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BriaCell Therapeutics Corp. (TSXV: BCT) (OTC: BCTXF) continues to enroll patients in its Phase 1/2a clinical trial of BriaVax™ for the treatment of advanced breast cancer. The third patient enrolled earlier this week, making it three patients over the past three months. Management is expecting that pace to accelerate in the coming weeks, and now believes that the first ten patients will enroll by the end of September 2017. An interim data analysis of these first ten patients should be available during the first quarter 2018, setting up a nice potential catalyst for the shares.

Reporting data on BriaVax in patients with advanced metastatic breast cancer will be an important milestone for the company and represents many years of hard work by management to get BriaVax back into human clinical trials. I think BriaVax has tremendous potential as a targeted immunotherapy, so I’m excited to see the company moving forward and a nice catalyst on the horizon.

The Phase 1/2a Program

The Phase 1/2a trial (NCT03066947) is expected to enroll up to 24 late-stage cancer patients with recurrent and/or metastatic breast cancer who have failed at least one line of prior therapy (ECOG 0-2). The single-arm, open-label study is designed to determine the optimal dosing regimen and safety profile of the targeted immunotherapy. The primary endpoint is the incidence of treatment-emergent adverse events following multiple injections of BriaVax. The current protocol calls for inoculation of the vaccine at baseline and then every 2 weeks for one month (3 treatments), then monthly for up to one year. The interim analysis will focus on safety and on the dosing regimen.

Important secondary outcome measures include overall survival (OS), objective response rate (ORR), progression free survival (PFS), and durability of tumor response. Patient quality of life, performance status, weight, and pain will also be measured. Subsequent to the interim analysis, the company may escalate or decrease the BriaVax dose based on the emerging data.