Genocea Completes Enrollment in Phase 2a Human Challenge Study of GEN-004 for the Prevention of Infection by Pneumococcus

Genocea Biosciences, Inc.

, a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today reported that it has completed enrollment in its Phase 2a human challenge study of GEN-004, Genocea's universal vaccine candidate for the prevention of infection by all serotypes of pneumococcus. The Company anticipates reporting top-line data from this study in the fourth quarter of 2015. "The objective of this trial is to demonstrate proof of concept that GEN-004 can reduce the frequency, magnitude or duration of colonization of pneumococcus in the nasopharynx of healthy adults," said Seth Hetherington, M.D., Chief Medical Officer of Genocea. "Colonization in the nasopharynx is a necessary precursor to infection by pneumococcus and success in this trial will provide further evidence of the potential of GEN-004 to control colonization and strongly position us to advance GEN-004 into further efficacy studies in 2016." The Phase 2a trial enrolled 98 healthy adult subjects at one site in the United Kingdom. Subjects are randomized to receive 3 doses of either placebo or GEN-004 at 100 micrograms per protein and 350 micrograms of alum adjuvant. All subjects are challenged with pneumococcus after the third dose of the assigned treatment and subsequently tested for the establishment of colonization. The current study follows positive Phase 1 results, demonstrating that GEN-004 met its safety, tolerability and immunogenicity goals, including increases in blood T helper 17 (TH17) cells, a rare cell type that provides important protective immunity at epithelial and mucosal surfaces. For more information about this Phase 2a clinical study of GEN-004 visit www.clinicaltrials.gov.