BERKELEY, Calif., and VANCOUVER, British Columbia, May 28, 2019 — 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, today announced that BriaCell’s 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, taking place May 31-June 4, 2019 at the McCormick Place Convention Center in Chicago, IL, 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.
Abstract Title: Safety and efficacy of a phase I/IIa trial (NCT03066947) of a modified whole tumor cell targeted immunotherapy in patients with advanced breast cancer
Abstract No: e14026
Citation: J Clin Oncol 37, 2019 (suppl; abstr e14026)
Clinical data of 23 advanced breast cancer patients dosed with Bria-IMT™ in the completed Phase I/IIa clinical study (NCT03066947) 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. Importantly, these top-responder patients matched Bria-IMT™ at specific HLA 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™, BriaCell’s off-the-shelf personalized immunotherapy for advanced breast cancer, and BriaDX™, BriaCell’s companion diagnostic identification test. Bria-OTS™ is expected to receive FDA approval to begin clinical testing in late 2019.
For the copy of the abstract, please visit: http://abstracts.asco.org/239/AbstView_239_260919.html.
“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,” stated Dr. Williams, BriaCell’s President and CEO. “We are excited with the potential clinical benefits of Bria-IMT™ in combination with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)], and with INCMGA00012 and epacadostat [experimental drugs manufactured by Incyte (NYSE: INCY)] and look forward to sharing additional data in the second half of 2019.”
Abstract Title: Real-time monitoring of circulating stromal cells in the blood to predict responsiveness of new-line therapies in metastatic breast cancer
Abstract No: e14048
Citation: J Clin Oncol 37, 2019 (suppl; abstr e14048)
BriaCell participated in this 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. Hence, the use of blood sampling may predict the clinical value of the immunotherapy treatment early on and determine the best course of subsequent treatment for the patient.
For the copy of the abstract, please visit: http://abstracts.asco.org/239/AbstView_239_264031.html.
“These important findings should help us better monitor and evaluate the anti-tumor response to Bria-IMT™ in advanced breast cancer patients, and modify the course of treatment if necessary,” stated Dr. Lacher, BriaCell’s head of R&D. “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”.
Dr. Charles Wiseman, scientific founder and director of Briacell, commented, “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 I/IIa trial for terminal patients already resistant to chemotherapy. We have our marching orders to intensify our research, especially with the opportunity to combine Bria-IMT™ with some other promising new agents like KEYTRUDA®, INCMGA00012 and epacadostat. ”
BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™, its lead candidate, in a Combination Study with KEYTRUDA®. The Combination Study is listed in ClinicalTrials.gov as NCT03328026.
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 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.
For additional information on the 2019 ASCO’s Annual meeting, please visit https://www.asco.org/.
BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.
BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)]. The Combination Study is listed in ClinicalTrials.gov as NCT03328026.
BriaCell and Incyte Corporation (NASDAQ: INCY) have formed a non-exclusive clinical trial collaboration 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 Bria-IMT™ in advanced breast cancer patients.
BriaCell is 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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