Akston Biosciences has dosed the first subjects in a Phase II open-label clinical trial of its protein subunit Covid-19 vaccine candidate, AKS-452.

AKS-452 is based on the company’s Fc fusion protein platform and stimulates a Th1/Th2 mixed immune response against the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein.

Performed at University Medical Center Groningen (UMCG) in the Netherlands and managed by contract research organisation TRACER Europe, the Phase II trial will enrol 52 subjects.

The participants in the trial will be administered either a single 90μg or two 45μg doses of the vaccine 28 days apart.

Data readout from the trial is anticipated in the third quarter of this year, Akston noted.

In a Phase I trial, AKS-452 was demonstrated to be safe and well-tolerated.

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Furthermore, the vaccine generated a complete seroconversion rate in both the 90μg single-dose and 45μg two-dose regimens.

Mild adverse events reported in the trial were comparable to existing registered vaccines.

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

The company noted that the AKS-452 vaccine is shelf-stable for a minimum of six months at 25°C and remains potent for a month at 37°C.

Trial principal investigator Schelto Kruijff said: “From Phase I, we know the AKS-452 showed limited side-effects, comparable to the current registered anti-Covid-19 vaccines.

“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.”

AKS-452 is designed to leverage conventional, cost-effective antibody production methods so that a single manufacturing line can generate more than one billion doses annually.