Business Wire India
Akston has reclaimed all commercial rights to AKS-452, its room temperature stable COVID-19 vaccine
Akston is continuing its progress to secure Emergency Use Authorization (EUA) in India and has begun working with a new CDMO to produce AKS-452
Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today it has ended its AKS-452 licensing, manufacturing, and commercialization agreement with Stelis Biopharma Limited, 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 promising AKS-452 COVID "universal" booster vaccine.
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.
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, Ph.D., 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. 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."
About Akston Biosciences
Akston Biosciences Corporation leverages its Ambifect™ Fc-fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world's first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston owns and operates a cGMP biologics cleanroom facility that manufactures kilogram-scale batches of drug substance. This, along with its research and process development laboratories, are located at its Beverly, Mass. location. Additional information is available at www.akstonbio.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230306005704/en/
BEVERLY, Mass., United States & Bangalore, Karnataka, India