Affinivax, Inc. and Astellas Pharma Inc. announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. Developed using Affinivax’s proprietary MAPS (Multiple Antigen-Presenting System) platform technology, ASP3772 is designed to offer both B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides, as well as two conserved pneumococcal proteins. 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, as well as an additional antibody response to the conserved pneumococcal proteins. The Phase 2 data for ASP3772 were delivered in an oral presentation at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), taking place online from 9 – 12 July 2021.
The U.S. Food and Drug Administration (FDA) has also granted Breakthrough Therapy designation for ASP3772 for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older. The FDA decision is informed by the results of the Phase 2 data. The FDA’s Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. 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.
The Phase 2 clinical trial1 of ASP3772 was conducted in 503 adults 65 to 85 years of age, and 293 adults received ASP3772, 97 adults received Prevnar13 and 113 adults (who were previously vaccinated with Prevnar13) received Pneumovax23. The primary objective was to evaluate safety/tolerability and reactogenicity of ASP3772 compared to Prevnar13. The secondary objective was to evaluate the immunogenicity of ASP3772, versus Prevnar13 or Pneumovax23. A summary of the results is below:
“Extending the coverage to 24 Streptococcus pneumoniae strains, we believe that ASP3772 has the potential to offer broader protection than any pneumococcal vaccine currently on the market or in clinical testing today , and we look forward to continuing to advance this important vaccine candidate through clinical trials in both adults and infants,” said Steven B. Brugger, CEO of Affinivax. “Demonstrating strong immunogenicity to both the polysaccharides and proteins in our ASP3772 vaccine also represents a significant step forward in clinically validating our MAPS™ technology platform and highlights the promising potential for future MAPS™ vaccines in our pipeline.”
“The MAPS™ technology offers new ways to address unmet needs for infectious diseases, such as Streptococcus pneumoniae, that affect millions of people” said Salim Mujais, M.D., Senior Vice President and Therapeutic Area Head, Medical Specialties, Astellas. “We believe that ASP3772 can offer significant potential to provide broader protection from pneumococcal infections that impact both infants and adults in our global community.”
The ASP3772 clinical development program includes indications for protection against Streptococcus pneumoniae infections in both adults and infants. The pivotal Phase 3 registration clinical trials in adults are under preparation
In February 2017, Affinivax and Astellas entered into an exclusive worldwide license agreement to develop and commercialize a ASP3772 using Affinivax’s proprietary MAPS.
Date: Jul 13, 2021
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