TapImmune, an immunotherapy company, has reported the completion of data analysis from all 21 evaluable patients treated in a phase I clinical trial. In addition, the recent financing provides immediate, short term and long term access to the capital required to execute its exclusive option to license these very promising peptides and to progress its on-going clinical program into phase II trials.
In the phase I trial conducted at Mayo Clinic, results indicate safety and positive immune response data in Folate Receptor Alpha Vaccine for ovarian and breast cancers. Eight women with HER2-negative breast cancer, 13 with ovarian cancer and one with fallopian tube cancer were enrolled. The data shows that the vaccine containing antigens to the Folate Receptor Alpha protein was very well-tolerated and safe. Increased specific T-cell immune responses against a set of 5 naturally processed Folate Receptor Alpha Class II antigenic epitopes were detected in 21 of 21 evaluable patients.
This data confirms that the peptide vaccine stimulated a cellular immune response as mechanistically predicted. The combined safety (primary endpoint) and immune response data show that the trials have been successful and provide the catalyst for progression into phase II clinical trials.
Folate receptor alpha is over-expressed in 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.
Antigens to the folate receptor alpha also are over-expressed on triple-negative breast cancer cells, which comprise approximately 15-20% of all breast cancer patients. As there are approximately 40,000 new diagnoses a year and many hundreds of thousands of untreated patients at high risk of recurrence this represents an additional multi-billion dollar market potential. These indications and lack of available therapeutics make these drugs ideal candidates for Fast Track and Orphan Drug designation from the FDA and the company will be making those applications along with its phase II FDA filings.
The company will provide an update on selection of phase II indications over the next few weeks. TapImmune recently announced a collaboration with the Vaccine & Gene Therapy Institute of Florida (VGTI Florida) to advance the current programs into phase II clinical trials in both ovarian and breast cancers (triple negative and Her2 positive). VGTI Florida is working with TapImmune on the design of clinical protocols, selection of clinical trial sites, recruitment of key opinion leaders as clinical advisors, and selection of external manufacturing and clinical resources.