• Patient initially identified September 19, 2019 as a Remarkable Responder;
• Patient has continued to experience a highly remarkable reduction in tumors that had metastasized to areas outside of the breasts;
• A metastasized tumor behind the left eye orbital region, which had pushed the eye forward from the skull, has now completely disappeared;
• Prior to BriaCell’s treatment, patient had failed prior regimens with 16 agents (13 chemotherapy and 3 hormonal);
• Patient remains on BriaCell’s treatment.
BERKELEY, Calif., and VANCOUVER, British Columbia, January 13, 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 provide an update on the previously-announced (Link) top responder (“Remarkable Responder”) in the combination study of its lead candidate, Bria-IMT™, with Incyte’s INCMGA00012, a PD-1 inhibitor.
The patient, who had experienced notable tumor shrinkage while on treatment with Bria-IMT™ in combination with the PD-1 inhibitor pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)], has since transitioned to treatment in combination with INCMGA00012. On this combination treatment, the patient has had a subsequent further remarkable reduction in a breast cancer tumor behind the left eye in the left orbital region. This tumor, which had pushed the eye forward from the skull (known as proptosis), has resolved following 3 months of treatment. The tumor had shrunk by 19% during treatment with the Bria-IMT™ regimen in combination with KEYTRUDA®, and has now completely disappeared during treatment in combination INCMGA00012. While not all of the patient’s tumors have resolved, the proptosis and associated eye problem have been resolved.
BriaCell’s “matching hypothesis” has been further strengthened: The Remarkable Responder matched Bria-IMT™ at 2 HLA loci (HLA-C and HLA-DRB3). BriaCell’s immunotherapy treatment appears most effective when the patient’s HLA-type matches the Bria-IMT™ HLA-type as concluded in prior Phase IIa proof-of-concept work.
“The complete regression of a tumor this large and this advanced, in a patient resistant to 16 previous treatment regimens, is unprecedented in my 50 years of clinical practice,” said Dr. Charles Wiseman, BriaCell’s Scientific Founder and Director. “These very important positive clinical observations support BriaCell’s strategy to continue investigating the combination regimen of Bria-IMT™ with checkpoint inhibitors, and may lead to a new treatment option for breast cancer patients suffering advanced, resistant disease.”
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/.
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 which involves 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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