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From: ayeyou12/18/2015 9:43:30 AM
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Dave@SI

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New BCT writeup in Life Sciences Report lest we forget the tiger we have by the tail...

Let Your Biotech Winners Ride into Orbit: Jason Napodano of BioNap Consulting RNN, BOTA, CANF, BCT, ATNM, RDHL, IMNP

TLSR: Jason, immunotherapy, especially in oncology, is a hot topic right now, and investors are head-over-heels for this category. You have an interesting name with a very low valuation under coverage, and it is developing a therapeutic immunization. Tell me about that.

JN: Sure. BriaCell Therapeutics Corp. (BCT:TSX.V) is a Canadian company—another very small company. I'm intrigued by what it's doing with a therapeutic cancer vaccine called BriaVax for women with late-stage metastatic breast cancer. This is very difficult to treat, there are limited treatment options and, unfortunately, it's a large population.

Therapeutic cancer vaccines have come a long way since Dendreon Corp.'s (DNDN:NASDAQ) failure with Provenge (sipuleucel-T) in prostate cancer. I think BriaCell really has something here. BriaVax is a proprietary whole cell tumor vaccine that was isolated from a chest-wall lesion of a woman with metastatic breast cancer many years ago. It's genetically modified to release granulocyte macrophage colony-stimulating factor (GM-CSF), which is a highly potent immunostimulatory molecule designed to induce tumor immunogenicity. Essentially, you are presenting the patient with a radiated tumor antigen, and that cell is then producing an immunostimulatory molecule that essentially kicks the body into high gear by exciting and extending the T-cell response to the antigen.

BriaCell has gotten encouraging results so far, but only in 18 women, so we don't have an enormous amount of data. But, generally speaking, these women have a life expectancy of only about a year. Of the 18 patients treated with BriaVax, several have made it out to 34, 36, even 40 months, and that's impressive. The company is getting ready to conduct another Phase 2 study in 2016.

TLSR: This is an allogeneic therapeutic vaccine, and as such, it would be an off-the-shelf agent, unlike Provenge, which had to be manufactured for each patient individually. That makes BriaVax interesting from a cost-of-goods-sold perspective. Are we talking about a single antigen being presented to the patient's immune system?

JN: No. The whole tumor cell is presenting multiple antigens to the body. That is the exciting thing. BriaVax is not specific to estrogen receptor-positive or HER2-positive tumors. It is a whole cell tumor vaccine that is stimulated with GM-CSF to generate the immune response. Results have been impressive.

TLSR: There's a companion diagnostic being developed for this therapeutic immunization. The fact that the company can narrow down its patient population to a very favorable group for treatment holds potential for exciting p-values in the clinical trial, doesn't it?

JN: That's right. Personalized medicine—being able to target a patient's cancer more specifically—is an important concept and is starting to gain traction. I think personalized medicine and orphan drugs are the two biggest trends in small-cap biotech right now. The more you know about a patient and how your drugs work for that patient's disease is important not just to the patient, but also to investors. You might think that if only 50% of patients have a biomarker, the pharma company has cut the market in half. That's not true. The more specific you get, the higher price you can charge for a targeted drug. The market opportunities for personalized medicines, even in orphan indications, are tremendous. It represents a very big wave of drug development over the next several years.

TLSR: Jason, I note the company thinks BriaVax could become a maintenance therapy for the duration of the disease and possibly the patient's life. That's another interesting thought, isn't it?

JN: That idea adds to the potential size of this market. If this vaccine is found to prolong lives when used on a continuing basis, that just compounds the peak revenue potential for BriaVax. It is an exciting prospect for both patients and investors. Today this company has a market valuation of only about $20M. I think it could turn out very big. It's early-stage right now, but I really like the science. I think 2016 will prove very interesting for BriaCell if it can get its Phase 2 trial started and continue to show good data.

http://www.thelifesciencesreport.com/pub/na/let-your-biotech-winners-ride-into-orbit-jason-napodano-of-bionap-consulting
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