Akston Biosciences, a developer of new classes of biologic therapeutics, and Biolexis, a division of Stelis Biopharma, 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-C) 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.

AKS-452 or AmbiVax-C is a first-of-its-kind thermostable COVID-19 vaccine developed for all parts of the world. AmbiVax-C 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. The studies on AmbiVax-C 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-C 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-C is a two-shot vaccine injected over 28 days, with the first shot being supported by an adjuvant. The stability studies conducted on AmbiVax-C 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-C has the potential to eliminate challenges in maintaining the cold chain, especially in low-and-middle-income countries where a significant population lacks dependable access to vaccines as a result of insufficient infrastructure to support the cold chain requirements of mRNA COVID-19 vaccines. AmbiVax-C would offer a flexible, reliable, and economically viable vaccine alternative in these regions, allowing the acceleration of immunization and longevity of immunity with the booster shots.

“We are very excited to partner with Akston on AmbiVax-C, which is a first-of-its-kind COVID-19 vaccine developed for all parts of the world,” said Arun Kumar, founder, Strides Group. “While the vaccine has demonstrated good outcomes with its safety profile and over 90% seroconversion in clinical and bridging studies, its room temperature stability offers a unique value to the global population, making it more accessible across the World. As AmbiVax-C expects to receive EUA as a prime vaccine in H1 of 2022, we will leverage our group capabilities to manufacture, fill-finish, and commercialize AmbiVax-C across all the markets. We also remain on course to get the vaccine qualified as a booster to itself and other approved vaccines in different regions.”

Todd Zion, president and CEO, Akston Biosciences, said, “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-C 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 for 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-C as a booster to itself or other approved vaccines.