Nonclinical Development of an Improved Polio Vaccine

摘要 在SBIR第二阶段，我们开发了一种改进的脊髓灰质炎候选疫苗，主要用于 在后根除时代。我们称候选者为UltraIPVTM，因为它是使用UVC- 失活方法。与现有的IPV产品相比，UltraIPVTM有重大改进， 例如IPOL(赛诺菲)和VeroPol(Staten血清研究所)。超强IPVTM技术是 与减毒病毒株兼容，可减少对生物安全和生物安全的担忧 制造业。该方法快速简单；只需30秒的UVC曝光即可 失活。紫外线灭活过程中，保护性氨基酸的降解较少 表位，这导致每毫克病毒有更多的疫苗单位，从而允许每批次更多的剂量 降低了每剂的成本。最后，产品在多次冻融循环中是稳定的， 这对长期储存在国家储备中是个好兆头。在此SBIR IIB阶段中，我们建议 完成三价超IPVTM的关键非临床开发活动。这些 活动包括生产放大、GLP动物安全性和免疫原性研究，以及 提交IND申请，为临床试验做准备。我们已经组建了一个主题团队 具有必要经验的事项专家，可通过IND流程和 更远一点。对于这个产品，我们有几个开发途径，包括早期- 潜在许可证持有者的舞台利益。

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.