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Genocea Bio's T cell vaccine candidate flunks mid-stage trial; shares down 30% premarket

Oct. 19, 2015 8:36 AM ETGenocea Biosciences, Inc. (GNCAQ) StockBy: Douglas W. House, SA News Editor3 Comments
  • Thinly traded micro cap Genocea Biosciences (OTC:GNCA) slumps 30% premarket on robust volume in response to its announcement that its universal pneumococcal vaccine candidate, GEN-004, failed to significantly beat placebo in a Phase 2a study. The clinical trial was a randomized, double-blind, placebo-controlled human challenge study in 98 healthy adult volunteers. Subjects were randomized 1:1 to receive three doses of GEN-004 or placebo at four-week intervals. Following the third dose, participants were inoculated intranasally with pneumococcus serotype 6B. Nasal washes were performed at two, seven and 14 days post inoculation.
  • GEN-004 reduced the colonization rate, measured by culture, by 22 - 25% versus placebo across the time points while the reduction in pneumococcal DNA was 18 - 36% compared to placebo. The differences were not statistically significant. There was no difference in the duration of colonization between GEN-004 and placebo.
  • CEO Chip Clark says, "We are currently working with our advisors to better understand these results and to determine the next step for this program. While we did not hit statistical significance in this study, the consistent apparent effect gives us confidence in the vaccine concept and in the potential for GEN-004. For the time being, we are removing the development of GEN-004 from our near-term plans to focus our resources on the ongoing Phase 2 program for GEN-003, our immunotherapy for genital herpes, for which we recently announced positive six-month efficacy results, and on maximizing the potential of our preclinical pipeline and our ATLAS technology for T cell target discovery."

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