Her2neu Breast Cancer

TapImmune Inc. has signed an exclusive Licensing Option agreement with Mayo Clinic, Rochester, MN, for clinical development of a breast cancer vaccine technology. The option to license this technology can be exercised after Phase I clinical trials under terms agreed between Mayo Clinic and TapImmune. Mayo Clinic will conduct a Phase I clinical trial in breast cancer patients who have a form of breast cancer that express Her2/neu receptors (also called Her2/neu breast cancer). Keith Knutson, Ph.D., will serve as Principal Investigator.

Her2/neu receptor-related cancer is a very aggressive form of breast cancer that affects a subset of breast cancer patients. It is a well-established therapeutic target, which helps our development goals from a regulatory standpoint. For example, Herceptin (a Her2/neu inhibitor by Genentech) is an approved drug with annual sales in excess of $4 billion.

There are ongoing vaccine trials targeting Her2/neu. The major disadvantage of technologies that are currently in development are their inability to cover all or a majority of Her2/neu cancer patients and their ability for long-term protection. Some of them seem to be effective only in a subset of Her2/neu cancer patients due to the nature of the peptide epitopes used. Along with Mayo we believe this technology could cover up to 90% of the Her2/neu patients and last a very long time (if not a life time), which is an improvement that could cover an additional 30% of the population who may not be covered by the other technologies that are currently in development.

Glynn Wilson, Ph.D., Chairman and CEO of TapImmune, stated, “The option to license this technology from Mayo Clinic represents a significant opportunity to add to our cancer vaccine portfolio and clinical research programs. We believe that this technology offers a number of advantages in the development of a breast cancer vaccine for a broad patient population.

Ovarian Cancer

TapImmune has an exclusive license/option on a late stage phase l clinical program in ovarian cancer (Folate Receptor Alpha). We are very excited about the opportunity this therapeutic presents. Folate receptor alpha is expressed in nearly 50% of breast cancers and in addition, over 95% of ovarian cancers, for which the only treatment options are surgery and chemotherapy, leaving a very important and urgent clinical need for a new therapeutic. Time to recurrence is relatively short for this type of cancer and survival prognosis is extremely poor after recurrence. In the US alone, there are approximately 30,000 ovarian cancer patients newly diagnosed every year.

Importantly, this patient population has very few treatment options, which resulted in both Orphan Drug Status and FDA Fast Track designation for TPIV 200. Orphan drug status is allowed by the FDA in cases where the disease affects fewer than 200,000 people in the U.S., and it makes allowances for an accelerated regulatory process and sales of the drug for seven years without competition.