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AIRR Community and PrecisionFDA COVID-19 Precision Immunology App-a-thon

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The AIRR Community is helping to lead the PrecisionFDA COVID-19 Precision Immunology App-a-thon.  

This is part of the “precisionFDA Challenges” program, which is designed to engage and improve software that analyzes NGS (next generation sequencing data) through community challenges. There were 68 bioinformaticians pre-registered for the Precision Immunology Challenge, and more are expected to join as the app-a-thon continues.  These “citizen scientists” will form teams to design software that will make AIRR-seq data more available and accessible for immunologists to realize the promise of immunological big data for improved diagnostics and therapeutics in immunotherapy.

The Precision Immunology Challenge uses AIRR-seq repertoire data from COVID-19 patients downloaded from the AIRR Data Commons (VDJServer and iReceptor Public Archive) through the iReceptor Gateway. These data sets have been carefully chosen to include data on patient demography and clinical outcome in order to illuminate the relationship between personalized adaptive immunity molecular data and COVID-19 disease variables.

The AIRR Community Diagnostics Working Group published a blog post as part of this effort, explaining the possible uses of AIRR-seq data in the clinic in the near future.

The app-a-thon runs through February 2021 at which time the apps will be judged for usability, impact and innovation.

 

Register now for Pre-Meeting “AIRR-seq in the Pandemic!

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AIRR-seq in the Pandemic:
AIRR Community/Tsinghua University Joint Meeting
A pre-meeting to AIRR-C Meeting V: Zooming in to the AIRR Community!

We are pleased to announce a meeting co-organized by the AIRR Community and Tsinghua University, which will mainly focus on Chinese researchers using AIRR-seq data to study the adaptive immune response, especially in COVID-19 patients. This event has been scheduled as a pre-meeting for the regular AIRR Community Meeting V: “Zooming in to the AIRR Community” which will be held virtually December 8-10th, 2020.  Professor Xiao Liu of Tsinghua University is organizing an in-person meeting of Chinese researchers in Shenzen, China on Sunday December 6, 2020, and researchers from North America and Europe will join this group virtually.

The Timeline:
The in-person meeting will convene all day Sunday, December 6th, 2020 in Shenzhen, China.  North American researchers will virtually introduce the AIRR-seq Community approach and present research on COVID-19 during the evening of Saturday, December 5th, including a welcome by the Chair of the AIRR Community Executive Sub-committee, Dr. Nina Luning Prak; Saturday evening in North America will correspond to the morning of Sunday, December 6th in Shenzhen.  In addition, on the morning of Sunday, December 6th in Europe, two members of the AIRR Community will join from Europe, including Victor Greiff; this will correspond to the afternoon of December 6th in Shenzhen. See the draft agenda below for further details on this complicated enterprise!  And please join us if you can, in this international effort to integrate this important sector of the immunogenetics community more closely with the AIRR Community

For complete details and agenda visit the Pre-Meeting web page.

This virtual meeting is free but registration is required.

Please register for this groundbreaking 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.