Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, has ended its AKS-452 licensing, manufacturing, and commercialization agreement with Stelis Biopharma Ltd, an arm of Strides Pharma Science Ltd.

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 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 AKS-452 COVID “universal” booster vaccine.

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

In a Phase II study in the Netherlands of AKS-452 as a “universal” booster vaccine, 93% of subjects previously vaccinated with Pfizer, Moderna, Johnson & Johnson (Janssen), and AstraZeneca vaccines showed an increase in neutralizing antibody titers after receiving a single dose.

The average neutralization titers across all subjects increased 4-fold against the Wuhan strain and 5-fold against the Omicron variants at Day 28. There were no safety issues reported.

Todd Zion, President & CEO of 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.”

Zion added: “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.”