The huge sales generated by Prevnar 13 mean Pfizer ($PFE) appears to have the pneumococcal vaccine sector sewn up, but Genocea Biosciences sees an opportunity to disrupt the monopoly. This week, the Cambridge, MA-based biotech began a Phase I clinical trial of the vaccine it thinks can unseat Prevnar.
Genocea developed the vaccine, currently called GEN-004, using the antigen discovery technology that spawned its lead candidate, herpes simplex vaccine GEN-003. It is this approach that gives Genocea the chutzpah to take on Pfizer's blockbuster. While the latest version of Prevnar protects against 13 strains of pneumococcus, Genocea is aiming to confer immunity against all forms of the bacteria. Prevnar 7 and 13 have had a huge effect on disease, but the 80 strains not covered by the vaccines are still causing some cases.
A paper published in PLOS ONE in September found that the introduction of Prevnar 7 coincided with a rise in cases of invasive pneumococcal disease caused by the 80 strains not covered by the vaccine. Pfizer subsequently expanded protection by introducing Prevnar 13, but Genocea thinks there is still a need for a more comprehensive vaccine that will stop the impact of strain replacement. "In a way, Prevnar is a victim of its own success," Genocea CEO Chip Clark told FierceVaccines.
Genocea, a 2008 FierceBiotech Fierce 15 company, has heavy hitters in its corner. George Siber, who was chief scientific officer at Wyeth when Prevnar 7 was in development, sits on Genocea's board of directors. Siber sees potential in using a T cell-directed approach to create a universal pneumococcal vaccine that will combat the bacteria in the nasopharynx, the part of the body where it may evolve. The theory is now being put to the test in a Phase I trial of 90 healthy volunteers. Data is due to be presented in the second quarter of 2014.
- here's the press release
- check out Boston Business Journal's take
Special Report: FierceBiotech's 2008 Fierce 15 - Genocea Biosciences