Introduction

I. About BriaCell

Dedicated to enhance the lives of cancer patients who are facing limited therapeutic options, BriaCell Therapeutics Corp. (OTCQB: BCTXF; TSX: BCT.V)’s mission has been to develop novel immunotherapies, as the most cutting edge technology to fight cancer. Immunotherapies have become the forefront of the cancer treatments because they use the body’s immune system to destroy the cancer cells, offering higher levels of safety and efficacy than chemotherapy, with less likeliness of recurrence.

Designed by our team of scientists and clinicians, BriaCell’s proprietary whole-cell based technology platform continues to show its impressive potential to establish a new model for treating cancer patients. Our lead product candidate, Bria-IMT™ (SV-BR-1-GM), is a genetically engineered whole-cell based product candidate derived from a human breast cancer cell line. Bria-IMT™ is used in combination with multiple immune-modulators to powerfully trigger the immune system to recognize and eliminate cancerous cells.

In a preliminary Phase I clinical study in metastatic (i.e., Stage IV) breast cancer patients who had failed multiple treatments, Bria-IMT™ treatment significantly reduced the tumor size, without serious side effects. Importantly, the tumor regression was observed in other sites including the lung and even the brain -a difficult site. Impressively, the median lifespan of the patients was substantially longer than that of the comparable trials.

At our laboratory facility in Berkeley, CA, we are planning to expand our pipeline of oncology immunotherapy candidates using our proprietary technology platform.

Using the clinical data from the patients from the clinical studies, we are working to identify the molecular fingerprint of the patients for which Bria-IMT™ would be highly effective, and are planning to develop diagnostic testing products to identify this group. By directing the drug to the top-responders, we expect this approach to increase the likelihood of clinical trial success of Bria-IMT™ -to bring hope to thousands of cancer patients with few-to-no treatment options.

The company recently achieved positive proof-of-concept in a Phase I/IIa clinical trial for its lead product candidate, Bria-IMT™, in patients with advanced breast cancer (ClinicalTrials.gov as NCT03066947). The trial was being conducted along with the co-development of BriaDX™, the company’s companion diagnostic test. Currently, BriaCell is conducting an FDA approved combination study of Bria-IMT™ with pembrolizumab [Keytruda; manufactured by Merck & Co., Inc.] for patients with advanced breast cancer (ClinicalTrials.gov as NCT03328026). Capitalizing on insights gained with Bria-IMT™, BriaCell is developing Bria-OTS™, the first “off the shelf” personalized immunotherapy for the treatment for advanced stage Breast Cancer. Finally, BriaCell’s small molecule program consists of novel, selective protein kinase C delta inhibitors which have shown activity in pre-clinical models of several cancers and fibrotic diseases. BriaCell maintains global rights for Bria-IMT™.

II. Breast Cancer: Facts & Statistics

  • According to the report published by the American Cancer Society in 2018, approximately 609,640 Americans are expected to die of cancer in 2018 (approximately 1,670 deaths per day), making cancer the second leading cause of death in the US, exceeded only by heart disease.
  • As of January 2018, the number of women with the history of invasive breast cancer is estimated at 3.1 million (excluding the estimated 268,670 new cases in 2018). The number is expected to increase by 12% to 4 mil in 2024. Approximately 20% of breast cancers occur in women younger than 50 and 43% occur in women older than 65.
  • According to the facts and figures released by the American Cancer Society in 2018, 266,120 of women, and 2,550 of men are expected to be diagnosed with invasive breast cancer in 2018 in the US alone. Excluding skin cancer, breast cancer is the most frequently diagnosed cancer in women in the US.
  • Breast cancer deaths in 2018 are estimated at 41,400 (40,920 women, 480 men), making breast cancer the 2nd leading cause of cancer death in women (after lung cancer).
  • As reported by the American Cancer Society in 2018, approximately 62% of breast cancer is detected in early stages (i.e., the cancer is found in the breast tissue, and has not spread to lymph nodes or other regions of the body), for which the 5-year survival rate is estimated at 99%. As soon as the cancer spreads to lymph nodes under the arm or nearby tissues (regional stage), the 5-year survival rate drops to 83%. However, once the cancer spreads to other lymph nodes or body parts {distant stage or metastatic (met-uh-STAT-ic) cancer}, the five year survival rate falls to as low as 27% (i.e. 73% of the patients die within 5 years). This shows the grave need for effective treatments for this deadly cancer.