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Vir Biotechnology parts from GSK in its development of next-gen COVID-19 therapies

Vir Biotechnology (Nasdaq: VIR) has amended its research collaboration with GSK to reflect its ongoing efforts to develop next-generation COVID-19 therapies. The former company said it would continue developing COVID-19 therapies alone or in cooperation with other partners.

Vir and GSK will continue collaborating to ensure ongoing access to the monoclonal antibody sotrovimab, where it remains authorized.

Under the revised terms of the agreement, Vir retains exclusive rights to pursue the development of new therapies resulting from the joint coronavirus vaccine and antibody initiatives, with a tiered royalty payment ranging from low to mid-single digits to GSK.

The companies will continue working on sotrovimab (VIR-7831) and VIR-7832, a monoclonal antibody with a dual mechanism of action aimed at the spike glycoprotein of the SARS-CoV-2 virus.

Today, VIR shares held steady, ticking up 0.11% to $26.18. GSK shares were up about 1% to $36.23.

FDA …

FDA further limits use of GSK’s and Vir’s SARS-CoV-2 antibody sotrovimab

As the omicron BA.2 subvariant has spread, FDA has announced that it will further constrain the use of the investigational monoclonal antibody sotrovimab. The agency announced that it would limit the use of the antibody in some U.S. regions last week.

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) were initially confident that the antibody could hold up to the first omicron subvariant, but the companies have concluded that it is probably ineffective against the BA.2 subvariant.

The FDA has announced that sotrovimab is not currently authorized in areas where the BA.2 subvariant makes up the majority of COVID-19 infections. These areas include the Northeast, much of the Western part of the country and a portion of the Midwest.

The FDA has also withdrawn authorization for sotrovimab in Alaska and major U.S. territories, including Puerto Rico.

Last year, FDA similarly limited the use of Lilly’s bamlanivimab (LY-CoV555)…

FDA amends EUA for SARS-CoV-2 antibody sotrovimab

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) have announced that FDA has concluded that the investigational monoclonal antibody sotrovimab is unlikely to be effective against the omicron BA.2 subvariant, which will soon dominate the U.S.

FDA has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab and its website to exclude the antibody in certain areas.

GSK and Vir were initially optimistic about the antibody’s ability to target the mutations in the spike protein of the original omicron SARS-CoV-2 variant.

Vir shares dropped 13.56% to $21.81. GSK shares were mostly flat, falling 0.046% to $43.28.

The market for SARS-CoV-2 antibodies has been competitive, but emerging variants have limited use of the therapies.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended marketing authorization for AstraZeneca’s (LON:AZN) Evushe…

GSK and Vir file for EUA for intramuscular administration of sotrovimab to treat COVID-19

GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab.

Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of developing severe COVID-19.

Sotrovimab won emergency use authorization (EUA) in the U.S. in May 2021. In addition, it won EU marketing authorization as an early COVID-19 therapy in December 2021.

The companies note that data from the Phase 3 COMET-TAIL trial found that 500-mg intramuscular injection of the monoclonal antibody was non-inferior to intravenous injection.

Interim data from that trial was published in The New England Journal of Medicine last year. Final data were published as a pre-print on medRxiv. GSK and Vir Biotechnology anticipate that the full data will be publi…

Sotrovimab wins EU marketing Authorization as an early COVID-19 therapy

GlaxoSmithKline (LSE/NYSE:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have received marketing authorization from the European Commission for the dual-action monoclonal antibody Xevudy (sotrovimab).

The marketing authorization covers individuals 12 and older who weigh at least 40 kg who do not need supplemental oxygen. It also requires that such individuals have a heightened risk of developing severe COVID-19.

This summer, GSK and VIR had reached a joint procurement agreement with the EC involving 220,000 doses of the drug.

“With today’s marketing authorization we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients,” said Dr. Hal Barron, chief scientific officer and president R&D of GSK, in a statement.

The two companies also have revealed that preclinical data suggest that sotrovimab retains activity against the Omicron variant, which threatens to become the dominant form of …

GSK and Vir upbeat about efficacy of sotrovimab against Omicron

GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant.

In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults and children.

Drawing on preclinical research, the two companies suggest that at least one dose of sotrovimab would protect against Omicron, which WHO has categorized as a variant of concern. The preclinical research involved pseudo-virus testing, including 37 mutations in the Omicron variant spike protein.

Formerly known as VIR-7831, sotrovimab is a monoclonal antibody.

The antibody is the first with “preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the sti…

GSK and Vir Biotechnology seek EUA for COVID-19 monoclonal antibody

GlaxoSmithKline and Vir Biotechnology have filed for emergency use authorization (EUA) for VIR-7831 (GSK4182136), a dual-action SARS-CoV-2 monoclonal antibody.

VIR-7831 is designed to stop SARS-CoV-2 viral entry into cells and accelerate the clearing of infected cells.

VIR-7831 would have a similar indication to other monoclonal antibodies that have won an EUA. It is intended for patients 12 or older who weigh at least 40 kg who have a high risk of hospitalization or death from COVID-19.

One notable example of a monoclonal antibody that has won such an EUA from the FDA is Lilly’s bamlanivimab, which is intended to be used soon after a positive COVID-19 test result is obtained but is contraindicated for patients who are hospitalized COVID-19 infections.

Compared with bamlanivimab, VIR-7831 may offer more resistance to SARS-CoV-2 variants based on preclinical data and a preprint study published in BioRxiv.

The U.S. government recently stopped…

New research suggests neutralizing antibodies could help against COVID-19

This transmission electron microscope image shows SARS-CoV-2 – the virus that causes COVID-19 – isolated from a patient in the U.S. The protrusions visible on the outside are the spike proteins that the virus particles use to fuse with and gain entry to host cells. [Image courtesy of NIAID]

New findings from an international research team suggest that neutralizing antibodies could have a use as a preventative treatment or as a post-exposure therapy against COVID-19.

Their latest findings, which drew on data gathered from Berkeley National Laboratory’s (Berkeley Lab’s) Advanced Light Source (ALS) — suggest that antibodies derived from SARS survivors could potently block entry of SARS-CoV-2 and other closely related coronaviruses into host cells. The scientists, who recently published their work in Nature, noted that the most promising candidate antibody is already on an accelerated development path toward clin…