Veeda Clinical Research managed Phase II/III trial
Biolexis, the vaccine and biosimilar arm of the Strides Group, is 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.
Akston Biosciences Corporation, also a Strides company, and Biolexis, will submit results from a Phase II/III clinical trial in India of the SARS-CoV-2 vaccine, AKS-452, for Emergency Use Authorization (EUA).
The Phase II/III trial was managed by Ahmedabad-based Veeda Clinical Research Limited and covered 1,600 healthy volunteers – 100 in an open-label bridging study and 1,500 in Phase II/III, double-blind, placebo-controlled trial.
Arun Kumar, Founder of Strides Group, remarked, “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.”
Todd Zion, Ph.D., President & CEO of Akston Biosciences, elaborated on 24 June 2022, “The latest clinical data demonstrate the potential of this low-cost protein vaccine intended specifically for those most in need.
“We are very pleased to be working closely with Biolexis and Strides Group, which can supply the vaccine at scale to countries that need a practical and affordable way to protect their populations during this worldwide pandemic.”
Akston and Strides group have already signed a licensing, manufacturing and commercialization agreement with Biolexis to launch the vaccine worldwide as AmbiVax-CTM. fiinews.com
