IBT in collaboration with Abviro, LLC (Bethesda, MD) received a collaborative SBIR grant from NIH, entitled Development of a Universal Immunotherapeutic for Influenza Viruses.
Influenza virus (INFV) results in global seasonal and pandemic outbreaks estimated to cause severe illness in 3 to 5 million people annually causing significant morbidity and economic impact. Vaccination is currently the most effective disease control intervention, but constant annual surveillance of circulating viruses is necessary to predict effective vaccine composition. Currently available influenza drugs only result in modest clinical efficacy with limited effectiveness due to viral resistance.
In this fast track SBIR IBT and Abviro will perform advanced development activity for the lead product 3I14 as broad-spectrum antibody therapeutic against multiple influenza A strains. In phase I, we will establish a highly productive stable CHO Research Cell Bank and generate a characterized stable lot of 3I14 to support phase II objectives. Phase II will characterize the 3I14 dose response in INFV A mouse models and therapeutic window, establish the pharmacokinetics and tolerability of 3I14 in mice, and confirm 3I14 does not lose potency as a result of viral resistance. Completion of these studies will position the product for IND-enabling manufacturing, efficacy and toxicology studies necessary to advance 3I14 to clinical studies.