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
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
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.