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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

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

Join us for ‘Developing a portfolio of first-in-class immune-oncology antibodies’

November 9, 2021 by Janice Reichert

Tuesday November 23, 2021 at 11am ET

What does it take to develop a portfolio of immune-oncology candidates? In this fireside chat, Dr. Tom Burt, Sofinnova Partners SAS, will discuss the strategies needed and the path to building a world-class immuno-oncology biotech, along with Dr. Martin Welschof and experts Drs. Christine Power and Björn Cochlovius. During the session, Dr. Welschof, CEO of BioInvent, a clinical-stage company based in Sweden that is developing immuno-modulatory antibodies for the treatment of cancer, and the panel will detail their experiences of the many facets that contribute to building an innovative clinical stage antibody enterprise, including antibody discovery, clinical development, partnership, manufacturing and finance.

Registration is open, and free of course!

Filed Under: Antibody discovery Tagged With: business development, immune-oncology

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