ASP3772 Pneumococcal Vaccine Description
Affinivax ASP3772 vaccine candidate is designed to offer B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides, as well as two conserved pneumococcal proteins.
ASP3772 utilizes the Multiple Antigen Presenting System (MAPS) platform, Affinivax’s proprietary, next-generation vaccine technology. The MAPS technology platform uses proprietary chemistry that capitalizes on the highly specific and durable non-covalent affinity binding between biotin and rhizavidin, a biotin-binding protein.
The highly stable MAPS complex created by this affinity binding contributes to a simple, modular, and efficient approach to developing novel vaccines and immunotherapies. Conventional vaccine conjugation technology seeks to optimize the generation of protective antibody responses mainly to polysaccharide antigens, using the protein antigen as a carrier. In stark contrast, a MAPS vaccine can present both the polysaccharide and the protein antigens to the host immune system to induce both a B- and T-cell immune response.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for ASP3772 to prevent pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older on July 13, 2021. The results inform the FDA decision of the Phase 2 data. The designation is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.
Affinivax is advancing a next-generation technology platform to enable the development of vaccines and immunotherapies. Affinivax is a clinical-stage biopharmaceutical company pioneering developing a novel class of vaccines designed to induce a broad and robust protective immune response to both disease-relevant polysaccharides and disease-relevant proteins in a single vaccine. Affinivax was founded in 2014 with a seed investment from the Bill & Melinda Gates Foundation and an exclusive license to the MAPS™ technology from Boston Children’s Hospital.
For more information, visit www.affinivax.com. Affinivax Headquarters is located at 301 Binney St., Suite 302, Cambridge, MA 02142.
ASP3772 Pneumococcal Vaccine Indication
ASP3772 is a vaccine candidate that offers the potential to provide broader protection against pneumococcal disease. Streptococcus pneumoniae is a bacterium frequently found in the upper respiratory tract of healthy children and adults and can cause serious infections ranging from pneumonia, meningitis, and sepsis, representing a major global health problem.
ASP3772 Pneumococcal Vaccine Dosage
Study participants received a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels.
ASP3772 Pneumococcal Vaccine Development News
July 13, 2021 - Affinivax, Inc. and Astellas Pharma Inc. announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. The results from the Phase 2 clinical trial demonstrated that ASP3772 was well tolerated. ASP3772 also exhibited an antibody response to each of the 24 polysaccharides and additional antibody response to the conserved pneumococcal proteins.
April 23, 2020: Affinivax Announces $120 Million Series B Financing to Advance Pipeline of Novel MAPS Vaccines and Immunotherapies.
February 13, 2019: The first subject was dosed with ASP3772, a novel MAPS vaccine targeting Streptococcus pneumoniae (pneumococcal). This followed the successful submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in December 2018.
February 28, 2017: Affinivax, Inc. and Astellas Pharma Inc. announced they have entered into an exclusive worldwide license agreement to develop and commercialize a vaccine targeting Streptococcus pneumoniae (pneumococcus).
ASP3772 Pneumococcal Vaccine Clinical Trials
The ASP3772 clinical development program includes indications for protection against Streptococcus pneumoniae infections in both adults and infants. The clinical trials can be found here.