Headquartered in Cambridge, Massachusetts, Affinivax is ‘pioneering the development of a novel class of vaccines’, the most advanced of which are next-generation pneumococcal vaccines. This includes pneumonia, meningitis, bloodstream infections, and milder diseases such as sinusitis and otitis media and remains a ‘significant unmet medical need’ despite the availability of current pneumococcal vaccines, according to the company.
While there are many different pneumococcal serotypes, the number of serotypes in current vaccines is limited due to the degree of immunological interference observed when using existing conjugation technologies.
Affinivax has developed its Multiple Antigen Presenting System (MAPS), a novel technology that supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent pneumococcal serotypes and potentially creating higher immunogenicity than current vaccines, according to the company. Its most advanced vaccine candidate (AFX3772) includes 24 pneumococcal polysaccharides plus two conserved pneumococcal proteins (compared to up to 20 serotypes in currently approved vaccines). A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development.
In phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. In July 2021, the US Food and Drug Administration granted Breakthrough Therapy designation for AFX3772 to prevent S. pneumoniae invasive disease and pneumonia in adults 50 years and above.
Phase III is expected to start in the near term, with clinical trials in the paediatric population set to follow later this year.
GSK’s existing vaccine portfolio includes Boostrix, Cervarix, Fluarix QIV, Priorix, Shingrix and Varilrix.
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “The proposed acquisition further strengthens our vaccines R&D pipeline, provides access to a new, potentially disruptive technology, and broadens GSK’s existing scientific footprint in the Boston area. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”