Akston Biosciences has reported positive data from a Phase I 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.

As the primary site for infection, the RBD is conserved among mutated variants and preclinical studies showed strong antibody neutralisation of the B.1.1.7 (Alpha) and B.1.351 (Gamma) variants.

The vaccine is stable at room temperature for four months at 25°​C.

It is engineered to utilise standard, cost-effective, antibody production methods. This enables one manufacturing line to make more than one billion doses a year.

Data from the open-label Phase I trial in 60 participants revealed that the vaccine was well-tolerated and induced a complete conversion rate in the 90µg single-dose regimen and two-dose regimen consisting of 45 and 90µg doses.

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Furthermore, mild adverse events were observed that are comparable to existing registered vaccines.

Akston Biosciences president and CEO Todd Zion said: “The study confirms the preclinical data that showed AKS-452 is safe, and a single injection of the 90mg dose provides 100% seroconversion, with significantly higher titers than confirmed Covid-19-positive convalescent serum samples.

“This is an important milestone for our programme indicating that it can deliver key benefits to countries that need an affordable and easily transportable vaccine.”

Akston intends to commence a Phase II trial of single-dose and two-dose regimens of the vaccine later this month at the University Medical Center Groningen (UMCG), in the Netherlands.

Contract research organisation TRACER Europe, which focuses on expedited trials, will manage the Phase II trial. Data readout is anticipated in the third quarter of this year.

Earlier this year, Akston dosed the first participant with AKS-452 in a Phase I/II trial in the Netherlands.