Elusys validates manufacturing process for anthrax antitoxin

Elusys Therapeutics, Inc., a biopharmaceutical company developing antibody therapies for infectious diseases, announced on Tuesday that it completed validation of the commercial manufacturing process for ETI-204, an anthrax antitoxin.

ETI-204 is now undergoing Phase III clinical trials in healthy volunteers and is a potential target for future acquisition into the U.S. government's Strategic National Stockpile. The candidate is the only anthrax antitoxin in the advanced stages of development that is being investigated for intramuscular and intravenous prophylaxis administration.

The ability to administer an antitoxin via intramuscular injection would serve as an alternative to intravenous injection in an emergency where medical personnel and resources are limited.

"We have completed all the planned validation activities for our commercial manufacturing process, and are now finalizing the supporting documentation to file for licensure," James Porter, the vice president of development and manufacturing at Elusys, said. "Completing the manufacturing validation work is an important milestone along the path to (biologic license application) licensure and confirms our ability to supply commercial quantities of ETI-204 to the Strategic National Stockpile."

ETI-204 is a high-affinity, humanized and deimmunized monoclonal antibody targeting the protective antigen of anthrax-causing Bacillus anthracis. The antitoxin neutralizes the lethal effects of anthrax toxins by binding to the protective antigen. ETI-204 was granted orphan drug designation and fast track status by the U.S. Food and Drug Administration.