Genocea Kicks Off Phase 2 Trial For Pneumococcus Vaccine
Clinical stage biopharmaceutical firm Genocea announced that it has started the Phase 2A trial for GEN-004, its universal vaccine candidate against pneumococcus.
GEN-004 contains the three pneumococcal protein antigens SP0148, SP1912, and SP2108. These antigens were determined by the company’s ATLAS platform to be related to protective immune cell responses against pneumococcus in humans. Genocea just presented positive data from GEN-004’s Phase I trial at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held in Washington, DC this month.
The company decided to launch the Phase 2A trial based on positive results from its Phase I study, showing that the vaccine met immunogenicity, safety, and tolerability endpoints. These endpoints included increase of T helper 17 (TH17) cells in the blood of patients who received the vaccine. TH17 is a rare type of cell that provides immunity at epithelial and mucosal surfaces. By activating a TH17 T cell-mediated immune response, vaccination with GEN-004 may help prevent or cut down pneumococcus colonization in the patient’s asopharynx, known to precede infection caused by all pneumococcus serotypes.
The Phase 2A trial will enroll around 90 healthy adults in the U.K. The subjects will randomly receive either placebo or GEN-004, with those in the GEN-004 arm receiving three doses of inoculations at one month intervals. All subjects will then be challenged with pneumococcus after the third dose. Seth Hetherington, MD, CMO of Genocea, explains, “The objective of this study is to demonstrate that GEN-004 can prevent or reduce colonization of the nasopharynx, the first and necessary precursor to establishment of infection.”
Pneumococcus (Streptococcus pneumoniae) kills an estimated 1.6 million people including 800,000 children around the world according to the World Health Organization (WHO). Once it has migrated from the nasopharynx into the upper and lower respiratory system, pneumococcus causes non-invasive pneumococcal disease (NIPD). This can lead to a range of diseases such as otitis media (ear infection) and non-bacteremic pneumonia. Once it has entered the bloodstream, it can cause invasive pneumococcal disease (IPD) and serious illnesses, such as sepsis and meningitis.
Existing vaccines only target a minority of the over 90 serotypes of pneumococcus and are unable to protect against serotypes not included in available vaccines. Chip Clark, president and CEO of Genocea, said, “We have a novel T cell directed approach for the development of a universal vaccine and look forward to announcing interim results from this trial in the middle of 2015.”