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Biocon Biologics to manufacture and commercialise a broadly neutralising antibody for India and select emerging Markets

Antibody treatment based on ADG20 targets the spike protein of SARS-CoV-2 and related coronaviruses

ADG20 is for both the treatment, prevention of Covid-19 caused by the SARS-CoV-2 virus, its variants

Bengaluru, NFAPost: Biocon Biologics Ltd., a fully integrated biosimilars company and a subsidiary of Biocon Ltd, announced that 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.

The COVID-19 pandemic continues to be a major health crisis worldwide, and even with emergency use authorizations for vaccines and antibody-based therapies, there remains a significant need for medications to treat and prevent COVID-19 infection. 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 hospitalizations 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.

Biocon Biologics Ltd, Executive Chairperson Kiran Mazumdar-Shaw said the copany is very proud to partner with Adagio in our shared mission to provide affordable access to 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,” said Kiran Mazumdar-Shaw.

Biocon Biologics has a comprehensive Covid-19 portfolio that addresses the needs of patients at different stages of the disease spectrum — mild, moderate, severe and critical.

During the pandemic in India, over 50,000 patients benefited from its COVID-19 drugs that included Remdesevir, Itolizumab and Cytosorb.
COVID-19 remains a significant global health crisis and has resulted in millions of deaths and
lasting health problems in many survivors. We believe that COVID-19 will become an endemic
disease requiring a variety of effective, safe and convenient treatment and prevention options
for years to come.
Data analysis by The Economist on the level of underreported mortality over the course of
the pandemic up to May 2021 is estimated to be around 10.2m of which most are attributable
to low- and middle-income countries (LMICs).
Adagio’s Antibody Therapy

ADG20 is differentiated from other antibody treatments targeting SARS-CoV-2 as it is able to effectively neutralize a broad range of sarbecoviruses, including SARS-CoV-2 and its emerging variants, with high potency.

Preclinical data generated by Adagio and validated by the University of Oxford in a series of recent Cell manuscripts, show that ADG20 uniquely combines potency, breadth and complete neutralization of SARS-CoV-2 and all currently known variants of concern.

Adagio has also published in vitro and in vivo data in Science on ADG2 (the precursor to ADG20), which demonstrated similar or higher potency against SARSCoV-2 compared to other monoclonal antibodies (mAbs) in clinical development, while retaining broad neutralization potency across the sarbecovirus family.

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 neutralizing 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 U.S. as early as the first quarter of 2022. Under the terms of the deal, Biocon Biologics will get access to the clinical and nonclinical data from Adagio’s EUA submission to the U.S. Food and Drug Administration to seek approvals in the emerging markets.
The financial terms and conditions of the deal are not disclosed.
ADG20: Unique Novel Antibody Treatment
• ADG20 can enable convenient outpatient administration as a single intramuscular
injection for both prevention and treatment of COVID-19.
• ADG20 was designed and engineered to possess high potency and broad
neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses.
• ADG20 has the potential to impact viral replication and subsequent disease through
multiple mechanisms of action.
• ADG20 was engineered to have a long half-life, allowing for immediate and durable
protection against COVID-19 for up to one year.
• Adagio is advancing ADG20 through multiple clinical trials on a global basis.
Clinical Trial Updates for ADG20
The clinical development program for ADG20 includes 3 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.

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