Updated Phase 1/2a results with GEN-003, a vaccine candidate under development by Genocea Biosciences, Inc. (Nasdaq: GNCA) for the treatment of herpes simplex virus type 2 (HSV-2) infection, showed the experimental vaccine to generate highly significant reductions in both the number of clinical lesion days and rate of viral shedding at six months after the final vaccine dose. Genocea, a company pioneering novel T cell vaccines and immunotherapies, reported the results from the ongoing trial of GEN-003 today as an oral presentation at the World Vaccine Congress, being held March 24-26 in Washington, DC.
The ongoing Phase 1/2a double-blind, placebo-controlled study showed that patients treated with GEN-003 at the 30 microgram dose level experienced a 72 percent 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 as a late breaker at ICAAC in September 2013 showing that patients treated at the 30 microgram dose level experienced a 50 percent reduction in mean viral shedding from baseline (p<0.001) immediately following three doses, which was maintained at six months (p<0.001). Treatment with GEN-003 was well tolerated overall.
"HSV-2 is an incurable sexually transmitted disease that affects over 500 million people worldwide, and current oral drugs require costly, inconvenient daily dosing to optimally control the painful symptoms of HSV-2 outbreak or to block viral transmission to other individuals," said Jessica Baker Flechtner, PhD, Genocea senior vice president of research, who presented the data. "This is the first time an HSV-2 immunotherapy has shown a significant impact on clinical symptoms, and the fact that GEN-003 has shown durable results six months after study initiation is very encouraging. Results of this initial clinical study of GEN-003, if confirmed by further clinical testing, suggest a compelling best-in-class profile for this therapeutic vaccine against HSV-2 infection, that may lead to reductions in both disease transmission and recurrent disease outbreaks."
"These exciting results support the ability of GEN-003 to provide a durable reduction in clinical symptoms, and validate the ATLAS- platform as a tool for the rational discovery and development of novel vaccines and immunotherapies," said Chip Clark, president and chief executive officer of Genocea. "We expect to announce twelve-month data from this study in mid-2014, and also plan to initiate additional Phase 2 testing of GEN-003 in 2014 to further optimize dosing."