regimen with a PD-1 inhibitor and 1 received both regimens.
o 71% of the patients treated with the Bria-IMT™ regimen alone, who were also able to develop an immune response, experienced disease control. This included one patient with a partial response.
o All 3 patients treated in combination with a PD-1 inhibitor had disease control (100%).
Following the presentation, a copy of the poster will be posted on https://briacell.com/novel-technology/scientific-publications/.
On another note, BriaCell’s abstract for the American Association for Cancer Research (AACR) meeting is available for viewing through the AACR website. The AACR annual meeting, a virtual event this year, will take place in June 22-24, 2020.
About American Society of Clinical Oncology (ASCO) Conference
Founded in 1964, ASCO is the world’s leading professional organization for physicians, oncology professionals, and research scientists in the field of oncology. ASCO’s mission over the years has been to conquering cancer through research, education, and promotion of the highest quality patient care.
ASCO’s annual meeting represents the world’s largest gathering of oncology physicians, biotechnology executives, researchers, patient advocates, and investment analysts to discuss cutting-edge clinical research and therapeutics in oncology, and to gain insights for improving cancer care.
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.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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.
For further information, please contact:
BriaCell Therapeutics Corp.:
William V. Williams, MD
President & CEO
BriaCell Therapeutics Corp.:
Manager, Corporate Development