This is a novel, biologically engineered SARS-CoV-2-RBD-Fc fusion protein designed to induce and/or augment antibody titers in patients against the receptor binding domain (RBD) of the novel SARS-CoV-2 coronavirus that causes COVID-19. Preclinical animal studies have shown robust, neutralizing antibody production at microgram doses. Akston believes that AKS-452 is the most advanced RBD-Fc fusion protein in commercial development and that the nature of the construct can provide unique advantages compared to the nucleic acid, viral-vectored, and inactivated virus vaccine candidates currently being tested.
- Full Receptor Binding Domain (RBD) presented to immune system
- Glycosylated Fc activates immune system response
- Designed to induce and/or augment antibody titers in patients
- Animal studies show robust, neutralizing antibody production
- Production uses established, high-volume methods
- Intended to be effective at microgram doses
Disease and therapy
Currently, social distancing and the widespread shutdown of human activity are the only tools to prevent the spread of the SARS-CoV-2 virus and thus minimize the impact of the COVID-19 pandemic. The consensus among experts is that a full return to normalcy can only occur once there is a sufficient level of immunity to the virus conferred on a human population. The best way to return to normalcy is to develop a sufficient level of immunity to the virus through vaccination.
Akston has directed significant resources and use of its Fc-fusion platform to develop a group of vaccine candidates to address the COVID-19 pandemic. It has selected AKS-452 as its lead for clinical development. This is a novel, biologically engineered SARS-CoV-2-RBD-Fc fusion protein designed to be an injectable therapy for inducing and/or augmenting antibody titers in patients against the novel SARS-CoV-2 virus. Compared to the nucleic acid, viral-vectored, and inactivated virus vaccine candidates currently being tested, AKS-452 is designed to be more potent and more easily manufactured. For example, a single batch of AKS-452 is expected to produce hundreds of millions of doses.
The vaccine is complemented by Akston’s in vitro diagnostic AntiCoV-IDTM IgG ELISA kit, which can quantify the levels of neutralizing anti-SARS-CoV-2 antibodies in patient serum samples.
Development status and plans
Akston has undertaken an urgent, fast-track development and clinical evaluation of AKS-452. It is using its existing manufacturing facility to produce the drug product needed for GLP safety and toxicology studies and will also use this facility to produce the clinical drug substance. It has partnered with TRACER Europe B.V., which will support a Phase 1 clinical trial in the Netherlands. TRACER will provide regulatory services, oversight of local manufacturing contractors for filling and finishing, as well as study preparation and clinical site management.