BriaCell Therapeutics Corp. provided a clinical update regarding its ongoing clinical trials of Bria-IMT™ (formerly referred to as SV-BR-1-GM). BriaCell currently is enrolling patients in two separate but related clinical trials. Trial WRI-GEV-007 (listed in ClinicalTrials.gov as NCT03066947) is a Phase I/IIa clinical study designed to evaluate the safety and efficacy of Bria-IMT™ in metastatic or locally recurrent breast cancer patients. In this study, Bria-IMT™ is given in a regimen including low-dose pre-dose cyclophosphamide (to reduce suppression of the immune response) and post-dose interferon-alpha (to boost the immune response). The second clinical trial, BRI-ROL-001 (listed in ClinicalTrials.gov as NCT03328026), is a rollover study of Bria-IMT™ in combination with Keytruda® [pembrolizumab] or Yervoy® [ipilimumab]. Patient recruitment is on schedule despite interruption due to temporary shutdown of some clinical sites, affected by wildfires and hurricanes. Seven patients have enrolled in the WRI-GEV-007 clinical trial with 6 treated to date (1 patient dropped out after cyclophosphamide pre-treatment and did not receive Bria-IMT™). Based on results to-date, Bria-IMT™ has been very well tolerated and the majority of adverse events were limited to expected minor local irritation at the injection sites. No serious adverse events related to Bria-IMT™ have been reported and no new or unexpected safety issues related to Bria-IMT™ have been observed. The Phase I portion of the study has been successfully completed, and the Phase IIa portion is currently enrolling. One patient is worth discussing in detail. This 73-year-old woman had breast cancer diagnosed in 1995. She developed liver metastases in 2010, and then lung metastases in 2017. Prior treatments included surgery, radiation therapy, hormonal therapy and seven rounds of chemotherapy with 8 different chemotherapy agents. She received 5 cycles of Bria-IMT™ over the first 3 months of treatment, then 3 additional cycles over the following 3 months (6 months total). Evaluation was performed after 3 months and 6 months. After 3 months, despite the extensive prior therapy, her scans noted that, “there has been a clear response in the multiple bilateral pulmonary nodules” indicating that several lung tumors had disappeared or decreased in size. This response was maintained after 6 months of treatment with Bria-IMT™. The liver tumors were stable to slightly increased at 3 months, and then progressed after 6 months. A third clinical site was recently added to the study and several patients are being evaluated for the WRI-GEV-007 study. Discussions are ongoing with two additional clinical sites which are expected to be added in the near future. The combination rollover study, BRI-ROL-001, is available to enroll patients. Other activities remain on track. The companion diagnostic, BriaDX™, has been bolstered by the important supporting data for the HLA biomarker matching hypothesis noted above. BriaCell is also developing an off-the-shelf, personalized immunotherapy (Bria-OTS™) to treat a much wider patient population (with ~90% of the population being a double-match with Bria-OTS™). In collaboration with University of Zurich, Switzerland, BriaCell is testing other drugs/product candidates that are expected to boost the effectiveness of Bria-IMT™ and Bria-OTS™. Ongoing work in the small molecule program to select protein kinase C delta inhibitors for cancer and fibrotic diseases is also progressing according to its timelines. The medicinal chemistry work is being performed at Colorado State University where the current library of compounds available is being augmented.