Genocea Reports Positive 6-Month Results From GEN-003 Phase 2b Trial

(RTTNews) - Genocea Biosciences Inc. (GNCA) announced positive clinical results from a planned interim analysis of its ongoing placebo-controlled Phase 2b trial evaluating GEN-003 for the treatment of genital herpes infections. Even in a trial this small, at six months after dosing, GEN-003 demonstrated statistically significant improvements versus placebo across multiple clinical endpoints.

The 60 µg per antigen / 50 µg of adjuvant dose of GEN-003 significantly reduced the rate of genital lesions during the six months following dosing compared to placebo (4.5 percent of days vs. 7.9 percent, respectively; 41% reduction vs. placebo, p<0.05). The genital lesion rate is an important overall measure of disease that captures both the frequency and duration of recurrences, both of which are important to both patients and their caregivers. In the trial, GEN-003 also consistently demonstrated significant benefits versus placebo across several other clinical endpoints across the dose groups.

In aggregate, the data from the GEN-003 Phase 2 clinical trials continue to support the selection of the 60 µg per antigen / 50 µg of adjuvant dose for the planned Phase 3 program. GEN-003 also continues to demonstrate a safety profile appropriate for its therapeutic setting in the judgment of the trial's independent Drug Monitoring Committee.

"We look forward to meeting with the FDA in the first quarter of 2017 and to commencing our GEN-003 Phase 3 program in the fourth quarter of 2017. It's an exciting time for Genocea as we also continue to extend the potential of our ATLAS platform to harness the power of T cells in immuno-oncology," said Chip Clark, president and chief executive officer of Genocea.