Affinivax's novel vaccine candidate, ASP3772 offers the potential to provide broader protection against pneumococcal disease.
February 13, 2019, the first subject was dosed with ASP3772, a novel MAPS vaccine targeting Streptococcus pneumoniae (pneumococcus). The clinical study protocol – “A Phase 1/2, Randomized, Single Ascending Dose Study in Adults (Stage 1) and Randomized, Single Ascending Dose-Finding Study in Elderly Subjects (Stage 2) with ASP3772, a Pneumococcal Vaccine” – was initiated by Affinivax’s development partner, Astellas Pharma, Inc.
This followed the successful submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in December 2018.
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator Prevnar 13 (PCV13) in adults 18 to 64 years of age in Stage 1.
Stage 2 will evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator PCV13 in elderly 65 to 85 years of age.
In addition, Stage 2 will evaluate the immunogenicity of 3 different dose levels of ASP3772 relative to the response seen following administration of Pneumovax 23 (PPSV23) for the serotypes not included in PCV13.
Affinivax and Astellas entered into an exclusive worldwide license agreement in February 2017.
The strategic partnership leverages Affinivax’s proprietary MAPS vaccine technology platform utilizing Affinivax’s process development and analytical expertise to advance a novel pneumococcal MAPS vaccine, with Astellas playing a leadership role in development and commercialization.
The Multiple Antigen Presenting System (MAPS) platform is Affinivax’s proprietary, next-generation vaccine technology.
It is designed to create novel preventive and therapeutic vaccines. MAPS uniquely presents key epitopes of the desired antigens (polysaccharides and/or proteins) to induce a robust and broad immune response against challenging diseases.
Clinical Trial NCT03803202: A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine