Akston Biosciences has initiated dosing of the first subjects in a Phase II open-label trial of AKS-452, its protein subunit Covid-19 vaccine candidate.
This vaccine candidate is based on the company’s Fc fusion protein platform.
It stimulates a Th1/Th2 mixed immune response against the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein.
The Phase II trial will see participation of 52 subjects, and is carried out at University Medical Center Groningen (UMCG) in the Netherlands and managed by contract research organisation TRACER Europe.
The subjects will be given either a single 90μg or two 45μg doses of the vaccine 28 days apart.
Akston expects the data readout from the study in Q3 2021.
During the Phase I trial, AKS-452 was found to be safe and well-tolerated.
This vaccine also generated a full seroconversion rate in the 90μg single-dose as well as the 45μg two-dose regimens.
The trial reported mild adverse events that were comparable to current 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 trial’s 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.”
The firm also stated that the AKS-452 vaccine is shelf-stable for a minimum of six months at 25°C.
The vaccine is also claimed to remain potent for a month at 37°C.