Second COVID-19 Antibody from Vir, GSK Enters Phase 1b Trial

Vir Biotechnology and GSK recently announced an agreement with UK-based AGILE initiative to evaluate the company’s COVID-19 antibody, VIR-7832, in a Phase 1b/2a clinical trial.

The AGILE trial platform will use adaptable protocols and statistical models to evaluate VIR-7832 in patients with mild to moderate COVID-19. The trial is expected to begin in the first quarter of this year. 

The initiative is a collaboration between the University of Liverpool, Liverpool School of Tropical Medicine, Liverpool University Hospitals NHS Foundation of Trust, and University of South Hampton and Lancaster University.

Additionally, AGILE was coordinated by the National Institute of Health Research Southampton Clinical Trials Unit across the UK Clinical Research Facility Network. 

“We are pleased to have the support of the NHS behind our efforts to evaluate and advance VIR-7832 for the treatment and potential prevention of COVID-19,” George Scangos, PhD, chief executive officer at Vir, said in the announcement. 

“This study will be critical to our efforts as we work to understand whether the modifications we have made to this monoclonal antibody increase its potency and stimulate a T cell response to not only provide therapeutic benefits but also potentially confer a vaccine-like effect that could be applicable to prophylaxis,” Scangos continued. 

In previous clinical trials, data has suggested that VIR-7832 has two distinguishing properties, including an enhanced ability to clear infected cells and the potential to enhance virus-specific T-cell function, a Vir spokesperson said. 

These properties could help treat or prevent COVID-19 infection. VIR-7832 is expected to become the second monoclonal antibody from the Vir-GSK collaboration.

At the beginning of April, the companies collaborated to enhance COVID-19 drug discovery through the use of CRISPR, a technology that is used for gene editing, and artificial intelligence. 

The partnership aimed to accelerate the development of specific antibody candidates using Vir’s monoclonal antibody platform technology and GSK’s expertise in functional genomics.  

Vir’s platforms, VIR-7831 and VIR-7832 previously showed a similarity with the SARS-CoV-2 spike protein. Over the past six months, VIR-7831 has shown promise in clinical trials. 

At the beginning of September, GSK and Vir dosed the first patients in a Phase 2/3 study evaluating VIR-7831.

The lead-in phase of COMET-ICE enrolled 20 patients to assess the safety and tolerability of a single 500 milligram intravenous infusion of VIR-7831 or a placebo over a period of 14 days in hospitalized patients.

The COMET-ICE clinical development program for the antibody also includes two additional planned trials for the treatment of severely ill hospitalized patients and for the prophylaxis of symptomatic infection. 

In October, Vir and GSK also announced the global expansion of the Phase 3 trial evaluating VIR-7831 in patients who are at high risk of hospitalization from the coronavirus. 

The global expansion will reach sites in North America, South America, and Europe. 

The Phase 3 portion of COMET-ICE will further uncover the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in 1,300 non-hospitalized participants.

The endpoint will be the number of patients who see a progression of COVID-19, which will be determined by the need for hospitalization or death within 29 days of randomization, GSK said in a September announcement. 

Results for the primary endpoint of the trial are expected early this year.  

“While vaccine development has been very successful, current infection and hospitalisation rates show that multiple vaccines and therapeutic options will be needed to combat and ultimately end this pandemic,” Hal Barron, MD, chief executive officer and president of research and development at GSK, said in the most recent GSK announcement. 

“We are grateful to everyone involved in the AGILE study for supporting this important research and expect initial results from the study to provide important insights into the use of VIR-7832 early in the course of infection with SARS-CoV-2.”