Safety and early efficacy data were presented on December 12th at 6:00 p.m. ET from the clinical trials of Bria-IMT™ in combination with immune checkpoint inhibitors in advanced breast cancer:
• Continued additive or synergistic activity observed in combination study of Bria-IMT™ with pembrolizumab (KEYTRUDA®; by Merck & Co., Inc.) as evident by tumor shrinkage even in the absence of “HLA Matching”.
• Additional potential selection criteria identified: women with moderately-well differentiated tumors had a higher response rate.
• First patient data from Bria-IMT™ in combination with INCMGA00012 (from Incyte Corporation).
BERKELEY, Calif., and VANCOUVER, British Columbia, December 13, 2019 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce the presentation results of clinical studies with its lead product candidate, Bria-IMT™, summarized in two poster sessions during the 2019 San Antonio Breast Cancer Symposium® (SABCS).
The December 12th poster summarized data of the Bria-IMT™ monotherapy study and the ongoing Phase I/IIa clinical study of Bria-IMT™ in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012, in advanced breast cancer. The December 13th poster presentation this evening will address early predictors of effectiveness of the Bria-IMT™ regimen in advanced breast cancer.
Details and results on the poster presentations are summarized below:
Presentation Title: Efficacy and safety of a modified whole tumor cell targeted immunotherapy in patients with advanced breast cancer alone and in combination with immune checkpoint inhibitors
Session Date: Thursday, December 12, 2019 at 6:00 p.m. ET
• Eleven patients enrolled in the combination of the Bria-IMT™ regimen with KEYTRUDA®. Of 10 women with data available, BriaCell reasonably anticipated a response in 3 patients after assessment of immune response capability, HLA match and tumor differentiation (described further below). Tumor shrinkage was noted in 2 of these 3 patients.
• The remarkable responder treated with the combination of Bria-IMT™ with KEYTRUDA® disclosed on September 19, 2019 remains on study, and she has now transitioned to combination with Incyte’s INCMGA00012 – she had a 26% reduction in the breast cancer tumor size in the adrenal gland, and a 35% tumor size reduction in all tumor sites.
• Tumor reduction in Bria-IMT™ and KEYTRUDA® combination in a patient without HLA matching as disclosed on April 3, 2019. Notably this patient had a moderately well-differentiated tumor.
• Analysis of the combination study data indicates that women with tumors that are moderately-well differentiated (that look more like normal breast tissue) have a high rate of tumor shrinkage (25% or more tumor shrinkage in 2 of 3 patients). Notably, the Bria-IMT™ cell line was derived from a patient who ALSO had a moderately-well differentiated tumor. This points to a new way to select the patients most likely to respond in addition to our HLA matching hypothesis.
• Reanalysis of BriaCell’s 2018 monotherapy study data shows that, of 6 patients with moderately or well differentiated tumors, 2 of the 6 had definite tumor shrinkage. Two of the 6 patients had 2 or more HLA matches; the same 2 with definite tumor shrinkage.
• Initial information on the first patient treated with the combination of the Bria-IMT™ regimen with INCMGA00012 shows no serious adverse events and preliminary clinical benefit. Recruitment is ongoing.
Presentation Title: Circulating cancer associated macrophage-like cells (CAMLs) are early predictors of response to new line therapies in metastatic breast cancer
Session Date: Friday, December 13, 2019 at 6:00 p.m. ET
• In this poster, cancer associated macrophage-like cells (CAML), specialized myeloid cells found in peripheral blood and associated with the presence of solid tumors, was measured to determine their prevalence, specificity, and sensitivity in advanced breast cancer patients who were treated with Bria-IMT™ regimen.
• Patients with decreases in CAML size during treatment with the Bria-IMT™ regimen, alone or in combination with KEYTRUDA®, or other therapies, appear to be more likely to respond to treatment with tumor reduction and have a longer disease-free survival.
Copies of the posters will be posted at the following: https://briacell.com/novel-technology/scientific-publications/.
“We are intrigued by the initial data for Bria-IMT™ in combination with checkpoint inhibitors in advanced breast cancer patients suggesting additive or synergistic effects,” said Dr. Bill Williams, President & CEO of BriaCell. “The identification of a novel subset of patients with a very high response rate, if confirmed with further clinical evaluation, will allow us to focus our development plans on the patients most likely to benefit. We plan to provide additional data as we continue to treat breast cancer patients with novel combinations of Bria-IMT™ with checkpoint inhibitors.”
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/.
Since its inception in 1977, San Antonio Breast Cancer Symposium (SABCS®) has grown to a five-day program that covers the latest research on the experimental biology, etiology, prevention, diagnosis, and treatment of breast cancer and premalignant breast disease. The Symposium is attended by a large international audience of researchers, health professionals, physicians, oncologists, and those with a special interest in breast cancer from over 90 countries.
To complement the clinical focus of the annual SABCS®, Baylor College of Medicine became a joint sponsor of SABCS® in 2005. Additionally, the Cancer Therapy & Research Center (CTRC) at UT Health Science Center San Antonio and American Association for Cancer Research (AACR), a prestigious scientific organization known for its basic, translational and clinical cancer research, began collaboration with SABC® in 2007. The Symposium was renamed the CTRC-AACR San Antonio Breast Cancer Symposium.
For additional information on 2019 SABCS®, please visit: https://www.sabcs.org.
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