Gil Roth12.05.13
Genocea Biosciences has initiated a Phase I study of GEN-004, an investigational vaccine candidate for pneumococcus (Streptococcus pneumoniae). GEN-004 is the first vaccine candidate designed to prevent infections caused by all strains of pneumococcus through a novel T cell-mediated mechanism of action.
GEN-004 contains three unique protein antigens, SP0148, SP1912, and SP2108, shown by Genocea’s proprietary antigen discovery platform, ATLAS, to be associated with protective TH17 T cell responses against pneumococcus in humans. In preclinical studies presented at the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in 2012, GEN-004 significantly reduced nasopharyngeal colonization by stimulating TH17 immune responses.
Each protein in GEN-004 is also conserved across all sequenced strains of pneumococcus, meaning that GEN-004 could represent a universal vaccine against pneumococcus working through a novel mechanism of action. There are more than 90 known strains of pneumococcus. Approved vaccines prevent disease caused by the most prevalent strains of pneumococcus, but do not prevent disease caused by strains not in the vaccines. Emerging evidence suggests that strains not in the existing vaccines play an increased role in causing pneumococcal disease.
The Phase I study is a randomized, double-blind, dose-escalation, placebo-controlled clinical trial enrolling approximately 90 healthy adult volunteers. The study will seek to evaluate the safety and immunogenicity of GEN-004 across a range of doses. Genocea expects initial results in 2Q14.
GEN-004 is the second clinical candidate designed with insights from Genocea’s ATLASTM antigen discovery platform, which identifies vaccine targets by profiling the T cell responses to a pathogen in large populations of humans exposed to that pathogen. Genocea’s lead program is GEN-003, a therapeutic vaccine candidate designed to treat people infected with Herpes Simplex Virus type 2 (HSV-2). Genocea recently reported positive interim Phase I/IIa data for GEN-003, including a statistically significant 51% reduction in viral shedding frequency.
GEN-004 contains three unique protein antigens, SP0148, SP1912, and SP2108, shown by Genocea’s proprietary antigen discovery platform, ATLAS, to be associated with protective TH17 T cell responses against pneumococcus in humans. In preclinical studies presented at the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in 2012, GEN-004 significantly reduced nasopharyngeal colonization by stimulating TH17 immune responses.
Each protein in GEN-004 is also conserved across all sequenced strains of pneumococcus, meaning that GEN-004 could represent a universal vaccine against pneumococcus working through a novel mechanism of action. There are more than 90 known strains of pneumococcus. Approved vaccines prevent disease caused by the most prevalent strains of pneumococcus, but do not prevent disease caused by strains not in the vaccines. Emerging evidence suggests that strains not in the existing vaccines play an increased role in causing pneumococcal disease.
The Phase I study is a randomized, double-blind, dose-escalation, placebo-controlled clinical trial enrolling approximately 90 healthy adult volunteers. The study will seek to evaluate the safety and immunogenicity of GEN-004 across a range of doses. Genocea expects initial results in 2Q14.
GEN-004 is the second clinical candidate designed with insights from Genocea’s ATLASTM antigen discovery platform, which identifies vaccine targets by profiling the T cell responses to a pathogen in large populations of humans exposed to that pathogen. Genocea’s lead program is GEN-003, a therapeutic vaccine candidate designed to treat people infected with Herpes Simplex Virus type 2 (HSV-2). Genocea recently reported positive interim Phase I/IIa data for GEN-003, including a statistically significant 51% reduction in viral shedding frequency.