Akston has reclaimed all rights to AKS-452, a room temperature stable, low-cost, protein subunit COVID-19 vaccine
Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, has ended its AKS-452 licensing, manufacturing, and commercialisation agreement with Stelis Biopharma, an arm of Strides Pharma Science.
Akston has reclaimed all rights to AKS-452, a room temperature stable, low-cost, protein subunit COVID-19 vaccine. AKS-452 has completed a Phase II/III clinical trial in India, with data showing a robust safety profile and a 91% seroconversion rate at Day 56. Volunteers in the study had antibody titers that persisted at statistically-significant high levels through six months, with serum showing protection against variants of concern, including Delta and Omicron.
Akston is now working with a new CDMO in India to produce the promising AKS-452 COVID “universal” booster release.
The results of Phase I/II randomised, an open-labelled study in The Netherlands and published in vaccine showed that seroconversion rates reached 100 per cent with enhanced potencies of SP/RBD-ACE2 binding inhibition and live virus neutralisation.
In a Phase II study in the Netherlands of AKS-452 as a ‘universal’ booster vaccine, 93 per cent of subjects previously vaccinated with Pfizer, Moderna, Johnson & Johnson (Janssen), and AstraZeneca vaccines showed an increase in neutralising antibody titers after receiving a single dose. The average neutralization titers across all subjects increased four-fold against the Wuhan strain and five-fold against the Omicron variants at Day 28. There were no safety issues reported.
Todd Zion, President & CEO, Akston Biosciences, said, “I am confident that AKS-452 can attain Emergency Use Authorization (EUA) in India, especially as a ‘universal’ booster vaccine capable of increasing and broadening people’s immune response as their previous immunity wanes and new variants arise. We concluded that Akston and a different CDMO were better placed to move ahead with the AKS-452 development plan at a rapid pace, so we reclaimed the rights.”
