Biolexis, Akston Announce Encouraging Top-Line Results from Phase II/III Trial of their Thermostable 2nd Gen COVID-19 Vaccine
Biznextindia : Akston Biosciences Corporation and Biolexis, a Strides Group Company, on Friday 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 – 100 in an open-label bridging study and 1,500 in Phase II/III, double-blind, placebo-controlled trial.
An interim analysis of this data shows no significant safety issues and a 91% seroconversion rate at Day 56. 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. The results will be submitted as a prime vaccine in India for Emergency Use Authorization (EUA). Later clinical studies are planned to support approval for use as a booster shot to itself and other approved vaccines. Earlier studies in the Netherlands have demonstrated robust antibody neutralization of variants, including Delta and Omicron.
Akston and Strides group have already signed a licensing, manufacturing, and commercialization agreement to launch this vaccine worldwide as AmbiVax-CTM. Under the agreement, Biolexis (The vaccine and biosimilar arm of Strides group) has the right to manufacture and commercialize AmbiVax-CTM in India and over 130 countries in Asia, Latin America, and Africa, mainly covering the low-and-middle-income countries (LMICs) where a significant population lacks dependable access to vaccines as a result of insufficient infrastructure to support the cold chain requirements of other COVID-19 vaccines. The vaccine is a reliable, accessible alternative in these regions, allowing immunization and longevity of immunity with the boosters against the Covid variants of concern. The partnership will leverage the capabilities of Strides Group, which has an “in Africa for Africa” strategy and will offer the vaccine to countries with a deep market presence and established relationships.
“We are pleased to know the encouraging results from the India studies of AmbiVax-CTM, particularly the high seroconversion 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” Arun Kumar, Founder of Strides Group, said.