To manufacture and commercialise an antibody treatment based on ADG20 for India and select emerging markets.
Biocon Biologics announced that the US-based Adagio Therapeutics has granted an exclusive license to Biocon Biologics to manufacture and commercialise an antibody treatment based on ADG20 for India and select emerging markets.
ADG20, a novel monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is in global clinical development by Adagio as a single agent for both the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 virus, its variants, as well as future variants that may emerge.
Initial data indicate that ADG20, Adagio’s lead clinical development candidate, could provide both rapid and durable protection against COVID-19 for up to one year. This could make it an ideal agent to prevent infections and significantly reduce COVID-19 related hospitalisations and death.
With its potential to address resistant variants, including the Delta variant, and its ability to be administered easily as a single, intramuscular injection in the outpatient setting, ADG20 is uniquely poised to address the current need for an effective, safe and convenient therapy for COVID-19.
Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics, said: “We are proud to partner with Adagio in our shared mission to provide affordable access to a best-in-class antibody therapy for people affected by SARS-CoV-2. This partnership with Adagio aligns our joint vision of bringing superior biologic therapies to millions of patients in low and middle-income countries. Vaccines alone will not protect and make the world safer. Biologic therapies that arrest the virus in its path of devastation are a necessity for sustainable protection and safety.”
Adagio has published preliminary data from its ongoing Phase 1 trial in healthy volunteers, which support ADG20’s safety and pharmacokinetic profile and SARS-CoV-2 neutralising activity. Adagio is currently conducting two global Phase 2/3 clinical trials, which will support an Emergency Use Authorization (EUA) submission in the U.S.
Adagio plans to seek Emergency Use Authorization in the US as early as the first quarter of 2022. Under the terms of the deal, Biocon Biologics will get access to the clinical and non-clinical data from Adagio’s EUA submission to the US Food and Drug Administration to seek approvals in the emerging markets.
