• BriaCell has identified a patient population Biomarker with high rate of clinical benefit from the treatments based on ‘Breast Cancer Grade’;
• Breast Cancer Grade correlates with response in both studies of monotherapy (Bria-IMT™ alone), and combination study of Bria-IMT™ with KEYTRUDA®;
• New predicative Biomarker capability is complimentary to BriaCell’s HLA-matching hypothesis.
BERKELEY, Calif., and VANCOUVER, British Columbia, January 9, 2020 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, is pleased to announce it has identified a new group of patients with high levels of clinical benefit in response to its novel immunotherapy, and its combinations.
Breast cancer is subdivided into 3 categories based on its appearance under the microscope: Grade 1 (well differentiated), Grade II (moderately differentiated) and Grade III (poorly differentiated). The Bria-IMT™ cell line was derived from a Grade II tumor biopsy. Upon reanalysis of our clinical data, we learned of correlative patterns of tumor response in Grade I/II breast cancer patient populations. In our view, this seems logical because Bria-IMT™ is derived from a Grade II (moderately differentiated) breast cancer tumor. Importantly, approximately 40% of recurrent breast cancers are Grade I/II.
Monotherapy: The clinical benefit rate in our monotherapy studies for Grade I/II patients with immune responses was 5/7 (71%) despite the fact that these patients were very heavily pre-treated with a median of 7 prior regimens (such as chemotherapy).
Combination study of Bria-IMT™ with KEYTRUDA®: All 3 patients with Grade I/II tumors had clinical benefit (100%). All of these patients had been very heavily pre-treated with 14-15 prior regimens.
Further analysis of our patients with Grade I/II tumors shows that patients with greatest tumor reductions within the Grade I/II subset also had double HLA matches with Bria-IMT™ in both monotherapy and combination study groups. Based on our new findings, we believe we are able to identify a sizeable patient population who will derive significant clinical benefit from treatment with Bria-IMT™, adding further biomarker capability incremental to our HLA-matching hypothesis.
“We believe that we have identified an important and sizeable subgroup of patients who will benefit from our novel immunotherapy treatments. We plan to further validate these findings in subsequent patients, strengthening yet another responder biomarker technique,” stated Dr. Williams, BriaCell’s President and CEO.
BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.
BriaCell is conducting a Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with immune checkpoint inhibitors such as the Incyte drugs INCMGA00012 (an anti-PD-1 antibody similar to pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)]) and epacadostat, an orally bioavailable small-molecule inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1). The combination study is listed in ClinicalTrials.gov as NCT03328026.
BriaCell currently has a non-exclusive clinical trial collaboration with Incyte Corporation to evaluate the effects of combinations of novel clinical candidates. Under the agreement, Incyte and BriaCell will be evaluating novel combinations of compounds from Incyte’s development portfolio with BriaCell’s drug candidates in advanced breast cancer patients.
BriaCell is also developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS™, which is expected to cover over 99 percent of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense and complex manufacturing logistics associated with other personalized immunotherapies.
For additional information on BriaCell, please visit: https://briacell.com/.
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Manager, Corporate Development