Akston Bio starts Phase II trials of Covid vax

Our Bureau | Updated on: Nov 22, 2021
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100 volunteers will participate in AKS-452 study; readouts expected January 2022

Ahmedabad, November 22

US-based Akston Biosciences Corporation, on Monday, administered doses to the first of 100 subjects in an open-label bridging study of AKS-452, its protein subunit Covid vaccine candidate, in India.

DCGI approval

The regulator, Drugs Controller General of India (DCGI), had approved the open-label bridging study, being conducted by the Supe Heart & Diabetes Hospital and Research Centre, in Nashik, India, along with four other sites in Maharashtra, said a statement from the company.

Ahmedabad-based Veeda Clinical Research Ltd, a CRO with expertise in complex clinical trials, is managing the study.

The open-label bridging study will be conducted with 100 healthy volunteers aged 18 and older.

The first participants were given the doses under the supervision of principal investigator, Pravin Dinkar Supe, founder of the Supe Heart & Diabetes Hospital and Research Centre, said the statement. The readouts are expected in January 2022

A double-blind Phase II/III study will follow with 1,500 healthy volunteers, aged 18 and older, across 12 clinical sites in five States across India.

In both studies, healthy volunteers will receive two 90 micro-gram doses 28 days apart.

Trial participants

Of the 1,500 participants in the Phase II/III study, 1,150 will receive the two-dose regimen, while the remaining 350 will receive two placebo doses.

The first dose will include AKS-452 and an adjuvant, which primes the body’s immune response, with the second dose consisting only of AKS-452.

AKS-452 is shelf stable for at least six months at room temperatures (up to 25 degrees-Celsius or 77 degrees Fahrenheit) and maintains its potency for one month at 37-degrees Celsius (99-degrees Fahrenheit). “The highly promising results from a previous Phase II trial in the Netherlands warrant moving forward with an open-label bridging study and the Phase II/III clinical trial here in India to help speed a low-cost, temperature-resistant vaccine that can be easily manufactured, transported and stored in economically deprived countries in Africa and Asia,” said Supe.

“As a second-generation vaccine, AKS-452 has the potential to more easily safeguard the health of populations worldwide against Covid. Using our proprietary Fc fusion protein platform, AKS-452 is designed to be well tolerated for primary vaccination and boosting when immunity wanes,” said Todd Zion, President & CEO of Akston Biosciences. AKS-452, a protein sub-unit vaccine, is used safely and widely for decades. It does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus. AKS-452 is a SARS-CoV-2 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.

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, said the statement.

Published on November 22, 2021

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