INTEGRATED RESEARCH ASSOCIATES, LLC — Department of Health and Human Services SBIR Phase I: 85

Description

Recent cases of acute flaccid myelitis (AFM) have been associated with enteroviruses, and the most important enterovirus implicated in worldwide cases is enterovirus 71 (EV-A71). Recently in the United States, enterovirus 68 (EV-D68) has been strongly associated with AFM cases, although EV-A71 has also been detected in some cases. Currently, there are no approved therapeutics for AFM case management and supportive care is the only option. Here, two potent lead therapeutic mAbs for EV-A71 with demonstrated efficacy and novel mechanisms of action will be developed and bispecific antibody (bSAb) technology will be employed to combine two potent EV-A71 mAbs into a single antibody product. The successful strategy used to identify these mAbs will be applied to EV-D68 to discover and develop analogous therapeutic candidates for EV-D68. Applying an approach in which further EV-A71 mAb development and EV-D68 mAb discovery modeled on EV-A71 successes are united should facilitate rapid progress. As enterovirus diagnosis in neurological cases is difficult, therapeutics that targets both EV-A71 and EV-D68 could enable treatment without knowing the specific virus causing AFM. Importantly, if Phase I is successful, bSAbs targeting both viruses simultaneously will be made in Phase II to generate a single product to treat both viruses