The US-based Adagio Therapeutics has granted an exclusive licence to Biocon Biologics to manufacture and commercialise an antibody treatment based on ADG20 for India and select emerging markets, Biocon said in a statement.
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 statement added.
According to the statement, the initial data indicate that ADG20 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 poised to address the current need for an effective, safe and convenient therapy for COVID-19, the statement added.
Speaking on the development, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics, said, “We are proud to partner with Adagio in our shared mission to provide affordable access to the 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.”
The statement also said that the clinical development programme for ADG20 includes three trials:
• The ongoing Phase 1 clinical trial of ADG20 (started in February 2021) to assess safety, tolerability and pharmacokinetics of ADG20 in healthy volunteers.
• The ongoing Phase 2 / 3, STAMP Trial (started in April 2021) to evaluate ADG20 as a treatment for high-risk individuals with mild or moderate COVID-19.
• The ongoing Phase 2/3 pivotal EVADE trial (started in May 2021) to evaluate ADG20 for the prevention of COVID-19.