Focusing initially on breast cancer, BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX:BCT) is dedicated to developing novel immunotherapies to fight cancer and improve patients’ lives. Immunotherapies have become the forefront of the fight against cancer because they use the body’s immune system to destroy cancer cells, offer the potential for higher levels of safety and efficacy than chemotherapy, and may also prevent cancer recurrence.
The pivotal Phase 3 combination study is listed on ClinicalTrials.gov as NCT06072612.
Bria-IMT™ was awarded Fast Track status by the U.S. Food and Drug Administration (FDA).
BriaCell recently announced completion of enrollment of advanced breast cancer patients in its randomized ongoing Phase 2 combination study of Bria-IMT™ with Incyte’s immune checkpoint inhibitor, retifanlimab. This study followed successful completion of a Phase 1 study showing a favorable safety and efficacy profile for the combination regimen. The combination study is listed on ClinicalTrials.gov as NCT03328026. The study follows a successful completion of a Phase 1 study demonstrating a favorable safety and efficacy profile for the combination regimen.
Collaboration with Incyte: BriaCell currently has a non-exclusive clinical trial collaboration with Incyte (Nasdaq: INCY) to evaluate the effects of combinations of novel clinical candidates. Under the agreement, Incyte and BriaCell will evaluate novel combinations of compounds from Incyte’s development portfolio with BriaCell’s drug candidates in advanced breast cancer patients.
Bria-OTS™*: Awarded a patent by the USPTO, BriaCell is developing Bria-OTS™, a novel personalized “off-the-shelf” immunotherapy for the treatment of advanced stage breast cancer.
BriaCell received a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI), and has an ongoing collaboration with the NCI, Center for Cancer Research, part of the National Institutes of Health, to investigate the mechanism of action of novel personalized off-the-shelf therapeutics for cancer.
* The continuation and completion of these studies depends on BriaCell securing adequate capital to execute these studies.
BREAST CANCER: FACTS & STATISTICS
- According to a report published by the American Cancer Society in 2024, approximately 611,720 Americans are expected to die from cancer in 2024 (approximately 1,676 deaths per day), making cancer the second leading cause of death in the U.S., exceeded only by heart disease.
- As of January 2024, the number of women in the U.S. with a history of invasive breast cancer is estimated to be 4 million. Approximately 30% of breast cancers occur in women younger than age 50 and 44% occur in women older than age 65.
- According to an American Cancer Society in 2024 fact sheet, 310,510 women and 2,790 men are expected to be diagnosed with invasive breast cancer in 2024 in the U.S. alone. Breast cancer is the most frequently-diagnosed cancer in women in the U.S.
- Breast cancer deaths in 2024 are estimated to be 42,780 (42,250 women, 530 men), making breast cancer the second leading cause of cancer death in women (after lung cancer).
- As reported by the American Cancer Society in 2024, approximately 62% of breast cancer cases are detected at the 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 to be 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 cancer), the 5-year survival rate falls to as low as 27% (i.e. 73% of the patients die within 5 years). This shows the significant need for effective treatments for this deadly cancer.