Another Protein Subunit COVID-19 Vaccine Candidate Found Effective
Massachusetts-based Akston Biosciences Corporation announced positive results from a 60-subject, open-label, Phase I trial of AKS-452, its protein subunit, room temperature stable, COVID-19 vaccine candidate.
The vaccine candidate was generally well-tolerated and produced a 100% conversion rate in the 90 micrograms single-dose regimen, as well as the 45 and 90 microgram two-dose regimens.
“The results are very encouraging, showing limited side-effects, comparable to current registered anti-COVID-19 vaccines, overall dosing-cohorts,” said Schelto Kruijff, M.D. Ph.D., the trial’s principal investigator at the UMCG, in a press release.
“It showed a dose-dependent increase in Anti-Spike Protein Receptor Binding Domain (RBD) titers with remarkably high seroconversion rates.”
With both one- and two-dose regimens, a Phase II trial is planned to start at the University Medical Center Groningen, one of the largest hospitals in the Netherlands.
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 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.
Akston's COVID-19 vaccine has been engineered to use standard, low-cost antigen manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year.
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.
Note: Novavax COVID-19 vaccine (NVX-CoV2373) is another prefusion protein coronavirus vaccine candidate.