A breast cancer vaccine therapy researched by the Mayo Clinic is getting closer to commercialization, and with its advances, the clinic has solidified a potentially lucrative licensing deal with biotech firm TapImmune Inc. (OTC: TPIV).
 
TapImmune, which recently relocated to Jacksonsville, Florida to be near Mayo’s researchers there, confirmed its plans last week to enter Phase II clinical trials with its TPIV 100/110 immunotherapy platform, and so has exercised an option it held for a worldwide license on the Mayo know-how behind the product.
 
Mayo got an upfront payment of $300,000 as part of the June 3 transaction, according to SEC filings, but more importantly solidified its royalty position for what TapImmune touts as the world’s leading immunotherapy vaccine candidate for patients who have a particularly aggressive form of breast cancer known as HER2/neu.
 
Industry analysts and investors have become increasingly enthusiastic about immunotherapy as an emerging new paradigm in cancer treatment, with a worldwide market projected at $13 billion within seven years.
 
While there are several different fronts in that market, the Mayo/TapImmune efforts are concentrated in an area in which there are currently no approved products: vaccines that stimulate the production of the body’s cancer-killing T-cells in response to tumors. Backers believe this kind of “active immunotherapy” has the potential of not only attacking existing malignancies but also of providing long-lasting protection against recurrences.
 
TapImmune has several ongoing products, including another vaccine based on Mayo research aimed at “triple-negative” breast cancer, ovarian cancer and non-small cell lung cancer. Like the TPIV 100/110 product, it uses lab-developed antigens to seek out certain proteins that are overexpressed in cancer cells but normally hidden from the body’s natural immune system. Once unmasked by the vaccine, a “robust” T-cell immune response to the tumor can be stimulated.
 
The antigens for both products were co-developed by Keith Knutson, a Mayo professor of immunology based at the clinic’s Jacksonville campus.
 
In exercising a licensing option it has held since 2012, TapImmune signaled its optimism that Phase II human clinical trials on HER2/neu breast cancer patients will yield results similar to the Phase I trials – a finding that the therapy was “safe, well-tolerated, and provided a robust immune response across a broad patient population.”
 
Company CEO Dr. Glynn Wilson said in a statement that the licensing deal “confirms our intent to further develop and commercialize TPIV 100 and TPIV 110, our novel HER2neu vaccine technology,” and that next step is to “complete development of a Phase II vaccine formulation and to establish clinical protocols for Phase II studies,” which is now expected to be launched early in 2017.
 
TapImmune shares are a thinly-traded penny stock selling last week in the range of 50 cents, with a market capitalization of $39.6 million. The company’s biggest shareholder at 49.9 percent is Eastern Capital Limited, a hedge fund indirectly owned by Cayman Islands billionaire Kenneth Dart, former president of Dart Container Corp.
 
Dart invested $1 million in TapImmune last year, receiving a five-year warrant that, if exercised, would provide a further $7.5 million in funding. He also received callable warrants that, under certain market conditions, would provide an additional $7 million in capital to TapImmune. 
 
Additional warrants, exercisable only after the callable warrants are exercised or called, could provide the company with a further $10 million in funding.