Type: Combination therapy for preventing and treating COVID-19, consisting of two monoclonal antibodies derived from convalescent patients with SARS-CoV-2 infection, AZD8895 and AZD1061. Both were discovered at Vanderbilt University Medical Center (VUMC)’s Vanderbilt Vaccine Center. The coronavirus-neutralizing antibodies were developed through the company’s program to use the Defense Advances Research Project Agency’s Pandemic Prevention Platform (P3).
Status: AstraZeneca on October 9 was awarded $486 million toward two Phase III trials and related development activities related to AZD7442, including a large-scale manufacturing demonstration project and supply of doses in the U.S. The company estimated that 100,000 doses of AZD 7442 could be available from the project for high-risk patients unable to benefit from a vaccine by December 2020.
One Phase III trial will assess the safety and efficacy of the antibody combination to prevent infection for up to 12 months in approximately 5,000 volunteers. An additional Phase III study will evaluate if AZD7442 can help prevent infection in people who have come in contact with someone with COVID-19 in a post-exposure prophylaxis setting. That study will enroll approximately 1,100 volunteers.
The funding comes through Operation Warp Speed, the Trump administration’s program designed to accelerate the development, manufacturing, and distribution of COVID-19 diagnostics, drugs, and 300 million doses of vaccines. AstraZeneca’s Warp Speed funding comes from the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command.
In August, AstraZeneca began human clinical testing of AZD7442 in a Phase I trial (NCT04507256). The first-in-humans dose escalation study is designed to assess the antibody combination in up to 48 healthy participants in the U.K., ages 18–55 for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs).
After licensing the combination from VUMC in June through an agreement of undisclosed value, AstraZeneca optimized the antibodies with half-life extension and reduced Fc receptor binding. The half-life extended monoclonal antibodies should afford at least six months of protection from COVID-19, according to AstraZeneca.
The Biomedical Advanced Research and Development Authority (BARDA) said June 9 it will award AstraZeneca $23.65 million and join the Defense Advanced Research Projects Agency (DARPA) within the Department of Defense in partnering with the company to advance its monoclonal antibody combination therapy for the treatment and protection against COVID-19 into Phase I clinical development. The agencies also agreed to work with AstraZeneca to manufacture the antibodies for Phase I testing.
In April, AstraZeneca said it is exploring three potential sources for antibodies against SARS CoV-2: Patients who have recovered from COVID-19, immunized humanized mice, and lab techniques such as phage display.
AstraZeneca also disclosed collaborations with external partners: The Chinese Academy of Sciences, and VUMC have provided genetic sequences for antibodies they have discovered against SARS2-CoV-2 for further in silico and in vitro assessment, while the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the University of Maryland School of Medicine are conducting preclinical safety and efficacy assessments of antibody candidates discovered through internal research.
The company said March 24 it will donate 9 million face masks for healthcare workers worldwide, with Italy receiving the first shipments.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: