July 21, 2014
Genocea Biosciences, Inc., a clinical-stage biopharmaceutical company developing T cell-enabled vaccines and immunotherapies, today announced the start of a Phase 2 dose optimization trial for GEN-003, the Company’s immunotherapy candidate against herpes simplex-type 2 (HSV-2).
“Consistent with our long-standing development plans, this Phase 2 trial will compare the best dose of GEN-003 from our Phase 1/2a trial to other combinations of protein and adjuvant to determine the optimal dose for future trials and potentially improve on the current profile of GEN-003,” said Seth Hetherington, MD, chief medical officer of Genocea. “This Phase 2 trial builds on our successful Phase 1/2a clinical trial, which we believe was the first time that a therapeutic vaccine has shown an anti-viral effect.”
The Phase 2 dose optimization study will enroll approximately 300 subjects from 17 institutions in the United States and will study six combinations of two antigen doses (30 micrograms or 60 micrograms) with each of three adjuvant doses (25 micrograms, 50 micrograms, or 75 micrograms) alongside a placebo. All subjects will receive three doses of GEN-003 or placebo at 21-day intervals. The primary end point for the study is the change from baseline in viral shedding rate. The study is also designed to evaluate the impact on percentage of days with genital herpes lesions as reported by patients. Subjects receiving GEN-003 will be followed for 12 months after the last dose. Previously the Company announced results from its Phase 1/2a clinical trial of GEN-003, which demonstrated, in the 30 microgram dose group, statistically significant reductions from baseline in viral shedding and genital lesion rates of up to 52% and 65% respectively, with a durability of effect to six months after dosing.
“We believe that there is a significant clinical need for an effective immunotherapy to treat HSV-2. Our market research supports that both patients and physicians would welcome a new treatment, such as GEN-003, with efficacy similar to oral antivirals, sustained duration of protection and enhanced convenience through simplified dosing,” said Chip Clark, president and chief executive officer of Genocea. “We look forward to announcing interim results from this trial in the middle of 2015.”
For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.
GEN-003 is Genocea’s lead product candidate and is a T cell-enabled immunotherapy intended to reduce the transmission risk and clinical symptoms of HSV-2. GEN-003 was designed with insights from Genocea’s ATLAS™ platform which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, enabling the identification of antigen targets which drive protective T cell responses with which to design potential new vaccines and immunotherapies.
For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-hsv-2/.
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. In the United States roughly 15 percent of the adult population, or 40 million people, are infected. 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. While antiviral drugs are used widely to treat HSV-2, there is neither a cure nor a vaccine for this disease.
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Using ATLAS™, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003, in development for HSV-2 therapy; GEN-004, in development to prevent infections caused by pneumococcus; and earlier-stage programs in chlamydia, HSV-2 prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company’s website at www.genocea.com.