Genocea begins Phase IIa trial of GEN-004 to treat pneumococcus

The trial will assess the effect of dosing with GEN-004 on the frequency, magnitude and duration of colonization by pneumococcus in the nasopharynx of healthy adults.

About 90 healthy adult subjects from one site in the UK will be included in the trial and they will be randomized to placebo or GEN-004.

During the trial, GEN-004 will be dosed three times at one month intervals with 100 micrograms per protein and 350 micrograms of alum.

After completion of the third dose of GEN-004 or placebo, all subjects will be challenged with pneumococcus.

Genocea chief medical officer Seth Hetherington said after the positive Phase I data results, which they announced in June, this Phase IIa human challenge study is an important step towards demonstrating proof of concept for GEN-004.

"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," Hetherington said.

Genocea president and chief executive officer Chip said "Available pneumococcal vaccines protect by inducing B cell, or antibody, immune responses directed towards a minority of the more than 90 known serotypes of pneumococcus.

"Furthermore, serotypes not included in the available vaccines are increasingly responsible for causing pneumococcal disease."

According to the company, interim results from the Phase IIa trial are scheduled to be reported in the middle of 2015.