BEVERLY, Mass.--(BUSINESS WIRE)--Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first participants have been dosed in a Phase II open-label trial of AKS-452, its protein subunit COVID-19 vaccine candidate.
Fifty-two volunteers will receive either one- or two-dose regimens as part of the Phase II trial conducted at University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. The trial is managed by TRACER Europe B.V., a Contract Research Organization (CRO) specializing in fast-track clinical trials.
The Phase I trial showed AKS-452 to be safe and well-tolerated. Most importantly, AKS-452 produced a 100% seroconversion rate in the 90 microgram single-dose regimen, as well as in the 45 microgram two-dose regimen.
“From Phase I, we know the AKS-452 showed limited side-effects, comparable to the current registered anti-COVID-19 vaccines,” said Schelto Kruijff, M.D. Ph.D., the trial’s principal investigator at the UMCG. “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 AKS-452 has been shown to be shelf stable for at least six months at 25° Celsius (77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit).
“The extended shelf stability, the clinical data that show a single injection of the 90 microgram dose provides 100% seroconversion at significantly higher titers than confirmed COVID-19-positive convalescent serum samples, and the ease of manufacturing relative to current approved vaccines, indicate that our 2nd generation vaccine has the potential to more easily safeguard the health of populations worldwide against COVID,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences.
Potential volunteers can still sign up to participate in the study and receive the AKS-452, a protein sub-unit vaccine, a type of vaccine used safely for decades, and does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus. All will receive the vaccine and none will receive a placebo. To learn more, click here: https://www.umcg.nl/-/medisch-wetenschappelijk-onderzoek/act-studie.
Gerard Metselaar said he felt lucky to get to participate in Phase I: “I am living proof that this vaccine is effective,” he said. Because of the study, “I was vaccinated way before anyone in my age group. Even though that was a great feeling, I gained most satisfaction from knowing this will help so many other people get closer to their vaccination.”
About the Phase II clinical trial
The Phase I/II clinical trial, an open-label study, evaluates a total of 112 healthy volunteers between the ages of 18 and 85 to determine safety, tolerability, and immune response, participants in Phase II will receive either one dose of 90 micrograms or two doses of 45 micrograms 28 days apart.
Based on Akston’s proprietary Fc fusion protein platform, AKS-452 is a CoV-2 protein subunit vaccine candidate designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. Being the primary locus for infection, the RBD is highly conserved among mutated forms of the virus, and preclinical studies have demonstrated robust antibody neutralization of the Alpha and Beta variants. The vaccine has been engineered to use standard, low-cost, antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year at existing plants around the world.
About Akston Biosciences
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing facility and research laboratory at its Beverly, Mass. location. www.akstonbio.com.
TRACER Europe B.V. (“TRACER”) is a Clinical Research Organization (CRO) specializing in fast-track solutions for testing innovative biologic medicines and is a founding member of the COVID-19 Rapid Cure Task Force (RCTF). TRACER and its partners provide its clients with the expertise, infrastructure, and capacity to rapidly generate accurate first-in-human clinical data. www.tracercro.com.
About University Medical Center Groningen
The University Medical Center Groningen (UMCG) is one of the largest hospitals in the Netherlands. The more than 12,000 employees work together on care, research, training and education with the common goal: building the future of health. Through innovative and sound research UMCG aims to understand mechanisms of disease; to push borders for diagnostics and treatment; and to help build a network for sustainable health. All of its research focuses on Healthy Ageing. Talent development and state-of-the-art infrastructure are of paramount importance to UMCG.