Policy & Regulation
Adagio Therapeutics Partners with Biocon Biologics to Bring COVID-19 Antibody Treatment to Patients in India and Select Emerging Markets
27 July 2021 - - US-based biopharmaceutical company Adagio Therapeutics, Inc has inked a partnership agreement with Indian biosimilars specialist Biocon Biologics Ltd., to combat the ongoing COVID-19 crisis in southern Asia, the company said.

Biocon Biologics Ltd. is a fully integrated biosimilars company and a subsidiary of Biocon Ltd., a global biopharmaceuticals company, (BSE code: 532523) (NSE: BIOCON).

Under the terms of the agreement, Adagio will provide Biocon with materials and know-how to manufacture and commercialize an antibody treatment based on ADG20 in India and additional select emerging markets.

ADG20, Adagio's lead product candidate, is designed to be a potent, long-acting and broadly neutralizing antibody for both the treatment and prevention of COVID-19 as either a single or combination agent.

Unlike other antibody-based therapies specifically targeting SARS-CoV-2, ADG20 has demonstrated an ability to neutralize SARS-CoV-2 in non-clinical studies, including variants of concern, as well as a broad range of other SARS-like viruses.

ADG20 is currently being evaluated in two separate Phase 2/3 global clinical trials, the STAMP trial to evaluate ADG20 for the treatment of non-hospitalized COVID-19 patients and the EVADE trial to evaluate ADG20 for the prevention of COVID-19.

The partnership provides Biocon rights to manufacture and commercialize an antibody treatment in India and additional select emerging markets based on the commercial process developed for ADG20.

As part of the agreement, Biocon will be granted access to the data from Adagio's ongoing Phase 2/3 ADG20 clinical trials and access to its anticipated Emergency Use Authorization package, as well as regulatory submissions, to support approval or emergency authorization in India and other select emerging markets.

Financial details of the agreement are not disclosed.

ADG20, a monoclonal antibody targeting SARS-CoV-2 and related coronaviruses, is being developed for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2.

ADG20 was designed to be a potent, long-lasting and broadly neutralizing antibody for both treatment and prevention against SARS-CoV-2 and additional clade 1 sarbecoviruses by targeting a highly conserved epitope in the receptor binding domain.

In preclinical studies, ADG20 demonstrated broad neutralizing activity against the original SARS-CoV-2 strain as well as known variants of concern.

ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity.

ADG20 is formulated at a high concentration, enabling intramuscular administration, and was engineered to have a long half-life, with a goal of providing both rapid and durable protection.

Adagio is advancing ADG20 through multiple clinical trials on a global basis.