Genocea commences GEN-003 Phase 1/2a study in moderate-to-severe HSV-2 infection

Genocea Biosciences announced today that it has initiated a Phase 1/2a clinical study with its lead candidate, GEN-003. GEN-003 is an investigational vaccine designed to stimulate T cell and B cell immune responses to potentially reduce the frequency and severity of clinical outbreaks associated with moderate-to-severe Herpes Simplex Virus type 2 (HSV-2) infection.    

This study is a double-blind, placebo-controlled dose escalation clinical trial enrolling approximately 150 volunteers with moderate-to-severe HSV-2 infection who are otherwise healthy. The study will seek to evaluate the safety and tolerability of GEN-003 and its ability to stimulate the immune system, as well as determine the impact of the vaccine upon viral shedding, which is considered to be a marker of disease recurrence and transmission.

Unlike prior investigational vaccines for HSV-2, GEN-003 is designed as a protein subunit vaccine to induce balanced B and T cell immune responses, which may be critical for addressing infections not sufficiently controlled by the B cell, or antibody, arm of the immune system alone. The vaccine is comprised of two proteins, ICP4 and gD2, as well as Matrix M™, a proprietary adjuvant from Isconova AB.

"T cell immunity is increasingly understood as essential to providing protection against many infectious diseases," said Seth Hetherington, MD, Chief Medical Officer of Genocea Biosciences. "Our platform enables us to comprehensively evaluate potential T cell antigens with a speed not possible through traditional methods. This program provides the first opportunity to evaluate the benefit our unique approach may have for patients."

Genocea recently announced data from preclinical studies of GEN-003, which demonstrated the ability of the candidate vaccine to elicit strong and lasting B and T cell immune responses, and showed a significant impact on the severity and duration of the disease.

There is currently no preventive vaccine or cure for HSV-2, and therapeutic options are limited to daily antiviral medications or suppressive therapy. If approved, GEN-003 would be the first therapeutic vaccine for patients with HSV-2 infection.