Bengaluru-headquartered Biocon Biologics has partnered US-based Adagio Therapeutics for an exclusive licence to manufacture and commercialise an advanced antibody treatment against Covid-19 for India and select markets.
The antibody treatment is based on ADG20, a novel monoclonal antibody, which targets the spike protein of SARS-CoV-2 and related coronaviruses. It is under clinical development by Adagio as a potential single agent for both the treatment and prevention of Covid-19, a press statement said.
“Vaccines alone will not protect and make the world safer. Biologic therapies that arrest the virus on its path of devastation are a necessity for sustainable protection and safety,” said Kiran Mazumdar-Shaw, executive chairperson, Biocon Biologics.
Data indicate that this antibody treatment candidate can provide rapid and durable protection against Covid-19 for up to one year.
This monoclonal antibody can be administered as a single, intramuscular injection in the outpatient setting and claims to have the potential to address resistant variants, including the Delta variant. Used to treat only mild-to-moderate disease in high-risk Covid-19 patients, doctors feel the antibody cocktail treatment can bolster the fight against severe cases of the virus.
Adagio plans to seek Emergency Use Authorisation (EUA) in the US by the first quarter of 2022. Under the terms of the deal, Biocon will get access to clinical and non-clinical data from Adagio’s EUA submission to the US Food and Drug Administration, in order to seek approval in emerging markets.
The firm’s statement added that pre-clinical data generated by Adagio and validated by the University of Oxford, show that ADG20 combines potency, breadth, and complete neutralisation of SARS-CoV-2 and all currently known variants of concern.
The monoclonal antibody cocktail treatment had picked up in India after Roche India received the Emergency Use Authorisation (EUA) for importing the globally manufactured product last month. The cocktail was successfully administered to former US President Donald Trump and has found positive results in Indian patients as well.
The drug is to be administered for the treatment of mild-to-moderate coronavirus disease in adults and paediatric patients who are aged 12 years or older, and who weigh at least 40 kg. They must have a high risk of developing severe Covid-19 and should not require oxygen at that stage of administration.
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