BriaCell Therapeutics’ (TSXV:BCT; OTCQB:BCTXF) clinical findings were published at the 2019 American Society of Clinical Oncology (ASCO) annual meeting proceedings, a supplement to the Journal of Clinical Oncology.
ASCO’s annual meeting, which runs through June 4, is the world’s largest oncology gathering.
Clinical data of 23 advanced breast cancer patients dosed with Bria-IMT in a completed Phase 1/2a clinical study showed that Bria-IMT immunotherapy treatment was safe and well tolerated, and tumor regression was reported in several advanced breast cancer patients who failed a number of previous treatments.
The top-responder patients matched Bria-IMT at specific HLA (human leukocyte antigen) types, suggesting a unique mechanism of action for Bria-IMT, which sets it apart from other immunotherapy products.
The findings have been the basis for the development of Bria-OTS, the company’s off-the-shelf personalized immunotherapy for advanced breast cancer, and BriaDX, a companion diagnostic identification test. Bria-OTS is expected to receive FDA approval to begin clinical testing in late 2019.
“Our clinical findings published at the 2019 ASCO meeting have provided new insights into the potential of Bria-IMT immunotherapy to offer clinical benefits to advanced breast cancer patients, both as monotherapy, and in combination with other drugs,” Dr. Bill Williams, BriaCell’s president and CEO, said in a statement.
“We are excited with the potential clinical benefits of Bria-IMT in combination with KEYTRUDA and with INCMGA00012 and epacadostat (experimental drugs manufactured by Incyte) and look forward to sharing additional data in the second half of 2019,” he added.
In addition, BriaCell participated in a prospective 12-month multi-institutional pilot study of cancer-associated macrophage-like cells (CAMLs) in the blood of the patients with advanced breast cancer. The patient’s blood samples were analyzed to determine the value of CAMLs as an independent indicator of survival in these patients.
The data indicated that monitoring CAML changes over the initial period of treatment accurately predicted the responsiveness of patients to experimental therapy.
Dr. Markus Lacher, BriaCell’s head of R&D, said these important findings should help BriaCell better monitor and evaluate the anti-tumor response to Bria-IMT in advanced breast cancer patients, and modify the course of treatment if necessary.
“We have seen very intriguing changes in CAMLs in our patients treated with Bria-IMT, which may indicate that we are generating potent immune responses especially in patients who match Bria-IMT at specific HLA types,” he added.
Dr. Charles Wiseman, scientific founder and director of BriaCell, said these very positive results are tremendously encouraging. “We documented actual shrinkage, and in some tumor sites, complete regression, with few side-effects, in this Phase 1/2a trial for terminal patients already resistant to chemotherapy.”
