- 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.
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.
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