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Genocea Announces Top-Line Results from Phase 2a Trial for Universal Pneumococcal Vaccine Candidate GEN-004


Genocea Biosciences, Inc. (GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced that top-line results from a Phase 2a clinical trial for GEN-004, its universal vaccine candidate against pneumococcus, showed consistent reductions versus placebo in the pre-specified endpoints of the rate and density of colonization, but that neither of the endpoints achieved statistical significance. GEN-004 was safe and well tolerated by subjects.

“We are currently working with our advisors to better understand these results and to determine a 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. At this time, we believe it is possible that future trials would require a change in some combination of dose, adjuvant or trial population to confirm any effect,” said Chip Clark, president and chief executive officer of Genocea. “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.”

The Phase 2a human challenge study was a randomized, double-blind, placebo-controlled study of 98 healthy adults. Subjects were randomized in a 1:1 ratio to receive GEN-004 or placebo. Subjects received three doses at four-week intervals. Following the third dose, participants were inoculated intra-nasally with pneumococcus serotype 6B. Nasal washes were performed at two, seven and 14 days post inoculation.

GEN-004 reduced the colonization rate, measured by microbiological culture, by between 22 and 25 percent versus placebo across those measurement time points. When measured by the presence of pneumococcal DNA, the reductions ranged between 18 and 36 percent. Additionally the median density of colonization measured by microbiological culture for GEN-004 treated subjects ranged from zero to 2 colony forming units (“CFUs”) per mL of nasal wash compared to one to 11 CFUs per mL for the placebo group. When measured by the presence of pneumococcal DNA, the median densities ranged from zero to 10 copies per mL in treated subjects and 19 to 52 copies per mL in placebo subjects. None of the differences were statistically significant...