Omicron variant to become ‘dominant strain’ says professor

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Drugmaker GlaxoSmithKline plc (GSK) in partnership with the US-based Vir Biotechnology, Inc (Vir) announced on Tuesday the results of promising, preclinical studies. In data that is yet to be published in a peer-reviewed journal, GSK said the drug sotrovimab “retains in vitro activity against the full known Omicron spike protein”.The early results were hosted online on the bioRxiv preprint server.

To date, scientists have identified a total of 37 mutations in the Omicron spike protein.

The coronavirus variant, which is officially known as B.1.1.529, was identified last month as a variant of concern by the World Health Organization (WHO).

George Scangos, PhD, Chief Executive Officer of Vir, said: “Sotrovimab is the first monoclonal antibody to report preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the still prevalent and highly contagious Delta variant.

“Given the less than three-fold neutralization shift demonstrated in the pre-clinical pseudo-virus assay, which falls below the FDA authorized fact sheet guidance of less than a five-fold change, we are confident that sotrovimab will continue to provide significant benefit for the early treatment of patients hoping to avoid the most severe consequences of COVID-19.”

Sotrovimab has so far been approved for emergency use in the US and has received a “positive scientific opinion” from the Committee for Human Medicinal Products in the European Union.

The drug has also received conditional marketing authorisation by the UK Medicines and Healthcare Products Regulatory Agency, as well as provisional marketing authorisation in Australia, and conditional marketing authorisation in Saudi Arabia.

Health officials have also approved the drug for use in Japan through “Special Approval for Emergency Pathway”.

According to GSK, preclinical data published on bioRxiv indicate that sotrovimab retains activity against all presently tested variants of concern and interest of the SARS-CoV-2 virus that causes COVID-19.

Omicron: More than 1000 cases in UK already predicts expert

The variants are tracked by the WHO and include the Delta, Delta Plus, Mu and Omicron variants, among others.

Another set of preclinical data published last week also indicated the drug works against the key mutations identified in the Omicron variant.

The drug was designed to latch onto the virus’s spike protein.

At first glance, spike proteins are sharp protrusions on the virus’s body.

They are actually so-called glycoproteins and give the virus a crown-like appearance, hence they name coronavirus, from the Latin word for crown (corona).

Spike proteins allow the virus to latch onto a human cell and gain entry.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “From the outset of our collaboration with Vir we hypothesized that sotrovimab would have a high barrier to resistance and thus could deliver best-in-class potential for the early treatment of patients with COVID-19.

“These preclinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date by the WHO, and we look forward to discussing these results with regulatory authorities around the world.”

Sotrovimab is presently supplied in the US, UK, Japan, Australia, Canada, Switzerland and the United Arab Emirates (UAE).

GSK and Vir have also signed a Joint Procurement Agreement with the European Commission to supply the drug.

Although the drug has been authorised for emergency use in the US by the Drug and Food administration, sotrovimab is not authorised for patients presently hospitalised for COVID-19, patients requiring oxygen therapy and patients “require an increase in baseline oxygen flow rate due to COVID-19”.

GSK said in a statement: “Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19.

“SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID‑19 requiring high flow oxygen or mechanical ventilation.”

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