US-based Vir Biotech has plans to begin a mid-to-late stage study of its COVID-19 drug this month, following promising results in early studies.
The candidate, VIR-7832, is a monoclonal antibody that has demonstrated the ability to neutralise the SARS-CoV-2 virus, which causes COVID-19, in vitro. The drug has also demonstrated a high barrier to resistance and an ability to recruit immune cells to kill already infected cells.
Based on these characteristics, Vir hopes that the drug can achieved clinical efficacy in large-scale human trials. Following the initiation of trials this month, the company hopes to have initial clinical data available before the end of the year.
The clinical programme for VIR-7831 includes trials for early and hospitalised treatment of COVID-19 patients, as well as a prevention medication.
In May, Vir signed a deal with Biogen to develop and manufacture antibodies for the potential treatment of COVID-19. This included VIR-7831 and another antibody candidate, VIR-7832.
Under the terms of this agreement, Biogen will perform process development activities and specified manufacturing/process transfer services to enable commercial supply of Vir’s antibody treatments.
“Biogen’s world-class cell line and process development expertise is a tremendous asset as we work with great urgency to develop our antibody candidates, including employing technology that is designed to maximise the yield of each manufacturing batch produced,” said Michael Kamarck, chief technology officer of Vir.
Vir has also contracted with Biogen to conduct cGMP clinical manufacturing in the US, and provide technical support to aid rapid process transfer to large-scale biomanufacturing facilities in the US and other region across the globe.
This agreement will ensure that a reliable supply of the potential commercial product is ensured and can meet demand in key markets.
Vir also expects to begin a phase 2 trial of VIR-7832 this year – the drug shares the same promising characteristics as VIR-7831 but could also function as a therapeutic as well as a preventative T-cell vaccine.
The company also expects to complete preclinical studies of an inhaled SARS-CoV-2 targeting siRNA treatment, VIR-2703, by the end of the year.