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 vaccine technology platform continues to show its impressive potential to establish a new model for treating cancer patients. Our lead product candidate, BriaVax™, is a genetically engineered whole-cell vaccine derived from a human breast cancer cell line. BriaVax™ 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, BriaVax™ 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 vaccine 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 the vaccine 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 BriaVax™ -to bring hope to thousands of cancer patients with few-to-no treatment options.

The company plans to initiate a Phase I/IIa trial to further test BriaVax™ safety and activity in metastatic breast cancer patients. BriaCell maintains global rights for BriaVax™.

II. Breast Cancer: Facts & Statistics

  • According to the report published by the American Cancer Society in 2015, the number of cancer survivors in 2014 is estimated at 14.5 million people in the US alone.
  • As of January 2015, the number of women with the history of invasive breast cancer is estimated at 3.1 million (excluding the estimated 232,670 new cases in 2014). 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 2015, 231,840 of women, and 2,350 of men are expected to be diagnosed with invasive breast cancer in 2015 in the US alone. Excluding skin cancer, breast cancer is the most frequently diagnosed cancer in women in the US.
  • Breast cancer deaths in 2015 are estimated at 40,730 (40,290 women, 440 men), making breast cancer the 2nd leading cause of cancer death in women (after lung cancer).
  • As reported by the American Cancer Society in 2015, approximately 61% 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 85%. 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 25% (i.e. 75% of the patients die within 5 years). This shows the grave need for effective treatments for this deadly cancer.