Florida Biotech Company Licenses Cancer-Fighting Therapy From Mayo
This year is likely to be an important one for the Mayo Clinic’s efforts to develop vaccines countering breast and ovarian cancers: A biotech company that has licensed two promising immunotherapies from the clinic says it’s gearing up for crucial 2016 phase II clinical studies for each of them.
TapImmune Inc. (OTC: TPIV) of Jacksonville, Florida revealed in a recent presentation to investors it’s ready to proceed this year on second-stage clinical studies for its TPIV 200 and TPIV 100/110 anti-cancer vaccines, both based on research licensed from the Mayo Clinic.
They are being targeted for the fast-growing immuno-oncology sector. The company touts 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 the immunotherapy 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.
First in TapImmune’s pipeline is TPIV 200, which received a $13.3 million U.S. Defense Department grant last year to fund a large-scale Phase II study that is to get underway shortly. It’s being led by Keith Knutson, a Mayo professor of immunology, and Dr. Edith Perez, deputy director at large for the Mayo Clinic Cancer Center. Both are based at the clinic’s Florida campus in Jacksonville.
TPIV 200 is a vaccine aimed at “triple-negative” breast cancer, ovarian cancer and non-small cell lung cancer. It is comprised of custom T-cell antigens developed by Mayo that seek out a protein known as Folate receptor alpha – a substance that is hidden from the body’s immune system in normal tissue but is overexpressed in malignant cells, thus making it an attractive target for cancer immunotherapy.
Folate receptor alpha is overexpressed in more than 90 percent of ovarian cancer cells, more than 80 percent of triple-negative breast cancer cells and 80 percent of non-small cell lung cancer cells.
In the United States, approximately 30,000 ovarian cancer and 40,000 triple-negative breast cancer patients are newly diagnosed every year. Their only treatment options now are surgery, radiation and chemotherapy. Meanwhile, the time to recurrence is relatively short for these cancers and survival prognoses are extremely poor after recurrences.
The TPIV 200 Phase I trial concluded last year found positive immune responses in 20 of 21 evaluable patients, while 16 out of 16 evaluable patients showed T-cell responses lasting long enough to be observable. The upcoming Phase II trial will involve 280 patients with triple-negative breast cancer.
TapImmune obtained the license for the Folate receptor alpha technology from the Mayo Foundation last year for an initial upfront payment of $350,000, SEC filings indicate. In addition to the initial fee, the company is to make additional upfront payments, an annual license maintenance fee, milestone fees and royalty fees to Mayo as the product is commercialized. It received FDA “fast track” designation for ovarian cancer in February.
The second promising collaboration between the two is a similar T-cell antigen technology dubbed TPIV 100/110, which is being developed for patients who have a particularly aggressive form of breast cancer known as HER2/neu. It is so-called because the malignant cells express a protein called human epidermal growth factor receptor 2 on their surfaces; about 20 percent of all breast cancers are HER2-positive.
TapImmune Strategic Advisor Dr. John Bonfiglio told attendees at the 28th annual Roth Capital Partners Conference in California last month that after encouraging results in the Phase I trial — also conducted by Mayo’s Keith Knutson — the company will seek to file an Investigational New Drug application with the FDA later this year, to be followed by a Phase II trial.
TapImmune licensed the HER2/neu antigen technology from Mayo in 2012 for upfront fees of $250,000 plus milestone fees and royalties on future gross annual sales.
In its 2015 annual report, the pre-revenue company asserts that if its therapy successfully reaches commercialization, it would be applicable to 50 percent of the HER2/neu breast cancer market, which it estimates at $21 billion annually.
TapImmune is traded over-the-counter as a penny stock, reaching a 52-week high price of $1.71 last June when it reported positive results from the HER2/neu trial. Its chairman and CEO is drug development veteran Glynn Wilson, while its biggest investor is Eastern Capital Limited, a hedge fund indirectly owned by Kenneth Dart, former president of Dart Container Corp.