Akston Biosciences Doses First Subjects in Phase II Clinical Trial of Second Generation Protein Subunit COVID-19 Vaccine
Posted on Friday, 06 August 2021 10:07
- First phase II subjects receiving AKS-452, COVID-19 vaccine candidate in a Dutch trial
- New data shows vaccine is stable for at least six months at 25 degrees Celsius (77 Â° Fahrenheit)
- Readings expected in the third quarter of 2021
BEVERLY, MA, USA I August 5, 2021 I Akston Biosciences Corporation, a developer of new classes of biological therapeutics, today announced that the first participants have been assayed in an open-label Phase II trial of AKS-452, its COVID-protein subunit vaccine candidate. 19.
Fifty-two volunteers will receive one- or two-dose regimens as part of the phase II trial at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. The trial is managed by TRACER Europe BV, a contract research organization (CRO) specializing in accelerated 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 single-dose 90 microgram regimen, as well as the two-dose 45 microgram regimen.
“As early as Phase I, we know that AKS-452 has shown limited side effects, comparable to currently registered COVID-19 vaccines,” said Schelto Kruijff, MD Ph.D., principal investigator of the trial. at the UMCG. âNew data that this vaccine candidate is stable at room temperature for at least six months makes it ideal for countries like Malawi and Kenya, where I volunteer, as it can be transported and stored for months without refrigeration. . “
AKS-452 has been shown to be stable for at least six months at 25Â° Celsius (77Â° Fahrenheit) and maintains its potency for a month at 37Â° Celsius (99Â° Fahrenheit).
“Prolonged shelf-life stability, clinical data showing that a single injection of the 90 microgram dose provides 100% seroconversion at significantly higher titers than COVID-19 positive convalescent serum samples, and the ease of manufacture compared to currently approved vaccines, indicate that our 2sd The generational vaccine has the potential to more easily protect the health of populations around the world from COVID, âsaid Todd Zion, Ph.D., president and CEO of Akston Biosciences.
Prospective volunteers can still register to participate in the study and receive AKS-452, a subunit protein vaccine, a type of vaccine that has been used safely for decades, and does not include the technology of the MRNA, viral vectors or a weakened SARS-CoV. -2 viruses. All will receive the vaccine and none will receive a placebo. To find out more, click here: https://www.umcg.nl/-/medisch-wetenschappelijk-onderzoek/act-studie.
Gerard Metselaar said he felt lucky to be able to participate in Phase I: “I am living proof that this vaccine is effective,” he said. Because of the study, âI was vaccinated long before anyone in my age group. Although it was a great feeling, I got the greatest satisfaction knowing that it 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 aged 18 to 85 years to determine safety, tolerability and immune response; Phase II participants will receive either a 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 mixed Th1 / Th2 immune response in patients against the binding domain at the receptor (RBD) of the novel spike protein of the coronavirus. Being the primary locus of infection, RBD is highly conserved among mutated forms of the virus, and preclinical studies have demonstrated robust neutralization of antibodies to the Alpha and Beta variants. The vaccine was designed to use standard, inexpensive antibody manufacturing techniques, so that a single production line could be able to produce over a billion doses per year in existing factories around the world.
About Akston Biosciences
Akston Biosciences Corporation is leveraging its new 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 glucose-reactive clinical insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize drug therapies. canine and feline insulin once a week. . It operates a GMP biologics manufacturing plant and research laboratory at its Beverly, Massachusetts site. www.akstonbio.com.
TRACER Europe BV (âTRACERâ) is a clinical research organization (CRO) specializing in accelerated solutions for testing innovative biologic drugs and is a founding member of the COVID-19 Rapid Cure Task Force (RCTF). TRACER and its partners provide its customers with the expertise, infrastructure and capacity to rapidly generate accurate human clinical data. www.tracercro.com.
About the University Medical Center of 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 a common goal: to build the future of healthcare. Thanks to innovative and solid research, the UMCG aims to understand the mechanisms of the disease; pushing the boundaries of diagnosis and treatment; and to help build a network for sustainable health. All of his research focuses on healthy aging. Talent development and state-of-the-art infrastructure are of paramount importance to UMCG.
THE SOURCE: Akstone Biosciences