Biodefense biopharma firm Elusys Therapeutics was awarded an additional $14.5 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to support expanded human safety trials with ETI-204 (Anthim), its Phase II-stage monoclonal antibody candidate for treating anthrax infection. The firm has now received $149 million under two advanced development contracts from BARDA, and could receive up to $211 million in funding for the project. Last month the firm banked $50.2 million in BARDA funding to conduct definitive efficacy studies in animals and complete validation of the commercial manufacturing process for ETI-204.
ETI-204 is a humanized, deimmunized monoclonal antibody targeting the protective antigen of B. anthracis, which neutralizes the lethal effects of anthrax toxins. The antitoxin antibody is in development for biodefense applications. Three studies assessing the pharmacokinetics and safety of intravenous administration of ETI-204 have already been carried out.
The new BARDA funding will be used to conduct final, expanded safety studies of intravenously administered ETI-204, and a dose-escalation study for intramuscular administration. Funding has been received separately from the U.S. DoD to support development of an IM formulation, which Elusys says will facilitate rapid administration of antitoxin therapy to large numbers of people in an emergency situation.
The firm is working with FDA on design of the ETI-204 Phase III program, in preparation for its anticipated end of Phase II meeting. “As we continue to reach milestones in the late stages of our development program, we are pleased to have the ongoing support of the U.S. Government to evaluate not only IV administration, but also the more rapid, cost-effective IM administration of ETI-204,” states Elizabeth Posillico, Ph.D., Elusys president and CEO. “Advancing the development of both IV and IM administration of our antitoxin could provide two important options in the prevention and treatment of inhalational anthrax following a biowarfare attack.”