Akston, Biolexis complete clinical trials of SARS-CoV-2 vax

Mumbai: Akston Biosciences Corporation and Biolexis, a Strides Group Company, announced results from a phase II/III clinical trial in India of the SARS-CoV-2 vaccine, AKS-452, in which 1,600 healthy volunteers participated in an open-label bridging study and 1,500 in phase II/III, double-blind, placebo-controlled trial. This caused the stock price of the company to surge by 9.7 per cent in Friday's trade, the company said in an exchange filing.

Akston and Strides group have already signed a licensing, manufacturing, and commercialization agreement to launch this vaccine worldwide as AmbiVax-CTM. As per the agreement, Biolexis (The vaccine and biosimilar arm of Strides group) has the right to manufacture and commercialise AmbiVax-CTM in India and over 130 countries in Asia, Latin America, and Africa, mainly covering the low-and-middle-income countries.

Volunteers in the bridging study had antibody titers that persisted at statistically-significant high levels through six months, with serum taken from them showing protection against variants of concern.

Arun Kumar, Founder of Strides Group, added, "We are pleased to know the encouraging results from the India studies of AmbiVax-CTM, particularly the high serocon version rate that the vaccine demonstrated. This vaccine differentiates itself by allowing room-temperature stability, higher efficacy, and safety and can offer accessibility and affordability through the economical supply chain and infrastructure requirements. As we progress to receiving the approval, we will continue exploring opportunities to fast-track its launch for the global markets."