Akston Biosciences Corp., a developer of new classes of biologics, and Biolexis, a division of Stelis Biopharma Ltd., have entered into a licensing, manufacturing and commercialization agreement for Akston’s AKS-452, a protein subunit COVID-19 vaccine. 
 
Biolexis gains the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence and established relationships.
 
AmbiVax-CTM is a first-of-its-kind thermostable COVID-19 vaccine developed for all parts of the world. AmbiVax-CTM is a SARS-CoV-2 protein subunit vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. As the primary locus for infection, the RBD is highly conserved among mutated forms of the virus. Studies on AmbiVax-CTM have demonstrated robust antibody neutralization of variants, including Delta and Omicron, and the vaccine has been evaluated in multiple safety and efficacy studies in Netherlands and India across hundreds of subjects.
 
AmbiVax-CTM does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus and 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. 
 
AmbiVax-CTM is a two-shot vaccine injected over 28 days, with the first shot being supported by an adjuvant. The stability studies conducted on AmbiVax-CTM have demonstrated thermostability at room temperature for over six months at 25° Celsius (77° Fahrenheit) and maintains potency for one month at 37° Celsius (99° Fahrenheit). Being shelf-stable at these temperatures, AmbiVax-CTM has the potential to eliminate challenges in maintaining the cold chain.

AmbiVax-CTM has completed Phase I and II studies at the University Medical Centre Groningen (UMCG) in the Netherlands. The recent Phase II trial data showed a greater than 90% seroconversion rate after two 45 μg doses (100%) or a single 90 μg dose (96%) in healthy adults at 56 days. It was well tolerated with a safety profile comparable to approved vaccines.
 
An EUA determining Phase II/III clinical trial is currently underway in India in over 1,600 subjects. The bridging study of 100 subjects has already been completed with a favorable safety profile and greater than 90% seroconversion achieved on day 28 post two vaccines doses.
 
Approval from the Subject Expert Committee (SEC) on vaccines of the Central Drugs Standard Control Organization (CDSCO), India, has been received to begin the dosing of the remaining 1,500 subjects. The studies are expected to conclude in April 2022 with a potential EUA within the H1 of 2022. Besides this, additional studies are also being pursued to qualify AmbiVax-CTM as a booster to itself or other approved vaccines.