Akston Biosciences Ends Vaccine Partnership with Stelis, Continues to Advance COVID Universal Booster EUA

 

  • 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

 

BEVERLY, Massachusetts, and BANGALORE, India – March 8, 2023 – 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 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 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 akstonbio.com.

Contact:
Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905
lpendergastsavage@birnbachcom.com