Strides, Akston Biosciences Thermostable 2nd Gen COVID Vaccine trial shows encouraging top-line results

"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," the release stated.

Arun Kumar, Founder of Strides Group, added, "We are pleased to know the encouraging results from the India studies of AmbiVax-C, 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, said, "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."

The Phase II/III trial, managed by Ahmedabad-based Veeda Clinical Research Limited, evaluated the safety, tolerability, and humoral immunogenicity profile, i.e., SP/RBD-specific IgG titers. Of the 1,500 healthy volunteers, 1,125 received the two 90 µg doses 28 days apart, with the first dose including AKS452 and an adjuvant, while the second dose consisted of only AKS-452. The remaining 375 also received two doses, with the first dose including placebo and the adjuvant, while the second dose consisted only of placebo.

AKS-452 does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus. It has been engineered to use established, low-cost antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year. Stability studies have demonstrated thermostability at room temperature for over six months at 25° Celsius (77° Fahrenheit) and maintenance of potency for one month at 37° Celsius (99° Fahrenheit)

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