Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced that the first participants have been dosed in a Phase II open-label trial of AKS-452, its protein subunit COVID-19 vaccine candidate. 

Fifty-two volunteers will receive either one- or two-dose regimens as part of the Phase II trial conducted at University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. The trial is managed by TRACER Europe B.V., a Contract Research Organization (CRO) specializing in fast-track clinical trials.

The Phase I trial showed AKS-452 to be safe and well-tolerated. Most importantly, AKS-452 produced a 100% seroconversion rate in the 90 microgram single-dose regimen, as well as in the 45 microgram two-dose regimen.

“From Phase I, we know the AKS-452 showed limited side-effects, comparable to the current registered anti-COVID-19 vaccines,” said Schelto Kruijff, M.D. Ph.D., the trial’s principal investigator at the UMCG. “The new data that this vaccine candidate is shelf-stable at room temperature for at least six months makes it ideal for countries such as Malawi and Kenya, where I volunteer because it can be transported and stored for months without refrigeration.”

The AKS-452 has been shown to be shelf-stable for at least six months at 25° Celsius (77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit).

“The extended shelf stability, the clinical data that show a single injection of the 90 microgram dose provides 100% seroconversion at significantly higher titers than confirmed COVID-19-positive convalescent serum samples, and the ease of manufacturing relative to current approved vaccines, indicate that our 2 nd generation vaccine has the potential to more easily safeguard the health of populations worldwide against COVID,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. 

Potential volunteers can still sign up to participate in the study and receive the AKS-452, a protein sub-unit vaccine, a type of vaccine used safely for decades, and does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus. All will receive the vaccine and none will receive a placebo.