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

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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.

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

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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.

COVID-19 AIRR-seq Vaccine Data Available!

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The first AIRR-seq dataset from people who have been vaccinated against COVID-19 is now available in the AIRR Data Commons, accessible through the iReceptor Gateway. As more vaccination studies are made available, researchers will be able to compare these antibody/B-cell and T-cell receptor (BCR/TCR) sequences to the over 1 billion such sequences from studies of COVID-19 patients. Vaccines are designed to elicit the same immune response as that caused by natural infection, and the availability of data from vaccinated individuals will enable direct comparisons between these two types of responses. Such comparisons can determine the effect of different vaccine technologies, measure level of protection against circulating variants, and identify immune pressures leading to future variants. For example, this first vaccination study (Goel et al.) that is now curated in the AIRR Data Commons presents data from five recovered donors at three time points: before vaccination and after the first and second vaccinations, and the comparison suggests that COVID-19 recovered individuals may only require a single vaccine dose to achieve peak immune response. Similar comparisons as new vaccination studies become available will help inform public health decisions such as vaccine dosing and booster schedules.

The AIRR Community encourages and supports researchers in sharing their COVID-19 AIRR-seq data from natural infection and vaccination through the AIRR Data Commons. Now more than ever, access to curated, ready-to-analyze antibody and BCR/TCR sequence data will contribute to rapid health insights and public health strategies worldwide as we work to move through and beyond the COVID-19 global pandemic.

For an overview of the AIRR Data Commons, including demos on how to find and share data, see our recent webinar, The AIRR Data Commons: 4 billion reasons to store, analyze and share antibody/B-cell and T-cell receptor repertoire data.

EUA issued for anti-SARS-CoV-2 sotrovimab

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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.

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

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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.