Pneumococcal Vaccine Snags Breakthrough Therapy Designation

A mid-stage clinical study of an experimental vaccine for Streptococcus pneumoniae is showing promise. Phase II data shows the vaccine candidate developed by Affinivax and Astellas Pharma is well tolerated and generated an antibody response against the deadly bacterial infection.

The Phase II data showed that the vaccine candidate ASP3772 generated an antibody response to each of the 24 polysaccharides in its makeup and antibody response to the two conserved pneumococcal proteins also included in its makeup. The 24 serotypes included in the vaccine candidate are more than any other vaccine on the market or clinical testing today.

ASP3772 was developed using Affinivax’s proprietary MAPS (Multiple Antigen-Presenting System) technology in order to generate B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. 

Coinciding with the positive Phase II data, both companies announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to the vaccine candidate. The designation is based on the Phase II data. 

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