· Interim data indicate an excellent safety profile for the combination regimen in advanced breast cancer patients. Initial efficacy data is expected in first quarter of 2019;
· Confirmed positive proof-of-concept with Bria-IMT™ Monotherapy demonstrates promising anti-tumor activity with excellent safety and tolerability in advanced breast cancer patients.
BERKELEY, Calif., and VANCOUVER, British Columbia, December 6, 2018 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, announces the presentation of initial safety data in the combination study of its lead candidate, Bria-IMT™, with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)] and confirmation of positive proof of concept data of Bria-IMT™ for advanced breast cancer at the 2018 San Antonio Breast Cancer Symposium (SABCS®). The combination study is listed in ClinicalTrials.gov as NCT03328026.
“I am very excited about our data continuing to show robust biological activity of Bria-IMT™ in advanced breast cancer,” commented Dr. Bill Williams, BriaCell’s president & CEO. “These findings also reinforce our product development strategy for Bria-OTS™, BriaCell’s novel off-the-shelf personalized immunotherapy, by showing predictability of the anti-tumor responses in patients using a relatively simple and inexpensive HLA test.
“Based on the data of three proof of concept studies to-date, Bria-IMT™ has shown the ability to produce powerful immune responses and elicit tumor regression even in heavily pre-treated patients with very advanced disease. We are highly confident of our strategy to use Bria-IMT™ in combination with KEYTRUDA®, an approved treatment for multiple cancer indications, and expect synergistic activity of this combination in patients with advanced breast cancer. We look forward to additional clinical data and expect to share details at upcoming scientific meetings.”
Highlights of the Poster Presentation at SABCS®
Initial safety data on the Bria-IMT™/KEYTRUDA® combination study and additional confirmatory Phase I/IIa data from the Bria-IMT™ monotherapy study, a subset of which was the subject of a previous press release, was presented this morning in detail by Saveri Bhattacharya, DO, assistant professor of Medical Oncology at Thomas Jefferson University and researcher at the NCI-designated Sidney Kimmel Cancer Center – Jefferson Health.
Title: Initial safety and efficacy of a phase I/IIa trial of a modified whole tumor cell targeted immunotherapy in patients with advanced breast cancer
Bria-IMT™ Combination Study with KEYTRUDA®: In the combination therapy study, five patients have been treated with the Bria-IMT™/KEYTRUDA® combination to date. Initial data on the combination of the Bria-IMT™ regimen with KEYTRUDA® suggests the combination is very safe and well tolerated. The study remains ongoing.
BriaCell is on track to present initial efficacy data on the combination in 1Q19.
Bria-IMT™ Phase I/IIa Monotherapy Study: Twenty-three patients have been dosed with Bria-IMT™ in the monotherapy study. The patients were very heavily pre-treated and had advanced breast cancer with a median of four prior systemic therapy regimens. Treatment was generally safe and well tolerated with no related grade >3 or unexpected adverse events. The most common adverse event was expected minor local irritation at the injection sites. Efficacy data showed tumor shrinkage in three patients, all of whom matched Bria-IMT™ at least at one HLA type. One patient, the top respondent, previously received seven chemotherapy regimens, and had tumors in the liver, bone and 20 different breast cancer nodules in the lungs. She matched Bria-IMT™ at Class I & II HLA types. Imaging analysis at three months showed disappearance or reduction of all 20 tumors in the lungs. This response was maintained at six months. Another patient matched Bria-IMT™ at one HLA type and had tumor reduction in the skin. A third patient had tumor reduction in the breast. Biological activity was also seen in several patients as evidenced by decreases in circulating cancer-associated cells, potentially also indicating anti-tumor activity of the Bria-IMT™ regimen. This was more frequently seen in patients with HLA matching to Bria-IMT™. In summary, all patients with tumor shrinkage matched with Bria-IMT™ at one or more HLA type, suggesting HLA matching may be a good predictor of anti-tumor activity of Bria-IMT™ in advanced breast cancer patients.
Activation of T cells, an important component of the immune system, was measured by delayed-type hypersensitivity (DTH) testing during treatment. Even though 60% of the patients could not mount a DTH response to a common yeast, Bria-IMT™ treatment elicited a DTH response in 59% of the patients and this was particularly robust in the patients with tumor regression. This indicates Bria-IMT™ elicits a robust immune response in these patient population.
Following the presentation, copies of the abstract and the poster will be posted on http://briacell.com/investor-relations/presentations/.
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 2018 SABCS®, please visit: https://www.sabcs.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™, its lead candidate, in a combination study with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc.]. The combination study is listed in ClinicalTrials.gov as NCT03328026.
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 90% 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 website: http://www.BriaCell.com.
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