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Protein Subunit COVID-19 Vaccine Candidate Seeks Phase 2 Participants

August 6, 2021 • 10:00 am CDT
(Precision Vaccinations)

Massachusetts-based Akston Biosciences Corporation confirmed on August 5, 2021, that the first participants had been dosed in a Phase II open-label trial of AKS-452, its protein subunit COVID-19 vaccine candidate.

The Phase I trial showed AKS-452 produced a 100% seroconversion rate in the 90 micrograms single-dose regimen, as well as in the 45 micrograms two-dose regimen, and was found safe and well-tolerated.

Furthermore, the AKS-452 vaccine candidate has been shown to be shelf-stable for at least six months at 25° Celsius and maintains its potency for one month at 37° Celsius.

Based on Akston’s proprietary Fc fusion protein platform, AKS-452 is a CoV-2 protein subunit vaccine 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 B.1.1.7 and B.1.351 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.

“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, in a press release.

“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."

Potential study volunteers can still sign up to participate in the study and receive the AKS-452, a protein subunit 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. 

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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.