26/07/2021 — WALTHAM, Mass. — (BUSINESS WIRE)
Adagio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced a partnership agreement with Biocon Biologics Ltd., to combat the ongoing COVID-19 crisis in southern Asia. 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.
“This partnership underscores the commitment of two companies to come together in order to make a significant impact on global health,” said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio. “At Adagio, we spent a lot of time engineering a highly differentiated molecule in our global fight against COVID-19, and, from the beginning, our metric of success was focused on how many lives we can touch. We expect this partnership to rank very highly on the ‘lives touched’ scale, which was the driver behind pursuing this agreement. Importantly, Biocon’s extensive manufacturing capabilities will enable large scale production, making this potentially life-saving drug broadly available to millions of people who otherwise would not have access to this type of therapy.”
“Earlier this year, we witnessed one of the worst human tragedies in India and southern Asia as a result of COVID-19,” said Kiran Mazumdar-Shaw, executive chairperson of Biocon. “As a company, it is our belief that the pharmaceuticals industry has a humanitarian responsibility to serve patients who are in need. We had looked at dozens of potential molecules, and upon reviewing the ADG20 data, we were convinced this was a differentiated antibody with the potential to address not only today’s virus and variants, but future SARS-like viruses as well. It has become clear that this virus has endemic potential, and Adagio is the ideal partner to significantly help global efforts to both treat and prevent COVID-19. We aim to move quickly to commercialize an antibody that is effective, safe and, most importantly, affordable to millions of people in need.”
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.
About Adagio Therapeutics
Adagio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The company’s portfolio of antibodies has been optimized using Adimab’s industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio’s portfolio of SARS-CoV-2 antibodies includes multiple, non-competing broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers through the completion of clinical trials and, if approved by regulatory authorities, through initial commercial launch. For more information, please visit www.adagiotx.com.
Dan Budwick, 1AB
Monique Allaire, THRUST Strategic Communications