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Genocea Reports Positive Initial Phase 1/2a Results for GEN-003, its Pioneering Therapeutic Vaccine Candidate for the Treatment of Herpes Simplex Virus-2 (HSV-2), at ICAAC 2013
Date:9/12/2013

ory Medicine, University of Washington, Member, Fred Hutchinson Cancer Research Center. "The ability to reduce viral shedding is critical, as that is the main driver of transmission of HSV-2 to sexual partners and newborns."

"These initial results are unprecedented in the clinical development of vaccines for HSV-2. We are proud to be pioneers in the field of T cell-directed vaccines. We believe these results validate the potential of our unique ATLAS™ platform to discover and develop vaccines for unmet medical needs," noted Chip Clark, President and Chief Executive Officer of Genocea. "We will complete this study and continue clinical development of GEN-003 with urgency, in order to bring this promising treatment to this large patient population that is in dire need of an approved vaccine that can prevent or treat their disease."

About the Clinical Trial  
The ongoing study is a double-blind, placebo-controlled dose escalation Phase 1/2a clinical trial to evaluate the safety and immunogenicity of GEN-003. The study enrolled 143 volunteers with a history of moderate-to-severe recurrent HSV-2 infection at seven clinics in the U.S. Patients were sequentially enrolled into one of three dose cohorts (10, 30 or 100 ug of each protein) and randomized within cohorts to receive either GEN-003, vaccine antigens without adjuvant or placebo. Patients received three injections of the assigned treatment into an arm muscle at 21 day intervals. Antibody (B cell) and T cell immune responses to the two protein antigens contained in the vaccine were measured. Safety was monitored by an independent Data Safety Monitoring Committee. A secondary objective of the study was to compare the quantitative presence of HSV-2 ("shedding") before and after the treatments. Viral shedding is considered an important marker for risk of recurrence and transmission of infection.  For more information about this clinical study of GEN-
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SOURCE Genocea Biosciences Inc.
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