The Biomedical Advanced Research and Development Authority (BARDA) awarded Hebrew University of Jerusalem spinout Atox Bio with a contract that could be worth up to $24 million to develop its lead candidate AB103 to treat necrotizing soft tissue infections (NSTI), infections caused by biothreats, and public health threats that end in sepsis.
Atox Bio says the contract will cover manufacturing activities, regulatory activities, and a clinical trial of AB103 in patients with NSTI. BARDA awarded the contract for $4.4 million over a base period of 18 months, but the total value of the award could go up to $24 million over 4.5 years should BARDA choose to exercise subsequent option periods.
AB103 is a rationally designed short peptide discovered by Raymond Kaempfer, Ph.D., and Gila Arad, Ph.D., of the Hebrew University that can modulate a patient’s inflammatory response through binding to the CD28 dimer interface. The candidate works by modulating—not inhibiting—the patient’s immune system, which the firm believes could potentially reduce the chance of rapid generation of drug resistance and may provide a broad-spectrum approach to treat infections.
Atox Bio says that AB103 is the first product specifically developed for NSTI and has received fast-track designation from the FDA and orphan drug status from both the FDA and EMA. AB103, the company adds, has already successfully completed a Phase II study in patients with NSTI.
“We are honored that BARDA has recognized the potential of AB103, a novel host oriented therapeutic, to offer a new approach to treating severe infections where there are currently no approved therapies,” Atox Bio CEO Dan Teleman said in a statement. “We look forward to working with BARDA to advance the development of AB103 in NSTI and exploring its potential in bioterror pathogens.”