BriaCell Announces Positive Phase IIa Data in Advanced Breast Cancer

From Globe Newswire BriaCell Therapeutics Corp. (“BriaCell”, the “Company”) (TSX-V: BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that it has achieved proof of concept in the Phase IIa study of its lead clinical candidate, Bria-IMT™, in advanced breast cancer. The Company will host a webcast at 4:15 p.m. ET today to discuss these results.

To further enhance the anti-tumor activity of Bria-IMT™, the Company will focus on the combination study of the candidate with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. The combination study is listed in ClinicalTrials.gov as NCT03328026.

To date, 31 advanced stage breast cancer patients have been enrolled in the Phase IIa Bria-IMT™ monotherapy study. The Phase IIa confirmatory mechanism of action and proof of concept work is based on the first 20 patients, with assessment of the remaining 11 patients in progress. Given the conclusive findings on the first 20 patients, enrollment for this monotherapy study is now closed, while enrollment for the combination study is open.

“Bria-IMT™ appears to be most effective in patients who match with Bria-IMT™ at 2 HLA loci (types) further supporting BriaCell’s HLA Matching Hypothesis, and the development of Bria-OTS™ to cover 90% of the patient population. We are delighted with these positive clinical findings that confirm our HLA Matching Hypothesis in the Phase I/IIa trial in advanced breast cancer showing significant tumor shrinkage without serious side effects,” stated BriaCell’s President and CEO Dr. Bill Williams. “We believe that combination studies with immune checkpoint inhibitors should create even more potent anti-cancer immune responses, leading to our strategy of combination studies of Bria-IMT™ with Keytruda® or Yervoy®.”

"This top-line data compares very well with data from existing breast cancer therapies which have a sizable market share when they were at a similar stage of clinical development, as well as with other promising breast cancer treatments currently under study. In our view, the combination of Bria-IMT™ with Keytruda® or Yervoy® has the potential to provide a new therapeutic option and substantial clinical benefit in heavily pre-treated advanced breast cancer patients where there remains a significant unmet need," Dr. Williams added.