Akston Biosciences Ends Vaccine Partnership with Stelis, Continues to Advance COVID Universal Booster EUA
08 Mar 2023
VaccineClinical ResultLicense out/inPhase 2mRNA
BEVERLY, Mass. and BANGALORE, India--(BUSINESS WIRE)--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 vaccineCOVID-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.
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.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Indications
Targets
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.