Genocea Presents Complete Phase 1/2a Data For HSV-2 Immunotherapy - Quick Facts

(RTTNews) - Genocea Biosciences, Inc. (GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies against serious infectious diseases, announced the presentation of final data from the Phase 1/2a study of GEN-003, the company's immunotherapy candidate for treatment of genital herpes.

The Phase 1/2a trial was a double-blind, placebo-controlled, dose-escalation study to evaluate the safety and immunogenicity of GEN-003. Further, the study was designed to demonstrate proof-of-concept that GEN-003 can reduce HSV-2 viral shedding, a measure of viral activity, and the genital lesion rate, the percentage of days during which the subjects experienced visible herpes outbreaks or lesions. Current HSV-2 therapies only partially control clinical symptoms and viral shedding, that drives disease transmission.

During a 28-day observation period 6 months after GEN-003 dosing, subjects who received 30 microgram doses of GEN-003 had a 65% reduction in genital lesion rates compared to baseline. Also, during the period, those subjects experienced a 40% reduction in viral shedding compared to baseline. Twelve months post the final dose, the mean reduction in the genital lesion rate was 42 percent below baseline for this dose group, the company said.

The study also revealed that GEN-003 was safe in all three cohorts, with the most common side effects of fatigue, muscle aches, tenderness and pain, with the majority being mild or moderate in intensity.