Genocea is developing both therapeutic and prophylactic vaccines for HSV-2 based on the discovery and validation of antigens with our ATLAS™ platform.
Our lead candidate in HSV-2 is GEN-003, a first-in-class, protein subunit, therapeutic T cell vaccine designed to reduce the duration and severity of clinical symptoms associated with moderate-to-severe HSV-2, and to control transmission of the infection. A Phase 1/2a clinical trial is currently underway to evaluate the safety and tolerability of GEN-003. The study will also assess the vaccine's impact on viral shedding, the process by which the virus can spread between people. Read more about the ongoing clinical trial here.
Unlike previous HSV-2 vaccine candidates, GEN-003 is a protein subunit vaccine designed to mount responses from both the T and B cell arms of the immune system, which is believed to be critical to achieving long-term control of this chronic infection. GEN-003 includes the antigens ICP4 and gD2, as well as the proprietary adjuvant Matrix-M™ licensed from Isconova AB. The adjuvant is a novel, saponin-derived product that has demonstrated a balanced B and T cell immunostimulatory profile.
In preclinical proof-of-concept studies, these antigens demonstrated protection against disease, and reduced the duration and severity of clinical symptoms and viral shedding. Genocea presented data from these studies in 2012 at the American Association of Immunologists annual meeting and International Herpesvirus Workshop. More information on these data is available here.
If approved, GEN-003 will be the first therapeutic vaccine to address an infectious disease. For more information on our clinical trial, please see http://clinicaltrials.gov/ct2/results?term=gen-003.
Herpes simplex virus type 2, (HSV-2), the most common cause of genital herpes, is a sexually transmitted disease that is estimated to infect more than 500 million people worldwide and one out of six people aged 15 to 49. In the U.S. alone, an estimated 50-60 million people are affected. There is neither a cure nor a vaccine to prevent or treat HSV-2. Antivirals are currently used to treat acute outbreaks and reduce transmission risk. If approved, GEN-003 will be the first treatment providing patients with long-term management of their clinical symptoms.
HSV-2 infection can cause recurring, painful genital sores, and can be stigmatizing and produce considerable psychological distress in patients. The disease is particularly severe in immunosuppressed patients and poses significant risk to newborns if it is transmitted from mothers during birth.