Today, TRACER Europe B.V. (“TRACER”), a Clinical Research Organization (CRO) specializing in fast-track solutions for testing innovative biologic medicines, announced that it will support Akston Biosciences Inc. (“Akston”), a leader in the development of novel Fc fusion protein therapeutics, in the Phase 1 clinical testing in the Netherlands of Akston’s lead COVID-19 vaccine candidate, AKS-452. TRACER will provide regulatory services, oversight of local manufacturing contractors as well as Phase 1 Study preparation and clinical site management.
AKS-452 is a novel, biologically engineered SARS-CoV-2-RBD-Fc fusion protein designed to induce and/or augment antibody titers in patients against 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. For example, AKS-452 is designed to be more potent and more easily manufactured with a single batch expected to produce hundreds of millions of doses. AKS-452 is complemented by Akston’s in vitro diagnostic, the AntiCoV-IDTM IgG ELISA kit, which can quantify the levels of neutralizing anti-SARS-CoV-2 antibodies in patient serum samples.
Go van Dam, CEO of TRACER, emphasized, “At TRACER we fully understand the urgency for a fast-track development and clinical evaluation of innovative SARS-CoV-2 vaccines. We are highly motivated to support the Akston team to move AKS-452 rapidly into the clinic to test its safety and efficacy.”
Todd Zion, CEO of Akston Biosciences, added, “Akston pivoted quickly at the start of the pandemic to design a novel vaccine against the SARS-CoV-2 virus using our Fc fusion protein platform. We’re pleased that TRACER will play a critical role in advancing our lead vaccine candidate through initial clinical trials with a shared sense of urgency and innovation.”
About Akston Biosciences
Akston Biosciences leverages its core expertise of designing novel fusion proteins to develop and manufacture new classes of biologic therapeutics for autoimmune Type 1 diabetes (T1D) prevention, ultra-long acting insulin therapy, and vaccines. These are intended to dramatically improve both human and animal health. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co. in 2010), Akston has raised over $13 million in equity financing from the management team and private investors, as well as $10 million from grants and charitable sources. Akston is partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize a once-a-week canine insulin therapy. For more about the company, visit www.akstonbio.com.
About TRACER Europe B.V.
TRACER Europe B.V. is a Clinical Research Organization (CRO) specializing in fast-track solutions for the clinical testing of innovative biologic therapies as well as advanced nuclear and optical molecular imaging methodologies. TRACER and its collaborators provide its clients with the expertise, infrastructure and capacity to rapidly generate first-in-human clinical data. This provides the fastest in-human accurate data on whether the tested compound reaches the target tissue, making clinical trials more cost efficient and products reach the market faster. For more information about TRACER contact or visit www.tracercro.com