BriaCell Presents Encouraging Clinical Data

BriaCell Therapeutics Corp., an immuno-oncology-focused biotechnology company with a proprietary targeted immunotherapy technology, recently announced it presented a late-breaking poster presentation at the Annual Meeting of the American Association for Cancer Research (AACR) held April 14-18, 2018, at McCormick Place North/South, Chicago, IL. The poster highlighted the preliminary safety and efficacy of its lead product candidate, Bria-IMT. Dr. William Williams, BriaCell’s President and CEO, discussed the latest update on the company’s clinical trial of Bria-IMT in patients with advanced breast cancer. BriaCell is currently enrolling patients in a Phase IIa trial (NCT03066947) with Bria-IMT and a rollover trial (NCT03328026) with Bria-IMT alone or in combination with other immunotherapies.

A reference to the abstract can be accessed via the following link: http://www.abstractsonline.com/pp8/#!/4562/presentation/11287. Following the presentation, copies of the abstract and the poster were posted on http://briacell.com/investor-relations/presentations/.

The poster described preliminary findings on safety and efficacy of Bria-IMT in patients enrolled in the ongoing study WRI-GEV-007, A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients, listed in ClinicalTrials.gov as NCT03066947, and evaluated the hypothesis that patients who match Bria-IMT for HLA type may have enhanced tumor response to the Bria-IMT regimen.

“The results presented add to the growing body of evidence for the clinical utility of Bria-IMT,” said Dr. Bill Williams. “We are very pleased with the results we have seen to date and looked forward to presenting them to the scientific community at AACR. We believe our data supports the use of HLA typing in advanced breast cancer patients to select those most likely to respond to Bria-IMT, and bolsters our decision to develop Bria-OTS, the first off-the-shelf personalized immunotherapy for breast cancer, along with, BriaDX, its companion diagnostic test, to bring hope to advanced breast cancer patients with far too few effective treatment options.”

BriaCell is an immuno-oncology-focused biotechnology company developing a targeted and safe approach to the management of cancer. Immunotherapy has come to the forefront in the fight against cancer, harnessing the body’s own immune system in recognizing and selectively destroying cancer cells while sparing normal ones. Immunotherapy, in addition to generally being more targeted and less toxic than commonly used types of chemotherapy, is also thought to be a potent approach with the potential to prevent cancer recurrence.
Bria-IMT (SV-BR-1-GM), the company’s lead product candidate, is derived from a specific breast cancer cell line. It is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. We believe that Bria-IMT helps the body to recognize and kill tumor cells by activating T cells that attack the tumor and B cells that produce anti-tumor antibodies.

The results of two previous proof-of-concept clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with Bria-IMT) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to Bria-IMT with substantial reduction in tumor burden, including breast, lung, soft tissue, and brain metastases. BriaCell is currently conducting a Phase I/IIa clinical trial for Bria-IMT in patients with advanced breast cancer. In this trial, Bria-IMT treatment appeared safe with similar instances of tumor reduction as those observed in the earlier proof-of-concept trials. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDX, the company’s companion diagnostic test. Additionally, the FDA recently approved the roll-over combination study of Bria-IMT with pembrolizumab [Keytruda; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy; manufactured by Bristol-Myers Squibb Company] for patients previously treated with Bria-IMT in the company’s ongoing Phase I/IIa clinical trial in advanced breast cancer. The roll-over trial is listed in ClinicalTrials.gov as NCT03328026. For more information, visit www.briacell.com.