Akston Biosciences Doses First Participants in Phase II Clinical Trial for Shelf-Stable COVID-19 Booster
- Up to 600 volunteers will participate in an AKS-452 COVID booster study in the Netherlands to investigate boosting the immune response of those previously vaccinated with EMA-registered vaccines
- AKS-452 has shown the ability to successfully neutralize the omicron variant of the SARS-CoV-2 virus
- Shelf stable at 25° Celsius (77° Fahrenheit) for at least 6 months, the low-cost SARS-CoV-2 vaccine can be efficiently manufactured anywhere in the world using standard antibody production facilities
- AKS-452 is currently undergoing Phase II/III clinical testing in India as a primary vaccine; submission for Emergency Use Authorization (EUA) expected by Q3 2022.
Excerpt from the Press Release:
BEVERLY, Mass.–(BUSINESS WIRE)–Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today it dosed the first set of volunteers in an open-label study of AKS-452, its protein subunit COVID-19 vaccine, as a booster. The Phase II booster study is designed to investigate the response of the immune system in up to 600 volunteers who have previously been vaccinated with EMA-registered vaccines from Pfizer, Moderna, Johnson & Johnson (Janssen) and AstraZeneca.
The study is being conducted at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. Schelto Kruijff, M.D., Ph.D., the principal investigator at the UMCG for the AKS-452 Phase I and Phase II primary vaccine trials, is serving in the same capacity for the booster trial.
“AKS-452 induced a Th1/Th2 mixed immune response against the Receptor Binding Domain (RBD) of the coronavirus spike protein, according to an analysis of the Phase II study of AKS-452 as a primary vaccine,” Dr. Kruijff said. “While we still need to vaccinate millions of people with a primary COVID-19 shot, it’s also clear that we’ll need an annual booster shot, and key characteristics of AKS-452, including low price and shelf stability, could make AKS-452 an ideal solution.”
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