Biolexis, a division of Stelis Biopharma, and Akston Biosciences have inked a licensing, manufacturing and commercialisation agreement regarding a COVID-19 vaccine.
In a joint statement, the two companies said they will collaborate for the production and sales of Akston’s AKS-452, a protein subunit COVID-19 vaccine.
Under the agreement, Biolexis gained the right to manufacture and commercialise 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.
Last year, the board of Strides Pharma Science had approved the demerger of its biotech business under Stelis Biopharma.
“We are very excited to partner with Akston on AmbiVax-CTM, which is a first-of-its-kind COVID-19 vaccine developed for all parts of the world.
“While the vaccine has demonstrated good outcomes with its safety profile and over 90 per cent 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,” Strides Group Founder Arun Kumar noted.
As AmbiVax-CTM expects to receive emergency use authorization (EUA) as a prime vaccine in H1 of 2022, the company will leverage its group capabilities to manufacture, fill-finish, and commercialise it across all the markets, he added.
“We also remain on course to get the vaccine qualified as a booster to itself and other approved vaccines in different regions,” Kumar stated.
AmbiVax-CTM has completed Phase I and II studies at the University Medical Center Groningen (UMCG) in the Netherlands.
An EUA determining Phase II/III clinical trial is currently underway in India for over 1,600 subjects.
Approval from the Subject Expert Committee (SEC) on vaccines of the Central Drugs Standard Control Organisation (CDSCO) 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 first half of 2022.
Besides this, additional studies are also being pursued to qualify AmbiVax-CTM as a booster to itself or other approved vaccines.
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