Akston Biosciences Announces Positive Interim Phase II Results from COVID “Universal” Booster Vaccine Trial

Study investigated boosting those previously vaccinated with EMA-registered vaccines

• 93% of those previously vaccinated had higher neutralizing antibody titers after a single dose of AKS-452
• Sera collected from participants 28 days after administration of a 90 µg booster dose of the COVID-19 vaccine showed a substantial increase in neutralizing antibody response above pre-booster levels against original wild-type, delta and omicron BA 1-5 variants
• No Adverse Effects and no Serious Adverse Effects attributable to AKS-452 occurred during the study

Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, today announced top-line clinical results for its Phase II COVID-19 “universal” booster vaccine, AKS-452. An interim analysis of the data found that 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 of AKS-452. 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.

The non-randomized, open-label, safety, and efficacy study was conducted and managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials that previously conducted Phase I and II trials for AKS-452 in the Netherlands. Seventy healthy participants between the ages of 18 and 85 received one 90 µg dose of the AKS-452 antigen. The vaccine was well tolerated with data indicating a favorable safety profile, similar to that of the registered vaccines. Antibody levels, virus neutralization activity, and T cell response will be measured at intervals over the next nine months.

“The favorable safety and immunogenicity profiles at the interim analysis of this study, particularly against variants, support a Phase III universal booster study for AKS-452,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “Immunity from infection or vaccination quickly wanes and new waves of elusive strains are presenting continuing challenges. Boosting immunity in vulnerable populations will be needed for years to come and vaccines must be low cost and easy to distribute.”

A 1,600 subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine was completed earlier this year in India. The positive results from that study have been submitted as part of an Emergency Use Application in India.

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

About TRACER

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

About Akston Biosciences

Akston Biosciences Corporation leverages its novel 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 GMP 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.

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