Therapy Areas: Vaccines
Akston Biosciences announces Phase I/II clinical trial of COVID-19 vaccine candidate
12 April 2021 -

Biologic therapeutics company Akston Biosciences Corporation disclosed on Monday that it has commenced a Phase I/II clinical trial, an open-label study, of its COVID-19 vaccine candidate AKS-452.

Akston Biosciences said the first participants have been dosed in the trial, which is managed by TRACER Europe B.V, a CRO specializing in fast-track clinical trials. The trial is being conducted at the University Medical Center Groningen (UMCG), a large hospital in the Netherlands.

The company added that the trial will evaluate 176 healthy volunteers between the ages of 18 and 65. Trial participants will receive one dose or two doses 28 days apart and the protocol will assess three-dose levels (22.5, 45, and 90 micrograms) to determine safety, tolerability and immune response.

According to Akston Biosciences, AKS-452 has demonstrated robust protection against infection in immunised non-human primates after challenge with the SARS-CoV-2 virus. The vaccine candidate is intended to be refrigerated for long-term storage, but has been shown to be shelf-stable for at least four months at 25 degrees Celsius (77° Fahrenheit) and maintains its potency for one month at 37 degrees Celsius (95° Fahrenheit).

AKS-452 is based on Akston's proprietary Fc fusion protein platform and is a CoV-2 subunit vaccine designed to induce or boost a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein.