Pfenex Inc., a clinical-stage biopharmaceutical company, has signed a five-year, cost plus fixed-fee contract valued at up to $143.5 million with the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services (HHS), for the advanced development of Px563L, a mutant recombinant protective antigen anthrax vaccine.

Under the contract, the base period will fund activities related to cGMP manufacturing of the drug product and a Phase Ia clinical study. Milestone-based option periods include completion of a Phase Ib clinical study, a Phase II clinical study, and non-clinical efficacy studies as well as manufacturing technology transfer and optimization, process and analytical method validation and consistency lot manufacture. Pfenex believes the successful completion of the activities under this contract could lead to a procurement contract for supply of Px563L to the Strategic National Stockpile.

The project has been funded in whole or in part with federal funds from the HHS, Office of the Assistant Secretary for Preparedness and Response, and BARDA.

Pfenex Inc. is a clinical-stage biologics company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. The company’s lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex uses its PfÄ“nex Expression Technology platform to build a pipeline of product candidates including biosimilars, vaccines, generics, and other biologics.

Source: Pfenex