22 November 2021 - - The first of 100 subjects were dosed in an open-label bridging study of AKS-452, US-based biologic therapeutics developer Akston Biosciences Corp's protein subunit COVID-19 vaccine candidate, in India, the company said.

AKS-452 is shelf stable for at least six months at room temperatures (up to 25° Celsius or 77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit).

India's Drug's Controller General of India, Ministry of Health and Family Welfare, approved the open-label bridging study, being conducted by the Supe Heart and Diabetes Hospital and Research Centre, in Nashik, India along with four other sites in the state of Maharashtra.

Veeda Clinical Research Ltd., a CRO with experience overseeing complex clinical trials, is managing the study.

The open-label bridging study will be conducted with 100 healthy volunteers, age 18 and older. The first participants were dosed under the supervision of principal investigator, Pravin Dinkar Supe, M.D. founder of the Supe Heart and Diabetes Hospital and Research Centre.

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

In both studies, healthy volunteers will receive two 90 µg doses 28 days apart. 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.

The AKS-452 is a protein sub-unit vaccine, a type of vaccine used safely and widely for decades. AKS-452 does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.

Based on Akston's proprietary Fc fusion protein platform, 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 of the novel coronavirus spike protein.

Being the primary locus for infection, the RBD is highly conserved among mutated forms of the virus, and non-clinical testing has demonstrated robust antibody neutralization of SARS-CoV-2 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 bn doses per year.

Akston Biosciences Corp. 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 and Co.), Akston has partnered with Dechra Pharmaceuticals PLC 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. 

Veeda Clinical Research Ltd. is one of the largest independent, full-service clinical research organizations, by revenue in India, headquartered in Ahmedabad, India. Veeda offers a range of bioequivalence studies and early and late phase clinical trials.

Veeda has completed several regulatory inspections and is approved by USFDA, UK MHRA, ANVISA (Brazil), and WHO. Veeda has experience in conducting complex clinical studies.