Pefenex will supply cGMP-grade CRM197 carrier protein to The Henry M. Jackson Foundation (HJF) for the Advancement of Military Medicine to supply cGMP-grade CRM197 carrier protein. CRM197 is a nontoxic variant of diphtheria toxin and is utilized as a carrier protein in multiple approved conjugate vaccines.
The arrangement will support testing and potential development of a conjugate vaccine. In addition, Pfenex will grant HJF access to a biologics master file that will be filed with the FDA to support regulatory submissions related to the vaccine.
CRM197 has been shown to be an excellent carrier for polysaccharides and haptens and enables conversion of poorly immunogenic antigens to elicit an immunologic memory response. Pfenex has developed a recombinantly produced form and is making it available to vaccine developers at commercial scale quantities in both cGMP and reagent grades.
“Along with our recently announced contract awarded by the U.S. Department of Health and Human Services/ Biomedical Advanced Research and Development Authority, in which Pfenex will develop a next-generation anthrax vaccine, this agreement demonstrates how Pfenex is leveraging our advanced protein-expression platform to support multiple areas of vaccine research and development in both complex antigen production and the supply of key conjugate vaccine carrier proteins.”