2nd Generation COVID-19 Vaccine Available in 130+ Countries
Massachusetts-based Akston Biosciences Corporation and Biolexis announced today that they have entered into a licensing, manufacturing, and commercialization agreement for Akston's AKS-452, a protein subunit COVID-19 vaccine.
Under the agreement, 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.
Approval from the Subject Expert Committee on vaccines of the Central Drugs Standard Control Organization, India, has been received to begin the dosing of 1,500 subjects. The studies are expected to conclude in April 2022 with a potential authorization within the H1 of 2022.
Besides this study in India, additional studies are also being pursued to qualify AmbiVax-CTM as a booster to itself or other approved vaccines.
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 virus forms.
The 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 the Netherlands and India across hundreds of subjects.
AmbiVax-CTM does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.
Commenting on the partnership, Todd Zion, Ph.D., President & CEO of Akston Biosciences, said in a press release issued on March 17, 2022, "We are very pleased to be working closely with Biolexis and Strides Group, which has the experience, know-how, and capability to produce our vaccine at scale."
"Just as importantly, the group can supply the vaccine to countries that need a practical and affordable way to protect their populations during this worldwide pandemic."
AmbiVax-CTM completed Phase I and II studies at the University Medical Centre Groningen 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.
Note: This press release was edited for clarity and curated for mobile readers.