Akston Biosciences Announces Publication in Vaccine of Positive Data for a Room Temperature Protein Subunit COVID-19 Vaccine

Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced publication of positive results from a 60-subject, open-label, Phase I trial of AKS-452, its shelf stable protein subunit COVID-19 vaccine candidate. The adjuvanted vaccine was generally well-tolerated and produced a 100% seroconversion rate in the 90 µg single-dose regimen, as well as in the 45 µg and 90 µg two-dose regimens. The article in the current issue of Vaccine is available here.

The trial met all primary and secondary endpoints, indicating minimal reactogenicity and optimized immunogenicity. These results were subsequently confirmed in a Phase II trial.

A recombinant subunit vaccine, AKS-452 comprises an Fc fusion protein of the SARS-CoV-2 viral spike protein receptor binding domain (RBD) antigen that is engineered to preserve effectiveness against viral variants.

"An effective COVID vaccine that is transportable without cold chain and is substantially less expensive than current vaccines ? with cost savings also attributable to Akston's high volume, low-cost manufacturing platform ? can address many of the shortcomings that have slowed distribution and vaccine access in countries around the world," said Todd Zion, Ph.D., President & CEO of Akston Biosciences. "A single production line can rapidly produce more than a billion doses of AKS-452 per year using established antibody production infrastructure available worldwide, creating an abundant vaccine resource."

The single-center, open-label Phase I dose-finding and safety study was conducted in the Netherlands with 60 healthy adults (18?65 years) receiving one or two doses 28 days apart of 22.5 µg, 45 µg, or 90 µg of AKS-452. A 100% seroconversion rate was achieved in the 90 µg cohort at 28 days, and in the 90- and 45 µg cohorts at 56 days. AEs were mild and comparable to those with currently approved vaccines. There were no SAEs.

A Phase II/III trial for primary vaccination is expected to begin in India in Q1 2022, and studies evaluating AKS-452 as a booster are being planned.

About AKS-452

Based on Akston's proprietary Fc fusion protein platform, AKS-452 is a SARS CoV-2 protein subunit vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. As the primary locus for infection, the RBD is highly conserved among mutated forms of the virus, and preclinical studies have demonstrated robust antibody neutralization of the B.1.1.7 (Alpha) and B.1.351 (Gamma) variants. The vaccine has been engineered to use standard, low-cost, antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year.

About Akston Biosciences

Akston Biosciences Corporation leverages its novel 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 has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing facility and research laboratory at its Beverly, Mass. location. www.akstonbio.com.