Elusys Therapeutics, Inc. has completed validation of the commercial manufacturing process for ETI-204, an anthrax antitoxin currently in Phase III trials in healthy volunteers. ETI-204 is one of the only anthrax anti-toxins in late sage stage development that’s being investigated for both intravenous treatment and intramuscular prophylaxis administration. ETI-204 is a potential candidate for future acquisition into the U.S. Strategic National Stockpile for biowarfare preparedness.
"We have completed all the planned validation activities for our commercial manufacturing process, and are now finalizing the supporting documentation to file for licensure," said James Porter, vice president of development and manufacturing at Elusys. "Completing the manufacturing validation work is an important milestone along the path to BLA licensure and confirms our ability to supply commercial quantities of ETI-204 to the Strategic National Stockpile"
Additionally, Lawrence Gyenes has been appointed chief financial officer. Mr. Gyenes has more than 25 years of experience in financial leadership within the life sciences industry. Most recently he served as senior finance executive at Columbia Laboratories and previously held finance positions at Searle, Reliant, Savient, Zila, and Acusphere.
"We will look to Larry's extensive experience to inform and direct our fiscal strategy as we progress through the final stages of product development and the fulfillment of our BARDA contracts for advanced development of ETI-204," said Elizabeth Posillico, Ph.D., chief executive officer of Elusys.