Genocea Biosciences announced updated results for its Phase 1/2a study with GEN-003, a vaccine candidate under development for the treatment of herpes simplex virus type 2 (HSV-2) infection. GEN-003 is a first-in-class T cell vaccine candidate intended to reduce the transmission risk and clinical symptoms of HSV-2 by inducing a balanced B cell and T cell immune response which is believed to be critical to achieving a long-term control of HSV-2.
The ongoing clinical trial is a double-blind, placebo-controlled, dose-escalation study designed to evaluate the safety and immunogenicity of GEN-003 in 143 volunteers with a history of moderate-to-severe recurrent HSV-2 infection. Patients were sequentially enrolled into 1 of 3 dose cohorts (10mcg, 30mcg, or 100mcg of each protein) and randomized within cohorts to receive either GEN-003, vaccine antigens without adjuvant or placebo. Patients received three injections of the assigned treatment into an arm muscle at 21-day intervals, and are being followed for 1 year after the third injection.
Results demonstrated that patients treated with GEN-003 at the 30mcg dose level experienced a 72% reduction in lesion days six months after study initiation compared to baseline levels (P<0.001). The results expand upon the positive initial data reported previously showing that patients treated at the 30mcg dose level experienced a 50% reduction in mean viral shedding from baseline (P<0.001) immediately following three doses, which was maintained at six months (P<0.001).
GEN-003 is designed with insights from Genocea’s ATLAS antigen discovery platform, which identifies vaccine targets by profiling the T cell responses to a pathogen in large populations of humans exposed to that pathogen. GEN-003 includes fragments of ICP4 and gD2 antigens, as well as the proprietary adjuvant, Matrix-M, licensed from Novavax, Inc. The adjuvant is a novel saponin-derived product that has demonstrated a B and T cell immunostimulatory profile in previous clinical studies.
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