My family, like many others, has been impacted by breast cancer. We got off lucky and still have our loved one around, but many others haven’t been as fortunate.
TapImmune, Inc. (OTC: TPIV) is attempting to do exactly that. The firm is developing a treatment to greatly reduce the mortality rate of breast cancer -- a disease with existing medicines that generate billions in revenue each year but only treat 20% of the afflicted population.
I want to state upfront: TPIV is not an investment for widows or orphans. With analyst targets that are, in some instances, seven times the current share price, this opportunity might merit a small position in a diversified portfolio.
TapImmune is trying to open a new frontier in immunotherapy, or the prevention and treatment of disease with substances that stimulate the body’s immune response.
What that means is that instead of trying to kill cancer cells with an outside agent, immunotherapy uses materials that improve, target and restore the patient's immune system to help slow the cancer's growth, stop its spread and kill the cancerous cells.
This is where TapImmune’s approach is different. It works on priming the function of both sides of the cancer killing equation:
-- Enhance killer T-cell and T-helper cell function
-- Restore antigens in tumor cells, allowing the immune system to recognize and attack them
There are currently treatments available that attempt to do one, but not both of those things. TapImmune's approach enables the drug to treat a wider patient population than current therapies.
The specific form of breast cancer that TapImmune is initially targeting is called HER2/neu, which is one of the most aggressive forms of the disease. It impacts 220,000 people every year.
The current standard treatment for this disease is Roche’s Herceptin, which can only treat 20% of those diagnosed with this type of breast cancer. And despite only being able to treat a fifth of the possible patients, Herceptin rang up $6 billion in 2013 sales.
TapImmune believes that its treatment may help up to 84% of those afflicted, which could equate to sales of more than $20 billion. This, of course, is an ideal scenario, which would require many factors going right for TapImmune over the long term.
The company is focused on developing four product candidates, two of which are currently finishing phase I studies. The other two product candidates are proprietary immunotherapeutic technologies that are in preclinical trials.
TapImmune signed an exclusive licensing option agreement with the Mayo Clinic in 2010.
In July 2011, The FDA approved a phase I human clinical trial in involving 22 patients previously treated with Herceptin, but would now be given the TapImmune vaccine.
Initial analysis on the first six patients was promising -- proving the vaccine's safety in humans and showing specific T-cell immune responses to antigens among the patients.
More information from the trial is expected by year end and could prove to be a major catalyst for the company.
Risks to consider: By nature a biotech company like TapImmune is very risky in nature. I can’t stress enough that an investment in companies like this need to be small. When the upside is this big you can generate a big win without risking a lot of capital.
I would also caution that the biotech sector in general has had a very good run. It is quite possible that waiting for a sector downturn, which could come fairly soon, might present a better entry point.
Action to take --> Take a very small position in TapImmune for exposure to its potentially revolutionary cancer treatment. When the potential rewards are this large, even a small position can turn into a large sum of money.