US-based 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, in Bengaluru.

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 contract development and manufacturing organisation (CDMO) in India to produce the promising AKS-452 COVID “universal” booster release.

The results of a Phase I/II randomized, open-labelled study in The Netherlands and published in Vaccine showed that seroconversion rates reached 100% with enhanced potencies of SP/RBD-ACE2 binding inhibition and live virus neutralization.

Todd Zion, Ph.D., President & CEO of Akston Biosciences, said, “I am confident that AKS-452 can attain Emergency Use Authorisation (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 the AKS-452 development plan at a rapid pace, so we reclaimed the rights.”