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news.US-based Biomedical Advanced Research and Development Authority (BARDA) has granted $50.2m to Elusys Therapeutics for the development of investigational ETI-204 (Anthim) agent, designed for the treatment of inhalational anthrax following a biowarfare attack.
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ETI-204 is a humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins.
Under the grant, Department of Health and Human Services will conduct definitive efficacy studies in animals and complete validation of the commercial manufacturing process for ETI-204.
Elusys president and chief executive officer Elizabeth Posillico said the company is pleased that the US Government is continuing to support its efforts to advance ETI-204 through the final stages of development program, including validation of commercial manufacturing processes.
"We recently completed a clinical dose-escalation study and look forward to reviewing those data," Posillico added.
The company said, the federal government will purchase ETI-204 for the strategic national stockpile (SNS) under Project BioShield, if all activities in the ETI-204 development program are completed according to FDA’s satisfaction.