AstraZeneca Initiates Phase I Trial of AZD7442 Antibody Cocktail for Prevention and Treatment of COVID-19 Amid Global Surge to Over 24 Million Cases

August 26, 2020 News /Bio ValleyBIOON/ -- At present, the COVID-19 pandemic continues to spread rapidly worldwide. According to Baidu's "Real-time Updates on the Novel Coronavirus Pneumonia Epidemic"Big DataReport, as of 15:00 on August 26, 2020, the global cumulativeOver 24.06 million confirmed cases，Over 823,000 deaths。

Recently,AstraZeneca(AstraZeneca) announced the evaluation of its investigational COVID-19Antibody Cocktail Therapy AZD7442Phase IClinical Trial(NCT04507256) Dosing has been administered to the first cohort of subjects. This is a first-in-human, randomized, double-blind, placebo-controlled, dose-escalating Phase I trial, funded by the U.S. Defense Advanced Research Projects Agency (DARPA) and the U.S. Biomedical Advanced Research and Development Authority (BARDA). The trial will be conducted in 48 healthy subjects aged 18–55 years in the United Kingdom, aiming to evaluate the safety, tolerability, and pharmacokinetics of AZD7442. Data are expected to be released in the second half of 2020.

AZD7442 is an antibody cocktail therapy for the prevention and treatment of COVID-19, composed of two monoclonal antibodies derived from convalescent patients with SARS-CoV-2 infection. These two monoclonal antibodies were discovered by the Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.AstraZeneca optimized these two monoclonal antibodies to extend their half-life and reduce Fc receptor binding.

Half-life-extended monoclonal antibodies should be able toProvides at least 6 months of protection against COVID-19In a study recently published in Nature, these two monoclonal antibodies were clinically demonstrated to block the binding of SARS-CoV-2 to host cells and provide protection against infection in both cellular and animal disease models.

If AZD7742 is proven to be tolerable and have a favorable safety profile in the trial, AstraZeneca will proceed to larger-scale Phase II and Phase III trials.Clinical Trial, to evaluate the efficacy of AZD7742 as a potential therapy for the prevention and treatment of COVID-19.

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated: “This trial represents a significant milestone in our development of a monoclonal antibody combination for the prevention or treatment of COVID-19. This antibody combination, coupled with our proprietary half-life extension technology, not only reduces the potential for viral resistance but also has the potential to enhance efficacy and durability.”

In addition to AstraZeneca, Regeneron is also developing aREGN-COV2, a COVID-19 Antibody Cocktail TherapyThis therapy consists of two monoclonal antibodies that target two distinct, non-overlapping sites within the receptor-binding domain of the SARS-CoV-2 spike protein. These antibodies act synergistically to reduce the risk of viral escape due to mutations. Data from non-human primate studies demonstrate that REGN-COV2 can prevent SARS-CoV-2 infection and treat infected animals by accelerating viral clearance.

REGN-COV2 was developed for the treatment and prevention of COVID-19 infection.Currently, two Phase II/III clinical trials are evaluating treatments for COVID-19, one Phase IIIClinical TrialEvaluating household contact prophylaxis for COVID-19 in infected individuals.

In mid-June, Roche and Regeneron reached a collaboration to jointly develop, manufacture, and distribute REGN-COV2 globally. This therapy is expected to provide a much-needed treatment option for patients who have already developed symptoms of COVID-19, and has the potential to prevent infection in high-risk individuals who have been exposed to the virus, thereby slowing the spread of the global pandemic.

According to the released joint statement, the two parties will increase the supply capacity of REGN-COV2 by at least 3.5-fold from its current level, with potential for further expansion. This will significantly increase the number of doses available to people in the United States and around the world. (Bioon.com)

Original Source: Phase I Clinical Trial Initiated for Monoclonal Antibody Combination for the Prevention and Treatment of COVID-19