- July 2022: BriaCell Partners with Waisman Biomanufacturing to Manufacture and Supply Prostate Cancer Immunotherapy
- June 2022: BriaCell Enters Research Agreement to Identify Novel Targets for Cancer Treatment
- April 2022: BriaCell receives FDA fast-track approval for targeted breast cancer immunotherapy.
- February 2022: BriaCell appoints renowned oncologist, Dr. Giuseppe Del Priore as chief medical officer, appoints immunologist Dr. Alexander Kharazi to its advisory board, and adds two clinical trial sites to accelerate patient enrollment.
- December 2021: BriaCell announces insiders' intention to purchase up to 10 percent of public market securities.
- September 2021: BriaCell announces securities buyback to purchase up to 10 percent of common shares and up to 10 percent of listed warrants.
- July 2021: BriaCell Phase I/IIa clinical trial combination study in advanced breast cancer patients opens for enrollment.
- June 2021: BriaCell Therapeutics announces closing of US$27.2 million private placement
- June 2021: BriaCell Reports 12.0 months overall survival benefit in advanced breast cancer; 100 percent resolution of ‘eye-bulging’ tumor
- February 2021: BriaCell announces closing of US$25 million public offering and listing on NASDAQ.
- August 2022: Briacell secured an exclusive license from University of Maryland, Baltimore County (UMBC) to develop and commercialize Soluble CD80 (sCD80) as a biologic agent for the treatment of cancer.
- September 2022: Briacell signed an agreement with Caris Life Sciences to develop immunotherapies that are personalized for each patient by expanding patient outreach and molecular profiling.
At the forefront of cancer treatments, immunotherapies boost the ability of the body's own cancer-fighting cells to destroy cancerous tumors. Immunotherapies also have low-toxicity, making it easier for patients to undergo treatment. Most importantly, they may offer better efficacy and less chance of recurrence for many cancer patients. In a report released by Research and Markets, the global immuno-oncology market is expected to reach US$135 billion by 2024. BriaCell continues to uncover opportunities in this space with its innovative technologies.
With a recently-awarded Fast Track status from the FDA, BriaCell's lead candidate, Bria-IMT™, is an immunotherapy currently being developed to treat advanced breast cancer, which is the expected cause of over 43,000 deaths in the US in 2022. Bria-IMT™achieved positive proof of concept, showing outstanding safety and efficacy data. Importantly, preliminary efficacy data was similar, or superior to, those of other approved breast cancer drugs when they were at a similar stage of clinical development. After significant success, BriaCell received FDA Fast Track designation for this targeted immunotherapy approach.
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 be evaluating novel combinations of compounds from Incyte's development portfolio with BriaCell's drug candidates in advanced breast cancer patients.
BriaCell has been dosing patients in a Phase I/IIa combination study of BriaCell’s lead candidate, Bria-IMT™, with Incyte’s checkpoint inhibitor, retifanlimab provided under corporate collaboration with Incyte. The combination study is listed in ClinicalTrials.gov as NCT03328026.
BriaCell is also developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient, without the need for personalized manufacturing. Bria-OTS™, which is expected to match over 99 percent of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics associated with other personalized immunotherapies
In November 2020, BriaCell announced a Cooperative Research and Development Agreement with the National Cancer Institute (NCI, Center for Cancer Research), part of the National Institutes of Health, to investigate key aspects of novel off-the-shelf personalized therapeutics for cancer.
BriaCell's management team comprises a team of experienced industry leaders involved in the approval of over a dozen drugs.
The Cancer Immunotherapy Space
There are a number of challenges that cancer immunotherapy treatments face. Approved immunotherapies work in 20 to 30 percent of patients. They depend on the patient's weakened immune system; and, in some cases, can cause autoimmune disease.
Other challenges include the lack of effectiveness of cancer immunotherapies to treat some solid tumors or blood cancers, since they only work in certain types of cancer and not in others. Additionally, other effective personalized immunotherapies such as PROVENGE® and CAR-T need to be individually manufactured for each patient. This means a complex and time-consuming manufacturing process, which is extremely expensive and might make the therapies commercially unsuccessful.
In response to these challenges, BriaCell is developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer, which has been estimated to have caused over 43,000 deaths in the US in 2022.
The off-the-shelf approach means that the treatments are pre-manufactured and the patient will be able to receive personalized, targeted treatment using an easy and common human leukocyte antigen (HLA) test on their saliva sample. This approach is quick, relatively inexpensive, and avoids the complex manufacturing process associated with other personalized immunotherapy treatments. This approach is the first of its kind for advanced breast cancer.
Bria-IMT™, BriaCell'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. BriaCell believes that Bria-IMT™ helps the body to stimulate cancer-fighting T-cells, cells that directly attack tumor cells, and B-cells that produce anti-tumor antibodies.