�
BEVERLY, Mass. and BANGALORE, India–(BUSINESS WIRE)–#VIE–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 peoples 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 worlds 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.
Contacts
Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905 | lpendergastsavage@birnbachcom.com
CAIRO, EGYPT - Media OutReach Newswire - 23 December 2024 - Eand, Novo Nordisk, BSH,…
Trend Vision One™ – Email and Collaboration Security is a critical part of Trend’s centralized…
SINGAPORE - Media OutReach Newswire - 23 December 2024 - Madame Tussauds Singapore is proud…
BANGALORE, INDIA / SINGAPORE - Media OutReach Newswire - 23 December 2024 - GangaGen announced…
TAIPEI, TAIWAN - Media OutReach Newswire - 23 December 2024 – The 2024 Christmasland in…
Hungarian-based technology leader underscores its commitment to education, sustainability, and innovation SINGAPORE - Media OutReach…