Sales of pneumococcal vaccines are dominated by Pfizer, followed by Merck, each stepping up competition with recent FDA approvals of vaccines that offer broader protection.GlaxoSmithKline wants a bigger share of this market, so it pledged $3.3 billion Acquired Affinivaxa clinical-stage vaccine developer with a Phase 3 vaccine candidate ahead of pneumococcal vaccines marketed by its competitors.
The deal announced Tuesday broke down into a $2.1 billion upfront payment to Cambridge, Massachusetts-based Affinivax, whose most advanced product candidate is an adult pneumococcal vaccine. Privately held Affinivax could fetch $1.2 billion from GSK, depending on whether the biotech achieves two clinical milestones with its pediatric pneumococcal vaccine.
pneumococcal disease caused by Streptococcus pneumoniae. There are more than 100 strains of this bacterium that can cause infections such as sepsis, pneumonia, and meningitis. The pneumococcal vaccine market is dominated by Prevnar 13, a Pfizer vaccine that protects against 13 strains. Vaccine developers have been working to increase that number. last year, FDA approves Pfizer’s Prevnar 20a vaccine against 20 pneumococcal strains. Merck subsequently approved Vaxneuvance, which protects against 15 strains. Affinivax’s lead vaccine candidate, AFX3772, is designed to provide protection against 24 pneumococcal strains. A preclinical Affinivax vaccine candidate targets more than 30 strains.
The challenge with adding more strains to a pneumococcal vaccine is capacity. Currently available pneumococcal vaccines are conjugate vaccines, which are made by combining an antigen with the protein that carries it. An antigen is a polysaccharide, a chain of sugar molecules from the outer shell of bacteria. To prevent more strains, the vaccine needs to have more polysaccharides added. It is here that Affinivax’s conjugate vaccine may have an advantage.
Affinivax has developed a proprietary method of combining polysaccharides with proteins. In a single vaccine, Affinivax injections are able to deliver a greater combination of polysaccharides and proteins to the immune system than vaccines made with traditional conjugation chemistry. The biotech company says these combinations induce a broad protective immune response in both B and T cells. In addition to broader protection, Affinivax claims its technology offers the potential for a stronger immune response than currently available vaccines. The platform Affinivax technology is called MAPS, short for Multiple Antigen Presentation System.
Development of Affinivax’s pneumococcal vaccine candidate (previously known as ASP3772) was funded in collaboration with Astellas Pharma Start in 2017. In addition to the 24 strains, the vaccine targets two “conserved proteins,” meaning they are present in different pneumococcal strains.Last July, the companies reported that Results of the Phase II Study In nearly 800 adults, antibody responses were shown to each of the vaccine’s 24 polysaccharides, as well as additional antibody responses to conserved pneumococcal proteins. The vaccine was well tolerated by patients and no serious adverse reactions were reported.
Earlier this year, Affinivax Reacquired from Astellas Global rights to a pneumococcal vaccine candidate, with an up-front payment of $65 million to its former partners. Astellas is eligible to receive milestone payments related to progress on the vaccine, now rebranded as AFX3772, and may also receive royalties from sales if it hits the market. The Japanese pharmaceutical company is also eligible for royalties on a next-generation pneumococcal vaccine based on MAPS technology.
GSK already has the pneumococcal vaccine Synflorix. The product protects against 10 strains of pneumococcus and generated sales of £357m (~$450m) in 2021, down 11% year-on-year. Attributed to to reduce demand in emerging markets. Sales of the Prevnar line were also down 11%, but it’s still a bigger franchise, accounting for more than Global sales of $5.2 billion in 2021By acquiring Affinivax, GSK was not only better able to compete in the pneumococcal vaccine market, but also gained technology that could help it develop vaccines against other pathogens.
Affinivax started in 2013 by CEO Steven Brugger on the basis of research by Rick Malley, an infectious disease specialist at Boston Children’s Hospital and a professor of pediatrics at Harvard Medical School. Affinivax’s MAPS technology was co-invented by Harvard Pediatrics professors Fan Zhang and Yingjie Lu, who are also the startup’s scientific co-founders.
While the pneumococcal vaccine was Affinivax’s initial focus, the platform technology is being applied to other targets as well. The biotech company received seed funding from the Bill & Melinda Gates Foundation in 2014, $346 million raised inside past two years as it expands its scope to healthcare-related infections such as Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureusand Clostridium difficile. These procedures are preclinical. The company also has exploratory programs in SARS-CoV-2 and melanoma.
GlaxoSmithKline’s acquisition of Affinivax comes at a critical time for the biotech company, which is looking forward to pivotal testing in adult pneumococcal vaccine and paediatric clinical trials, and which needs to be funded without Astellas’ deep pockets. Both provide funding. GlaxoSmithKline (GSK) is taking on that responsibility and said it expects to start a phase 3 clinical trial soon. A Phase 1/2 pediatric clinical trial is planned to begin later this year.
“The proposed acquisition further strengthens our vaccine development pipeline, delivering a new and potentially disruptive technology,” Hal Barron, GSK’s chief scientific officer and president of R&D, said in a prepared statement. , and expands GlaxoSmithKline’s existing scientific footprint in the Boston area.” “We look forward to working with Affinivax’s many talented people, combined with our industry-leading development, manufacturing and commercialization capabilities, to bring this exciting opportunity to those in need. Exciting new technology.”
Public area picture by the Centers for Disease Control and Prevention
