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the official website of the antibody society

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You are here: Home / Archives for COVID-19

Antibodies to Watch in 2022

November 29, 2021 by Janice Reichert

The On Demand version of this webinar is now available.

In “Antibodies to Watch in 2022”, Drs. Janice Reichert, Alicia Chenoweth and Silvia Crescioli discuss key events in antibody therapeutics development that occurred in 2021 and forecast events that might occur in 2022. The COVID-19 pandemic continued to pose challenges and opportunities to the healthcare system, but companies forged ahead with development plans, resulting in record numbers of antibody therapeutics in late-stage clinical studies and in regulatory review. Globally, regulatory agencies approved a record number of novel antibody-based products, including anti-SARS-CoV-2 antibodies. The speakers provide details of 2021 events and trends in the development of antibody therapeutics projected for 2022.

View On Demand webinar

Filed Under: Antibody therapeutic, Antibody therapeutics pipeline, European Medicines Agency, Food and Drug Administration Tagged With: antibody therapeutics, COVID-19, European Medicines Agency, Food and Drug Administration

Anti-SARS-CoV-2 antibody therapeutics Ronapreve and Regkirona approved in the EU

November 15, 2021 by Janice Reichert

On November 11, 2021, the European Medicines Agency’s human medicines committee recommended authorizing anti-SARS-CoV-2 antibody therapeutics Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19.

  • The Committee recommended authorizing Ronapreve for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. Ronapreve can also be used for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms. The company that applied for authorization of Ronapreve was Roche Registration GmbH.
  • The Committee recommended authorizing Regkirona for treating adults with COVID-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe. The applicant for Regkirona was Celltrion Healthcare Hungary Kft.

On November 12, 2021, the European Commission approved both products.

Filed Under: COVID-19, European Medicines Agency Tagged With: approved antibodies, COVID-19, European Medicines Agency, SARS-CoV-2

Actemra® (tocilizumab) granted emergency use authorization for the treatment of COVID-19

June 25, 2021 by Janice Reichert

On June 24, 2021, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for intravenous Actemra® (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. The EUA was issued to Genentech Inc.

Actemra is a recombinant humanized monoclonal antibody that inhibits inflammation by selectively binding to both soluble and membrane-bound human IL-6 receptors and subsequently inhibiting IL6-mediated signaling through these receptors. The data supporting Actemra’s EUA are derived from four clinical trials, the randomized, controlled, open-label, platform trial “Randomised Evaluation of COVID-19 Therapy” (RECOVERY) and three randomized, double-blind, placebo-controlled trials (EMPACTA, COVACTA and REMDACTA). The most important scientific evidence on the potential benefit of Actemra for its authorized use came from the RECOVERY and EMPACTA trials.

The EUA for Actemra is not equivalent to an approval. According to current labeling, Actemra is FDA approved for rheumatoid arthritis, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.

Filed Under: COVID-19, Food and Drug Administration Tagged With: COVID-19, Emergency Use Authorization, Food and Drug Administration, tocilizumab

EUA issued for anti-SARS-CoV-2 sotrovimab

May 27, 2021 by Janice Reichert

On March 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for sotrovimab (VIR-7831; GSK4182136) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. The EUA was issued to GlaxoSmithKline.

Sotrovimab, a human anti-SARS-CoV2 antibody, is being evaluated in a Phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial in non-hospitalized adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. The EUA is based on an interim analysis of results for 583  patients in the study, 291 and 292  of whom received sotrovimab or placebo, respectively, within five days of onset of COVID-19 symptoms. The primary endpoint was progression of COVID-19 (defined as hospitalization for greater than 24 hours for acute management of any illness or death from any cause) through day 29. Hospitalization or death occurred in 21 (7%) patients who received placebo compared to 3 (1%) patients treated with sotrovimab.

Sotrovimab is administered as a 500 milligram single dose given intravenously over 30 minutes by health care providers.

Prior to the authorization of sotrovimab, FDA issued EUAs for the treatment of mild-to-moderate COVID-19 for two combinations of anti-SARS-CoV-2 monoclonal antibodies. The combination of casirivimab and imdevimab was authorized in November 2020 and the combination of bamlanivimab and etesevimab was authorized in February 2021. In addition, Celltrion’s anti-SARS-CoV-2 antibody regdanvimab (CT-P59; Regkirona) received authorization in South Korea in February 2021.

More than 20 additional anti-SARS-CoV-2 monoclonal antibodies are undergoing evaluation in clinical studies. Of these, 7 monotherapies or combinations are in late-stage clinical studies, including ADG20 (Adagio Therapeutics) and AZD7442 (AstraZeneca). The Antibody Society will continue to track these investigational antibodies and report progress in the future.

Filed Under: COVID-19, Food and Drug Administration Tagged With: COVID-19, Food and Drug Administration, SARS-CoV-2, sotrovimab

AIRR Community and Tsinghua University discuss Chinese research using AIRR-seq data to study adaptive immune response in COVID-19 patients

May 13, 2021 by Pam Borghardt

A meeting focusing on Chinese researchers’ use of AIRR-seq data to study the adaptive immune response – especially in COVID-19 patients – was held recently by the AIRR Community and Tsinghua University.

The purpose of this co-organized meeting was to expose AIRR-seq researchers in China to the philosophy and tools developed by the AIRR Community and help integrate researchers from all over the world through the AIRR Community.

Although collaboration and sharing data internationally is complicated and difficult, this successful meeting was an important step in forming the relationships necessary for overcoming many of these challenges.

Tsinghua University is a major research university in Beijing and a member of the C9 League of Chinese universities. Since its establishment exactly 110 years ago, it has produced many notable leaders in science, engineering, politics, business, academia, and culture. The university is ranked as the 15th best university in the world in the QS World University Rankings and No.1 in Asia by the Asia University Rankings and the U.S. News and World Report.

The meeting followed a hybrid format, combining online lectures by AIRR Community members in the US and Europe in conjunction with an in-person meeting in Shenzhen, China that was organized by Professor Xiao Liu of Tsinghua University’s Shenzhen campus.

The in-person, all-day meeting was held on December 6, 2020 in Shenzhen, which corresponded to Saturday evening December 5 in North America.

The full meeting agenda can be found on the meeting web page and the meeting recording has been posted on the AIRR-C YouTube Channel.

 

Filed Under: AIRR Community, Coronavirus, COVID-19, Uncategorized Tagged With: Adaptive Immune Receptor Repertoire Community, COVID-19, Meetings, SARS-CoV-2

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AIRR Community News

Zooming into the Community III Starts Tomorrow!

May 20, 2025 By Lorissa Corrie

Join us tomorrow for our 10th Anniversary AIRR-C online event! 📢 This virtual two-day meeting marks the 10th anniversary of the founding of the AIRR Community. Join us for a celebration of the AIRR Community and two scientific sessions on “Specificity.” ⚠️ Service announcement: Each registration day is independent, with its own unique Zoom link! […]

New episode of the On AIRR podcast is here!

March 25, 2025 By Lorissa Corrie

In this episode of On AIRR, we welcome Dr. Bjoern Peters, Professor at the La Jolla Institute for Immunology, to discuss the crucial role of high-quality data in AI-driven immunological predictions and diagnostics. Dr. Peters shares his journey from theoretical physics to MHC-binding prediction, leading to his work on the Immune Epitope Database (IEDB) — […]

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