Goals: establish GEN-003 proof of concept and initial dose exploration
Endpoints: reduction in viral shedding and genital lesions
Results: GEN-003 demonstrated durable reductions in both lesion and viral shedding rates vs. baseline, with the 30 µg per protein / 50 µg of adjuvant showing the best results; GEN-003 elicited a broad range of immune responses, durable to at least 12 months; GEN-003 was well tolerated.
Phase 2 Trial Summary:
Goal: optimize dose of GEN-003 by exploring different combinations of protein and adjuvant
Endpoints: reduction in viral shedding and genital lesion rates, time to first outbreak, percent reduction free at 6 and 12 months
Results: GEN-003 demonstrated improved and sustained impact on viral activity, showing potential for durable efficacy longer than 12 months; 60 µg per protein paired with either 50 µg or 75 µg of adjuvant performed best; clinical efficacy demonstrated across potential Phase 3 endpoints; data indicate GEN-003 stimulates a multi-faceted T cell immune response to genital herpes and strong antibody response; GEN-003 well tolerated.
Ongoing Phase 2b Trial:
Goal: final selection of GEN-003 dose using new Phase 3-ready formulation
Endpoints: reduction in viral shedding, genital lesion rates, time to first outbreak, time to next outbreak, percent reduction free at 6 and 12 months, total number of outbreaks
Results: 6-month data results demonstrate statistically significant improvements versus placebo across multiple clinical endpoints; significant reduction in viral shedding immediately post dosing; 60/50 dose confirmed for Phase 3 clinical program.
Results to Come: 6-month viral shedding data and 12-month clinical results expected in 2017