BriaCell Therapeutics Corp. (OTC: BCTXF) (TSX.V: BCT)

Tip on: September 17, 2018

BriaCell Therapeutics Corp. (TSX-V: BCT) (OTC: BCTXF), based in Berkeley, CA, and headquartered in Vancouver, British Columbia, is a clinical-stage biotechnology company focused on the development of targeted immunotherapy for advanced breast cancer.

BriaCell hopes to develop and market the first off-the-shelf personalized immunotherapy for the treatment of advanced breast cancer.

The results of two previous proof-of-concept clinical trials produced encouraging results in patients with advanced breast cancer. Most notably, one patient with breast cancer that had spread to other sites (metastatic cancer) responded to Bria-IMT™ with a substantial tumor shrinkage in multiple sites including the breast, the lung, soft tissues and even the brain. Similar observations have been confirmed more recently in additional patients, and BriaCell is developing BriaDX™ as a way to identify those patients most likely to respond.

BriaCell has recently completed recruitment of a Phase I/II study (NCT03066947) of Bria-IMT™, the Company’s lead product candidate, in advanced breast cancer patients showing an outstanding safety profile and excellent efficacy. BriaCell is currently enrolling advanced breast cancer patients in a combination therapy trial (NCT03328026) of Bria-IMT™ with Keytruda® (Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.) or Yervoy® (Yervoy® is a registered trademark of Bristol-Myers Squibb Company). For further information on the Phase IIa clinical trials, please visit trial NCT03066947 and trial NCT03328026.

BriaCell’s pipeline also includes Bria-OTS™, the first off-the-shelf personalized immunotherapy for advanced breast cancer; and, a companion diagnostic product BriaDX™. By using BriaDX™ to identify and treat the patients who would most likely benefit from their immunotherapies, BriaCell expects to personalize the treatment for the patients, and bring hope to thousands of cancer patients who currently have few-to-no treatment options.

Breast Cancer Statistics

The National Cancer Institute estimates that more than 265,000 new cases of female breast cancer will be diagnosed in the U.S. during 2018, and that more than 40,000 women in the U.S. will die from the disease. Approximately 12 percent of women will be diagnosed with breast cancer at some point during their lifetime, based on 2013-2015 data.

Using its novel technology platform and strong R&D capabilities, BriaCell believes it has the opportunity to address this market, as well as have the opportunity to develop immunotherapy candidates for other cancer indications.

The global cancer immunotherapy market is expected to reach nearly USD$203 billion by 2025.

Investment Considerations
  • Developing the first off-the-shelf personalized immunotherapy for advanced breast cancer, Bria-OTS™. Bria-OTS™ is designed to provide personalized treatment for ~90% of the advanced breast cancer patients without the high costs and difficult manufacturing associated with personalized treatments. The technology may be applicable to other cancers.
  • Addressing an unmet need by targeting advanced breast cancer, from which an estimated 40,000 women have died in U.S. in 2017
  • $1 billion-$5 billion market opportunity depending on patient treatment stage
  • Results of two completed proof-of-concept human clinical trials showed rapid tumor shrinkage at multiple sites in advanced breast cancer patients without toxicity associated with other oncology treatments (e.g. chemotherapy).
  • Bria-IMT™ has completed enrollment of a Phase I/IIa clinical trial with outstanding safety data and early signs of potent efficacy. Preliminary data from the Phase I/IIa trial is expected in 3Q2018.
  • BriaDX™, a companion diagnostic test, is currently in development along with Bria-IMT™ and Bria-OTS™.
  • Experienced management has been involved in over 10 drug approvals
  • Significant near-term news-flow

BriaCell Therapeutics Corp. Website