- BriaCell is on its way to developing a personalized, off-the-shelf immunotherapy for advanced breast cancer patients
- Because of the market gap and the demand for such treatments, the development and release of the product could be fast tracked
- BriaCell has obtained excellent results in clinical trials so far as Bria-IMT demonstrates the ability to shrink tumors at multiple sites in patients with advanced breast cancer
BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT) is developing the first personalized, off-the-shelf advanced breast cancer immunotherapy option using its proprietary targeted immunotherapy technology, company president and CEO Dr. Bill Williams said in a recent interview with Stock Day’s Everett Jolly (http://ibn.fm/EvrXz).
The biotechnology company focuses its efforts on immuno-oncology and is known for its proprietary targeted immunotherapy technology, which makes it possible to offer off-the-shelf personalized treatments for advanced breast cancer patients. According to Williams, the off-the-shelf personalized treatment that BriaCell is developing will be similar to other forms of personalized immunotherapy that are time consuming and costly to produce due to a complex manufacturing process.
Immunotherapy is on the forefront of the battle against cancer. BriaCell is putting all of its effort and resources into the development of treatment options that are highly effective and safe at the same time, Williams explained.
Currently, BriaCell Therapeutics has two major programs – Bria-IMT and Bria-OTS. Bria-IMT is currently in the clinic, while Bria-OTS is in the process of development, Williams said. Previous clinical testing of Bria-IMT has returned promising results. In a clinical trial for the treatment of advanced breast cancer, Bria-IMT contributed to tumor shrinkage in multiple sites (in patients with metastases). Through additional patient testing, the original observations were confirmed.
The company is in Phase 2a clinical testing of its Bria-IMT in combination with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)]. The combination study is listed on ClinicalTrials.gov as NCT03328026.
Bria-OTS is being developed on the basis of results obtained in the Bria-IMT clinical trials. Through its development, BriaCell Therapeutics will be genetically engineering immunotherapy cell lines which will induce specific immune responses against the cancer. The aim of such therapies is to target breast cancer tumors and induce an immune response in a way that’s personalized to the patient, Williams said. Such tailoring is possible through the use of an HLA allele matching system.
According to Williams, BriaCell plans to communicate with the Food and Drug Administration (FDA) about the design of a pivotal Bria-IMT registration trial in 2019. Following the completion of this step, BriaCell plans to start a registration study in 2020. The final Bria-IMT approval is expected by 2023. The personalized, off-the-shelf version of this therapy (Bria-OTS) is approximately two years behind in schedule in comparison to Bria-IMT.
Patients with advanced breast cancer have an unmet need at the moment, Williams noted. Because of the significant demand, the company’s immunotherapies may qualify for accelerated FDA review.
While other immunotherapies are currently available on the market, some patients have seen a poor response and others have experienced serious side effects. Through the use of targeted therapies like the ones developed by BriaCell, the immune response is generated in a specific way to target solely cancerous cells. Healthy tissue is unaffected, which contributes to the excellent tolerance demonstrated in the clinical trials.
According to Williams, numerous pharmaceutical companies are interested in BriaCell’s developments, and they’re simply waiting for more clinical data. “We have that data now and are just trying to put it into a format that we can share with people who are very scientifically advanced. We should be coming back to them within the next couple of months, hopefully generating some additional excitement,” he said.
For more information, visit the company’s website at www.BriaCell.com
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