BriaCell Therapeutics (NASDAQ:BCTX,NASDAQ:BCTXW,TSX:BCT) CEO Dr. William V. Williams discusses the US Food and Drug Administration (FDA) fast-track status the company received for its breakthrough immunotherapy cancer treatments. According to Dr. Williams, this is a new cellular type of therapy for patients with very serious breast cancer who didn’t respond to other treatments.

An estimated 7.8 million women are diagnosed with breast cancer over a five year span, according to a World Health Organization study. The Cleveland Clinic notes that there is a 6 percent recurrence rate within five years. There are varied types of breast cancer , and not all patients respond to treatment such as chemotherapy.

According to the National Institutes of Health, immunotherapy is a promising way to treat unresponsive patients. Through genetic identifiers , companies like BriaCell are developing breakthrough treatment options. Dr. Williams detailed the process, saying, “Cells which have been genetically modified to produce a stimulator of the immune system are grown in tissue culture. We take them in and irradiate them so they can't grow anymore, then freeze them down so they're stable. We can ship them frozen to the clinic, and they can treat the patients by injecting them in the skin in order to induce an immune response against the breast cancer cells.”

Dr. Williams said about the process, “Our therapy is given in combination with a couple of other drugs to boost the response. And currently, we're looking at three week cycles of this treatment for the patients. With Bria-IMT™, we saw some really remarkable responders in selected patient subgroups. More recently, we’re looking at it in combination with immune checkpoint inhibitors. The FDA recognizes this, and the very good safety profile. Because of that they granted us the fast-track designation.”

This will enable BriaCell to rapidly advance this promising therapy through clinical trials so that patients can have access to it as soon as possible. Thus far, studies show that patients matching a Bria-IMT immunotherapy cell line, what's called the human leukocyte antigen (HLA) type , are the most likely to respond well. The HLA molecules are the molecules that start immune responses, but they're different in different people. Because of the improved response, the company has genetically engineered its Bria-IMT cells to express multiple different HLA types.

According to Dr. Williams, “The patients will come in, they'll have their HLA type testing done — a simple saliva test. Once we know their HLA type, we can ship the matching cells overnight to the clinic and they can be treated with an immunotherapy that's personalized and off the shelf, which allows us to avoid a lot of the complex manufacturing problems that many other personalized immune therapies have encountered.”

Dr. Williams also noted, “We're really excited to be on the cutting edge of this science and getting good patient responses. Now, with the fast-track designation, we're moving forward full steam with our Bria-IMT. It’s a very exciting year for our company, we think it's going to be a transformational year.”

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