Preliminary safety and efficacy data are being presented today from the clinical trials of Bria-IMT™ 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™, in combination with pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), a PD-1 inhibitor.
• Higher levels of immune system activation were directly related to higher incidences of tumor reduction and higher rates of disease control and clinical benefit in patients with advanced breast cancer.
BERKELEY, Calif., and VANCOUVER, British Columbia, August 17, 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 the SSO 2020 International Conference on Surgical Cancer Care™, a virtual event held in the evenings of August 17-18, 2020. The patient data summarized and discussed belong to previously-disclosed patients (i.e., no incremental numbers enrolled).
The poster describes clinical and pharmacodynamic responses to Bria-IMT™ in combination with pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), a PD-1 inhibitor, from a phase I/IIa trial in 11 evaluable advanced breast cancer patients. Our preliminary data showed that in these very heavily pre-treated patients, robust immune activity was associated with more pronounced tumor regression (i.e., a decrease in the size of a tumor), and clinical benefit – including progression free survival rates – in the advanced breast cancer patients who were treated with Bria-IMT™ in combination with KEYTRUDA®.
The poster is posted on https://briacell.com/novel-technology/scientific-publications/.
The details of BriaCell’s SSO 2020 poster are as follows:
Presentation Title: Results of a Phase I/IIa Trial of Combination Whole-Cell Targeted Immunotherapy Vaccine and Checkpoint Inhibitor in Treatment of Metastatic/Recurrent Breast Cancer
Session Dates: August 17-18
Session Time: 6pm ET
• The patients were heavily pre-treated having failed an average of 9 prior treatment agents received.
• Of 11 patients in the study with KEYTRUDA®, a pronounced tumor regression was observed in 2 patients.
• No serious side effects were observed in the patients who were treated with the combination.
• Immune system activation was strongly correlated with clinical benefits in the patients who were treated with the combination.
• The median of progression-free survival was 183 days, suggesting clinical benefit of the treatment in the patients.
In conclusion, no serious side effect was observed in the 11 evaluable patients as a result of the treatment with the Bria-IMT™ regimen with KEYTRUDA®. Additionally, our preliminary data showed that the treatment regimen was able to activate the immune system and induce potential anti-tumor immunity in advanced breast cancer patients. Importantly, a robust immune response appeared to be associated with clinical benefit and more pronounced tumor regression in the patients, suggesting clinical efficacy of the combination regimen in this heavily pre-treated patient population. We have further studied the data of these patients and have identified the patient population that may benefit the most from this treatment regimen. We presented the data recently at the AACR annual meeting.
About Cancer Insight
Founded in 2014, Cancer Insight, LLC, is a Texas-based clinical research organization (CRO) dedicated to discovering, developing and testing emerging biotechnologies specializing in cancer immunotherapy. Cancer Insight offers a vertical range of CRO services from trial design to final execution, with a foundation grounded on decades of academic research and clinical trial experience.
About the SSO 2020 International Conference on Surgical Cancer Care™
Over the years, the SSO 2020 International Conference on Surgical Cancer Care™ has become a meeting venue for practitioners around the world to discuss and offer expertise on a range of cancer related topics. This year, the SSO 2020 International Conference on Surgical Cancer Care™ will take place as a virtual event the evenings of August 17th and 18th. The 2020 conference sessions are comprehensive in the range of topics and the depth of expertise delivered. Management of Breast Cancer in Women Age 70+ will be a focused conference section.
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