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the official website of the antibody society

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Three newly certified AIRR-compliant software tools: ImmuneML, CompAIRR and Dandelion

December 9, 2021 by Pam Borghardt

The AIRR Community is excited to announce that three tools have recently been certified as compliant with the AIRR-C v1.0 standard for AIRR-Seq software tools. These are ImmuneML – an ecosystem for machine learning analysis of adaptive immune receptor repertoires, CompAIRR – a tool for ultra-fast comparison of adaptive immune receptor repertoires by exact and approximate sequence matching, and Dandelion – a tool for analyzing single cell BCR/V(D)J 10x Genomics data. 

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. The list includes SONAR, ImmuneDB, Immcantation, ImmuneML, CompAIRR and Dandelion.

Filed Under: AIRR Community Tagged With: Adaptive Immune Receptor Repertoire Community, bioinformatics, Data Standards, diagnostics

FDA grants emergency use authorization to anti-SARS-COV-2 mAb Evusheld

December 8, 2021 by Janice Reichert

On December 8, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

Evusheld, comprising the combination of 2 human anti-SARS-CoV-2 IgG1k antibodies, was derived from B cells from convalescent patients after infection with SARS-CoV-2. Discovered by Vanderbilt University Medical Center, the antibodies bind to distinct sites on the SARS-CoV-2 spike protein. These antibodies were licensed to AstraZeneca in June 2020, and then engineered with mutations that extend half-life (YTE) and reduce Fc receptor and complement C1q binding (L234F, L235E, P331S). The primary data supporting the EUA came from the PROVENT clinical study, which is assessing the safety and efficacy of a single 300 mg dose of AZD7442 compared to placebo for the prevention of COVID-19. At the primary analysis, the study data showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% CI: 46, 90), compared to placebo.

Evusheld is the 4th anti-SARS-CoV-2 antibody product granted an EUA. See our COVID-19 Biologics Tracker for information about other anti-SARS-CoV-2 antibodies.

Filed Under: COVID-19 Tagged With: antibody therapeutics, COVID-19, SARS-CoV-2

WHO retires -mab suffix

December 7, 2021 by Janice Reichert

Without fanfare, the World Heath Organization has announced a new INN monoclonal antibody (mAb) nomenclature scheme that divides the substances that contain an immunoglobulin variable domain into four groups, three for monospecific immunoglobulins and one for bi- and multi-specific immunoglobulins, independent of their type, shape and form. The new INN mAb
nomenclature scheme is used for all substances that contain an immunoglobulin variable domain that binds to a defined target, and that is composed of only immunoglobulin-derived pharmacologically active components. The suffix is preceded by an infix that indicates the target class.

Overview

  • Group 1 -tug for unmodified immunoglobulins
    Monospecific full length and Fc unmodified immunoglobulins of any class. Molecules which might occur as such in the immune system. including: IgG, IgA, IgM, IgD, IgE; only allelic variants; Glycoengineering without mutation; C-terminal lysine deletion without any other mutation in the Fc region
  • Group 2 -bart for antibody artificial
    Monospecific full length immunoglobulins with engineered constant domains (CH1/2/3).
    Monospecific full length immunoglobulins that contain any point mutation introduced by engineering for any reason anywhere (hinge, new glycan attachment site, mixed allelic variants which would not occur in nature, altered complement binding, altered FcRn binding, altered Fc-gamma receptor binding, etc.)
    e.g. IGHG4 with S>P mutation, stabilized IgA
  • Group 3 -mig for multi-immunoglobulin
    Bi- and multi-specific immunoglobulins regardless of the format, type or shape (full length, full length plus, fragments)
  • Group 4 -ment for fragment
    All monospecific domains, fragments of any kind, derived from an immunoglobulin variable domain (all monospecific constructs that do not contain an Fc domain)

Additional details are found here.

Filed Under: International non-proprietary names Tagged With: mab, WHO

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

Did you miss our free Symposium on novel γδ-T cell-directed treatments for cancer?

November 17, 2021 by The Antibody Society


“Emerging cancer therapies leveraging gamma-delta effector T cells”

Hosted by The Antibody Society and co-organized with LAVA Therapeutics.

Empowering the potent and specific anti-tumor activities of γδ-T cells is an emerging and highly exciting approach in the fight against cancer. Two distinct therapeutic approaches are getting particular attention; the first is aimed at tumor-targeted activation using bispecific antibodies or γδ-CART cells, the second involves adoptive transfer or in vivo activation of γδ-T cells. During this symposium you will hear from key opinion leaders about the most recent developments for novel γδ-T cell-directed treatments for cancer, including a panel discussion on key opportunities and perspectives.

Held Monday November 29, 2021, the recorded event is available On Demand!

A panel discussion includes:

· Prof. James Allison, MD Anderson, Houston, TX
· Prof. Padmanee Sharma, MD Anderson, Houston TX
· Prof. Daniel Olive, Imcheck and Aix-Marseille Université, Marseille, FR
· Prof. Jürgen Kuball, University Medical Center, Utrecht, NL
· Dr. Michael Koslowski, GammaDelta Therapeutics, London, UK
· Prof. Hans van der Vliet, LAVA Therapeutics and Amsterdam UMC, Utrecht, NL

Filed Under: Uncategorized

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