ASP3772 Pneumococcal Vaccine
Affinivax ASP3772 vaccine candidate offers cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides and two conserved pneumococcal proteins. ASP3772 utilizes the Multiple Antigen Presenting System (MAPS) platform, Affinivax’s proprietary, next-generation vaccine technology. The MAPS tech ology platform uses proprietary chemistry that capitalizes on the highly specific, durable, non-covalent affinity binding between biotin and rhizavidin, a biotin-binding protein.
The highly stable MAPS complex creates affinity binding and creates tributes 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 bot- and T-cell immune response.
On July 13, 2021, 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. The results formed the FDA's decision regarding the Phase 2 data. The design is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.
In May 2022, GlaxoSmithKline plc (GSK) pledged $2.1 billion and up to $1.2 billion in development milestone payments to take over Affinivax Inc. For more information, visit www.affinivax.com. Affinivax Hea quarters 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 demonstrated that ASP3772 was well tolerated. ASP3772 also exhibited an antibody response to each of the 24 polysaccharides and an 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 boults and infants. The clinical trials can be found here.