Nonclinical Development of an Improved Polio Vaccine

Abstract In an SBIR Phase II, we developed an improved polio vaccine candidate, primarily for use in the post-eradication era. We call the candidate, ultraIPVTM, because it is produced using a UVC- inactivation method. UltraIPVTM has major improvements compared to existing IPV products, such as IPOL (Sanofi) and VeroPol (Staten Serum Institute). The ultraIPVTM technology is compatible with attenuated virus strains which reduce biosafety and biosecurity concerns during manufacturing. The method is rapid and simple; only 30 seconds of UVC exposure is required for inactivation. The UVC-inactivation process causes less amino acid degradation in protective epitopes, which results in more vaccine units per milligram of virus allowing more doses per batch with reduced costs per dose. Finally, the product is stable through multiple freeze-thaw cycles, which bodes well for long-term storage in national stockpiles. In this SBIR Phase IIB, we propose to complete critical non-clinical development activities for the trivalent ultraIPVTM. These activities include manufacturing scale-up, GLP animal studies of safety and immunogenicity, and IND application submission to prepare for clinical trials. We have assembled a team of subject matter experts with the necessary experience to advance ultraIPVTM through the IND process and beyond. For this product, we have several development avenues ready post-IND, including early- stage interest from potential licensees.