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FDA issues Emergency Use Authorization for bamlanivimab/etesevimab combination

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On February 9, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. Developed by Eli Lilly and Company, bamlanivimab and etesevimab are monoclonal antibodies (mAbs) that target overlapping regions of the SARS-CoV-2 spike protein.

The EUA was based on a randomized, double-blind, placebo-controlled clinical trial in 1,035 non-hospitalized adults with mild to moderate COVID-19 symptoms who were at high risk for progressing to severe COVID-19. Of these patients, 518 received a single infusion of bamlanivimab (2.8 g) and etesevimab (2.8 g) together, and 517 received placebo. The primary endpoint was COVID-19 related hospitalizations or death by any cause during 29 days of follow-up.  Hospitalization or death occurred in 11 (2%) patients treated the mAb combination vs. 36 (7%) patients who received placebo. All 10 deaths (2%) occurred in the placebo group.

The authorized dosage of 700 milligrams bamlanivimab and 1400 milligrams etesevimab administered together is based on analyses of available preclinical, clinical, and virologic data, as well as pharmacokinetic and pharmacodynamic modeling, which, in totality, support that the authorized dosage is expected to have a similar clinical and virologic effect to the dose evaluated in the clinical trial. Use of the mAb combination is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

In November 2020, FDA issued an EUA for a single infusion of 700 mg bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and certain pediatric patients. Since the monotherapy and the combination treatment are expected to benefit patients at high risk of disease progression, both 700 milligrams bamlanivimab alone and the combination of 700 milligrams bamlanivimab and 1,400 milligrams etesevimab administered together will be available under an EUA.

Ultra-fast development of an anti-COVID-19 antibody

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Thursday February 18, 2021 at 8am PT/11am ET/5pm CET

The SARS-CoV-2 pandemic has spread all over the world in the past year and there is still no efficient treatment available for COVID-19, particularly for patients undergoing severe courses, which often lead to fatal consequences. Antiviral drugs such as virus-neutralizing antibody therapeutics are still urgently needed to save millions of lives.
Corat Therapeutics developed a novel SARS-CoV-2 neutralizing, fully human antibody derived from convalescent patients. Ultra-fast development strategies shortened timelines from discovery to GMP manufactured material to less than 8 months. This was possible by parallelizing discovery and development steps, as well as performing crucial steps on risk. First-in-human studies were recently initiated. This webinar gives an overview of the challenges faced during discovery and development of the lead antibody, COR-101.

Speaker: Dr. André Frenzel, YUMAB/CORAT Therapeutics

Click here to register for this free event!

Anti-SARS-CoV-2 casirivimab and imdevimab (REGN-COV2) authorized in the US for COVID-19

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On November 20, 2020, the US Food and Drug Administration authorized the emergency use of casirivimab and imdevimab (REGN-COV2), both of which are recombinant human IgG1 monoclonal antibodies that target the receptor binding domain of the spike protein of SARS-CoV-2. This antibody cocktail has been shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

After reviewing the analysis of Phase 1 and 2 data from the ongoing Phase 1/2/3 NCT04425629 study, the agency concluded that “it is reasonable to believe that casirivimab and imdevimab, administered together, may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential benefits of casirivimab and imdevimab, administered together, outweigh the known and potential risks of such product.”

The EUA letter further states that distribution of REGN-COV2 will be directed by the U.S. government, and its EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated or the EUA is revoked. The authorized dosage is 1,200 mg of casirivimab and 1,200 mg of imdevimab administered together as a single intravenous (IV) infusion over at least 60 minutes via pump or gravity as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.

Regeneron was granted a $450 million contract to manufacture and supply REGN-COV2 by the US government, which has committed to making the doses available to Americans for free. The agreement covers a fixed number of bulk lots, as well as fill/finish and storage activities. Delivery of REGN-COV2 drug product started during the third quarter of 2020, and the company expects to have ~ 80,000 doses available by the end of November, ~200,000 total doses ready by the first week of January 2021, and ~ 300,000 total doses ready by the end of January 2021.

Anti-SARS-CoV-2 bamlanivimab authorized in the US for emergency use

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On November 9, 2020, the US Food and Drug Administration authorized the emergency use of anti-SARS-CoV-2 bamlanivimab (LY-CoV555, LY3819253). The agency stated that “it is reasonable to believe that bamlanivimab may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab when used to treat COVID-19 in such patients outweigh the known and potential risks of such product.”

Bamlanivimab is a human IgG1 antibody directed against the receptor binding domain of the spike protein of the SARS-CoV-2 coronavirus. AbCellera and Eli Lilly and Company partnered on the discovery and development of the antibody, which was derived from B cells of convalescent patients. The EUA was based on review of the topline data from the planned interim analysis of BLAZE-1 (NCT04427501), an ongoing randomized, double-blind, placebo-controlled, Phase 2 dose-finding trial of bamlanivimab monotherapy in outpatients with mild to moderate COVID-19.

The EUA letter indicates that distribution of the authorized bamlanivimab (700 mg/20 mL) will be controlled by the United States Government for use consistent with the terms and conditions of the EUA, and that the EUA is effective only while circumstances exist justifying the authorization of emergency use during the COVID-19 pandemic.

Emergency use authorization requests for anti-SARS-CoV-2 antibodies under FDA review

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On October 7, 2020, Eli Lilly and Company and Regeneron announced that they have submitted requests to the  U.S. Food and Drug Administration (FDA) for emergency use authorizations (EUA) of their anti-SARS-CoV-2 monoclonal antibodies.

Lilly’s EUA request is for bamlanivimab (LY-CoV555) monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. According to the company, up to 100,000 doses of 700 mg LY-CoV555 monotherapy may be available in October, and one million doses available in Q4 2020.

The combination of LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in an outpatient setting is also being evaluated. Lilly anticipates submission of an EUA request for combination therapy in November, and may have data to support a biologics license application submission for combination therapy as early as Q2 2021.

Regeneron’s EUA request is for REGN-COV2, which is a combination of two anti-SARS-CoV-2 monoclonal antibodies (REGN10933 and REGN10987). Regeneron was granted a $450 million contract to manufacture and supply REGN-COV2 by the US government, which has committed to making the doses available to Americans for free. The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of 2020, as well as fill/finish and storage activities. At the time of the EUA request, Regeneron had doses available for ~ 50,000 patients, and expects to have doses available for a total of 300,000 patients within several months.

The Antibody Society is tracking the progress of recombinant biologic COVID-19 interventions in preclinical and clinical studies. Summary data for all anti-SARS-CoV-2 antibodies in clinical studies can be found here.