Date: 2015-04-22
Type of information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: Genocea Biosciences (USA - MA)
Product: GEN-004
Action
mechanism: immunotherapy product. GEN-004 is a potential universal pneumococcal vaccine designed based on insights from the Genocea’s ATLAS™ platform. GEN-004 contains three unique pneumococcal protein antigens, SP0148, SP1912, and SP2108, shown by ATLAS™ to be associated with protective TH17 T cell responses against pneumococcus in humans. All three antigens are conserved across all sequenced serotypes of pneumococcus. Instead of preventing infections caused by only a small number of serotypes of pneumococcus as vaccines currently available on the market do, GEN-004 is designed to provide protection against each of the more than 90 serotypes of pneumococcus, thereby offering potentially universal protection against pneumococcal disease. GEN-004 has been designed to generate a Th17 T cell-mediated immune response, preventing or reducing pneumococcal colonization in the nasopharynx.
Disease: prevention of infection by all serotypes of pneumococcus
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On April 22, 2015, Genocea Biosciences, a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, 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 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.
