Akston Biosciences Announces Positive Preliminary Phase II Results From COVID “Universal” Booster Vaccine Study

BEVERLY, Mass.–(BUSINESS WIRE). An interim analysis of the data found that 93% of subjects previously vaccinated with vaccines from Pfizer, Moderna, Johnson & Johnson (Janssen) and AstraZeneca had an increase in neutralizing antibody titers after receiving a single dose of AKS-452. The mean neutralization titers of all subjects increased 4-fold versus the Wuhan strain and 5-fold versus the Omicron variants at day 28. No security issues have been reported.

The non-randomized, open-label safety and efficacy study was conducted and administered by TRACER Europe BV, a CRO specializing in accelerated clinical trials and previously conducted Phase I and II studies for AKS-452 in the Netherlands . 70 healthy participants between the ages of 18 and 85 received a 90 µg dose of the AKS-452 antigen. The vaccine was well tolerated, with data suggesting a favorable safety profile, similar to that of licensed vaccines. Antibody levels, virus neutralization activity and T cell response will be measured periodically over the next nine months.

“The favorable safety and immunogenicity profiles in the interim analysis of this study, particularly versus variants, support a universal Phase III booster study of AKS-452,” said Todd Zion, Ph.D., President and CEO of Akston Biosciences. “Immunity to infection or vaccination is eroding rapidly, and new waves of elusive strains pose constant challenges. Boosting immunity in vulnerable populations will be necessary in the years to come, and vaccines need to be inexpensive and easy to distribute.”

A 1,600-subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine was completed in India earlier this year. The positive results of this study were submitted as part of an emergency application in India.

AKS-452 is a second generation vaccine based on Akston’s novel Fc fusion platform. Its composition provides a direct presentation to the immune system and robust protection against viral variants. Using proven antibody technologies, it inherently supports high production yields and stability at high temperatures.


TRACER Europe BV (“TRACER”) is a Clinical Research Organization (CRO) specializing in fast-track solutions for testing innovative biological medicines and is a founding member of the COVID-19 Rapid Cure Task Force (RCTF). TRACER and its partners provide its customers with the expertise, infrastructure and capacity to rapidly generate accurate first-in-human clinical data. www.tracercro.com.

About Akston Biosciences

Akston Biosciences Corporation is using its novel Fc fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins and therapies for autoimmune diseases. Akston was founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.). This is co-located with its research and process development laboratories at its Beverly, Massachusetts location. Visit www.akstonbio.com for more information.

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