Elusys Therapeutics Inc. said additional funding for its ETI-204 treatment research came from the Biomedical Advanced Research and Development Authority, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
The grant totals $50 million. The company had already received $143 million under a 5-year contract.
"We are pleased that the U.S. government is continuing to support our efforts to advance ETI-204 through the final stages of our development program, including validation of our commercial manufacturing processes," said Elizabeth Posillico, president and chief executive officer of Elusys. "We recently completed a clinical dose-escalation study and look forward to reviewing those data."
The dose-escalation study involved 108 human subjects and collected additional safety and pharmacokinetic data at doses up to 16 mg/kg, administered intravenously. Elusys said two other dose escalation safety studies in humans and a number of studies assessing activity of ETI-204 against anthrax in two animal species have also been conducted.
ETI-204 was described as "a high-affinity, humanized and de-immunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to Protective Antigen."
If all activities in the ETI-204 development program are completed to the satisfaction of the U.S. Food and Drug Administration, the government could purchase ETI-204 for the Strategic National Stockpile under Project BioShield, which was established to procure countermeasures against a bio-warfare attack.
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