The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

COVID-19 data repository now available

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Interested in antibody/B-cell and T-cell receptor sequences derived from COVID-19 patients?

The iReceptor Project’s COVID-19 specific data repository has > 180 million sequences of AIRR-seq data (massive repertoires of antibody/B-cell and T-cell receptor sequences) from 5 studies of COVID-19 patients.

The data are available for download in a standard AIRR.tsv format, which makes it easy to import the data into many AIRR.seq analysis programs, and more COVID-19 studies will be available soon.

The iReceptor Gateway allows researchers to compare the COVID-19 data to ~2.5 billion immune receptor sequences from other infectious diseases, cancer studies, autoimmune patients and healthy control individuals. The Gateway can be used, for example, to determine whether antibodies discovered in COVID-19 patients are “public” (appearing in many individuals from many conditions including healthy controls) or “private” (only appearing in patients exhibiting severe COVID-19 reactions). This information and other repertoire comparisons should greatly accelerate the development of anti-COVID therapeutics and vaccines.

Present functionalities include:

  • Search for repertoires satisfying certain metadata (e.g. find all AIRR-seq repertoires from ovarian cancer studies)
  • Search for all repertoires that contain specific CDR3 sequences
  • Search identified repertoires for sequences derived from particular V, D, and J genes and alleles
  • Download sequences from these repertoires in AIRR.tsv format, easily importable to other AIRR-seq analysis tools

The iReceptor Gateway follows the protocols and standards developed by the AIRR-Community to facilitate sharing and analysis of AIRR-seq data. The AIRR Community, part of The Antibody Society, is a grassroots group of immunologists, immunogeneticists and computer scientists dedicated to sharing data through the AIRR Data Commons.  The iReceptor Project implements this Data Commons, and the development of the COVID-specific repository on the iReceptor Gateway follows the call from the AIRR Community for increased sharing of data during the coronavirus crisis.

Researchers interested in sharing data or exploring the AIRR Data Commons through the open iReceptor Gateway should visit www.ireceptor.org and contact support@ireceptor.org for an account.

iReceptor is a member of the iReceptor Plus Consortium.

AIRR-C Software Working Group announces SONAR as the first certified AIRR compliant tool

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SONAR (v3) (Schramm et al. Front Immunol, 2016.) is the first tool certified as compliant with the AIRR-C v1.0 standard for AIRR-Seq software tools.

In an effort to enable rigorous and reproducible immune repertoire research at the largest scale possible, the AIRR-C Software Working Group has established a standard to validate software tools using the AIRR-C Standards and meeting a series of interoperability and quality criteria. Developers interested in certifying their tools should complete the checklist and submit it to the AIRR-C Software Working Group for evaluation and ratification by its members. 

More details can be found at the website AIRR Software WG – Guidance for AIRR Software Tools.

All compliant tools will be issued a badge and listed on the website AIRR Software WG – List of Tools Certified as Compliant.

 

Anti-IL-6R levilimab registered as COVID-19 treatment in Russia

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On June 11, 2020, Biocad announced that the Ministry of Health of the Russian Federation registered levilimab (trade name Ilsira) for patients with severe COVID-19. Developed by Biocad, levilimab is a human monoclonal antibody targeting membrane-bound and soluble forms of the interleukin 6 receptor. It was originally developed for treatment of rheumatoid arthritis. Levilimab received state approval for COVID-19 on June 5, 2020 through a fast-track mechanism according to Decree No. 441 of the Government of the Russian Federation, effective as of April 4, 2020.

The efficacy and safety of levilimab (BCD-089) in patients with severe COVID-19 is being evaluated in a Phase 3 multicenter, randomized, double-blind, placebo-controlled, adaptively designed clinical trial (NCT04397562). Initiated on April 24, 2020, the study includes 204 participants who received a single subcutaneous administration of levilimab at a dose of 324 mg in combination with standard therapy. According to Biocad, the results of a clinical trial of the drug demonstrate that levilimab therapy can significantly reduce mortality among patients with COVID-19.

Antibodies to Watch in a Pandemic

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Broadcast Date: June 30, 2020
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

The extraordinary scope and scale of the COVID-19 pandemic has elicited extraordinary responses world-wide. Organizations located across the globe have mobilized teams to research the SARS-CoV-2 virus and COVID-19, conduct clinical studies of repurposed biologics, and research and develop anti-SARS-CoV-2 biologics. Disruptions at companies and regulatory agencies, however, have raised concerns about the effects of the pandemic on possible approvals of non-COVID-19 antibody therapeutics.

In this webinar, Dr. Janice Reichert (The Antibody Society) will provide an update on non-COVID-19 antibody therapeutics approved so far in 2020, and those that might be approved by the end of the year. She will also discuss the ~ 140 biologics currently in development for COVID-19, which includes over 55 repurposed biologics and over 85 anti-SARS-CoV-2 biologics.

Additionally, Dr. Thomas Schirrmann (YUMAB) will present a case study of an academic and industrial consortium for the fast-track development of a SARS-CoV-2 antibody therapy. He will highlight the challenges of discovering and developing an antibody drug during the present pandemic.

A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert speakers.

Speakers: Dr. Thomas Schirrmann and Dr. Janice Reichert
Date: June 30th, 11am EST, 5pm CEST.

Click Here to Register!

FDA approves Uplizna (inebilizumab-cdon) for NMOSD

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On June 11, 2020, the U.S. Food and Drug Administration approved Uplizna (inebilizumab-cdon) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4)-antibody positive. This rare disease primarily affects the optic nerves and spinal cord. Uplizna is a humanized anti-CD19 monoclonal antibody developed by Viela Bio. By targeting CD19, Uplizna depletes CD19+ B cells and plasmablasts responsible for the production of autoantibodies directed against AQP4, thereby ameliorating symptoms of the disease.

The effectiveness of inebilizumab was demonstrated in the Phase 2/3 N-MOmentum trial (NCT02200770). This study enrolled 230 patients with and without the AQP4-IgG antibody who were randomized 3:1 to receive either 2 doses of 300 mg of inebilizumab as a monotherapy or placebo at Day 1 and Day 15, and then followed for a total of 28 weeks. The primary endpoint (time to first attack) and a majority of the secondary endpoints of the study were met. Of patients in the anti-AQP4 antibody positive group, 89% remained relapse-free during the post-treatment period, compared to 58% of the patients taking placebo. There was no evidence of a benefit in patients who were anti-AQP4 antibody negative. Inebilizumab demonstrated a favorable safety and tolerability profile, with an adverse event rate similar to placebo.

Uplizna is the second antibody therapeutic to be approved in the US for NMOSD. FDA approved Soliris (eculizumab) injection for intravenous use for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody positive in June 2019. Soliris, which targets C5 was first approved by FDA in 2007 for paroxysmal nocturnal hemoglobinuria. A biologics license application for anti-IL6R satralizumab as a possible treatment for NMOSD is currently under review at FDA. More information about antibody therapeutics approved in the US and EU, and those in regulatory review, can be found here.