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news.Elusys Therapeutics has completed validation of the commercial manufacturing process for ETI-204, an anthrax antitoxin currently undergoing Phase 3 clinical trials in healthy volunteers.
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ETI-204 is a potential target for future acquisition into the Strategic National Stockpile, the US government’s repository of critical medical supplies for biowarfare preparedness. ETI-204 is the only anthrax anti-toxin in advanced stages of development that is being investigated for intravenous (IV) treatment and intramuscular (IM) prophylaxis administration.
The ability to administer an antitoxin via IM injection may provide a valuable alternative to IV injection in an emergency where medical resources and personnel may be limited.
Elusys development and manufacturing vice president James Porter noted that the company has completed all the planned validation activities for its commercial manufacturing process, and is now finalizing the supporting documentation to file for licensure.
"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," Porter added.
The company also announced the appointment of Lawrence Gyenes, formerly of Columbia Laboratories, as CFO. Gyenes has over 25 years of experience in financial leadership within the life sciences industry. Larry served as the senior finance executive at Searle, Reliant, Savient, Zila, Acusphere and, most recently, at Columbia Laboratories.
Gyenes has served as CFO at six public companies and led CompuServe’s initial public offering in 1996. He has been at the center of the development and launch of such well-known brands as Ambien, NutraSweet, Equal, Pearle Vision Centers and RandMcNally.com.
His extensive experience includes the multi-billion dollar divestitures of DuPont Pharmaceuticals, CompuServe and Helene Curtis, as well as multiple financings, acquisitions, joint ventures and strategic alliances.
Gyenes holds a bachelor of science in Accounting from the University of Illinois and an MBA from the University of Chicago.
ETI-204 is a high-affinity, humanized and deimmunized monoclonal antibody that targets the Protective Antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to Protective Antigen.
It is an investigational agent being developed for treatment and prophylaxis of inhalational anthrax. ETI-204 is formulated as a solution and is being evaluated for intravenous (IV) and/or intramuscular (IM) administration.
ETI-204’s efficacy and safety are being studied in animal models of inhalational anthrax and safety studies are being conducted with healthy human volunteers. Three studies assessing safety and pharmacokinetics of IV administration of ETI-204 in adult volunteers have been completed.
The more common adverse events related to ETI-204 administration, across the three studies, included upper respiratory tract infection, nausea, headache, nasal congestion and erythema. ETI-204 was granted Fast Track status and Orphan Drug Designation by the FDA.
This program is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), the Department of Health and Human Services (HHS).