In Collaboration with Astellas, Affinivax, Inc. Announces Initiation of Phase 1/2 Clinical Study of ASP3772, its novel Pneumococcal MAPS Vaccine.
Affinivax is advancing a next generation vaccine technology platform to enable the development of vaccines that provide the highest level of protection against challenging infectious diseases. The partnership will utilize Affinivax’s proprietary MAPS vaccine technology platform to advance a novel MAPS vaccine targeted to prevent and reduce the spread of pneumococcal disease.
CAMBRIDGE, Mass.—-Affinivax, Inc. announced that the first subject has been dosed with ASP3772, its 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. (“Astellas”) following the successful submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in December 2018.
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. This has resulted in the development of ASP3772, a novel vaccine which offers the potential to provide broader protection against pneumococcal disease. The initiation of clinical testing for ASP3772 triggered a milestone payment of $10 million to Affinivax from Astellas.
“Advancing this program from the labs at Boston Children’s Hospital to clinical testing in less than 5 years realizes our vision to utilize the MAPS technology platform to offer a range of safe and effective vaccines targeting multiple bacterial pathogens,“ said Richard Malley, MD, Affinivax’s Scientific Founder, Professor of Pediatrics at Harvard Medical School, and the Kenneth McIntosh Chair in Pediatric Infectious Diseases at Boston Children’s Hospital. “We believe that MAPS, in contrast to traditional vaccines, offers a unique way to present the key epitopes of the desired antigens (polysaccharides and/or proteins) to induce a robust and broad immune response. We now look forward to confirming this in clinical trials.”
“The initiation of clinical testing of ASP3772 is a major milestone for the development of our MAPS technology platform and for our company” said Steven B. Brugger, CEO of Affinivax, Inc. “I want to recognize the tremendous effort on the part of the entire Affinivax team, in collaboration with our Astellas colleagues, to achieve this important milestone. We now look forward to advancing this important vaccine towards clinical proof of concept and continuing to work to bring an improved pneumococcal vaccine to patients.”