Lonza will conduct process scale-up, technology transfer, validation, and commercial manufacturing for Anthim.
Elusys Therapeutics and Lonza inked a deal for the scale-up and commercial production of Anthim, a mAb in late-stage development for the treatment of inhaled anthrax. Lonza will provide process scale-up, technology transfer, validation, and commercial manufacturing.
The manufacturing process for Anthim was optimized for full-scale production by Lonza under a separate agreement announced in 2009. It uses Lonza’s GS Gene Expression System.
Also in 2009, Elusys was awarded a contract totaling up to $143 million from the Biomedical Advanced Research and Development Authority (BARDA) within the HHS to complete the final development, commercial manufacturing, and licensure of Anthim. The company reports that it has received grants and contracts totaling up to $177 million in government funding to date.
Based on testing that included multiple models of anthrax infection, Anthim has demonstrated potential as an effective, single-dose therapeutic for people infected by or exposed to anthrax spores. Results showed that Anthim prevented death in 70–100% of animals treated with a single dose of drug, according to Elusys.
Anthim is a high-affinity, humanized, and deimmunized mAb that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins. It is being developed for prevention and treatment of inhaled anthrax following a biowarfare attack.