Monoclonal antibodies: GSK and Vir to seek US approval for their COVID-19 candidate, EMA starts rolling review of Lilly's medicines

By Jane Byrne contact

- Last updated on GMT

© GettyImages/CIPhotos
© GettyImages/CIPhotos

Related tags: Monoclonal antibodies

GSK and its partner, Vir Biotechnology, report that their jointly developed monoclonal antibody, VIR-7831, reduces hospitalization and risk of death in early treatment of adults with COVID-19.

A global phase 3 clinical trial, COMET-ICE, based its initial analysis on data from 583 patients at risk of hospital admission.

The partners said VIR-7831 is a new treatment for people with mild to moderate COVID-19 illness, and the efficacy seen in the trial was such that an independent data monitoring committee recommended stopping the study early; enrolment of patients has ended.

An 85% reduction in hospitalization or death was seen in the trial.

Research collaboration 

In April 2020, Vir and GSK entered into a partnership to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The alliance uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies. The partners say that, in contrast to other monoclonal antibodies, VIR-7831 binds to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. 

Patients will continue to be followed for 24 weeks; additional results, including epidemiology and virology data, will be forthcoming once the trial is completed, said the team.

A separate laboratory study has found that VIR-7831 is effective against current COVID-19 variants, including the UK, South African and Brazilian strains.

GSK and Vir Biotechnology said the plan now is to immediately seek an emergency use authorization (EUA) for VIR-7831 in the US as well as approval in other countries.

Data from the trial will also form the basis for a Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA), they added.

VIR-7831 is designed to be given as a single intravenous (IV) infusion.

Dr Hal Barron, chief scientific officer at GSK, said: “We look forward to the possibility of making VIR-7831 available to patients as soon as possible and to further exploring its potential in other settings.”

In addition to COMET-ICE, the full COMET clinical development program for VIR-7831 includes:

  • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity and pharmacokinetics between VIR-7831 manufactured by different processes.
  • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
  • COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.

EU review Lilly’s COVID-19 focused antibodies

Meanwhile, the European Medicine Agency (EMA) said it has started a ‘rolling review’ of data on the antibodies, bamlanivimab and etesevimab, which are being developed by US pharma group, Eli Lilly, to be used in combination for the treatment of COVID-19.

The review by the EMA’s human medicines committee (CHMP) will also look at bamlanivimab used alone.

The decision to start the rolling review is based on preliminary results from two studies. However, EMA said it has not yet evaluated the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicines.

The agency has started evaluating the first batch of data, which come from animal studies, non-clinical data.

It said it will evaluate all data on these medicines, including evidence from clinical trials as they become available. “The rolling review will continue until enough evidence is available to support formal marketing authorization applications.”

While it said that the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained from this fast-tracking process.

Bamlanivimab and etesevimab are two monoclonal antibodies with activity against COVID-19. They have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When they attach to the spike protein, the virus cannot enter the body’s cells. Because the antibodies attach to different parts of the protein, using them in combination may have a greater effect than using either alone, said the EMA.

Clinical study outcome

Separately, Lilly yesterday announced its combination antibody therapy to fight COVID-19 reduced the risk of hospitalization and death by 87%, in a study of 769 high-risk coronavirus patients.

It is the second large, late-stage trial to suggest that the combination therapy of bamlanivimab and etesevimab is effective at treating mild to moderate COVID-19 cases.

Daniel Skovronsky, chief scientific officer at Lilly, said: “These positive results reinforce our previous findings and support the authorized dose of bamlanivimab 700 mg with ​etesevimab 1400 mg.

He added that the consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the US.

Related topics: Markets & Regulations, Pipelines, COVID-19

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