The Antibody Society

the official website of the antibody society

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

WHO’s Open Session on INN to be held on April 12, 2016

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The World Health Organization (WHO) recently introduced new definitions for the assignment of antibody international nonproprietary names (INN). Linear protein sequence is now used to define humanness, which is a substantial change in the method by which therapeutic antibodies were previously classified as chimeric, humanized or human. The new definitions are scientifically flawed, provide results that are inconsistent with names of many existing antibody therapeutics, and do not consider advances in antibody technology and antibody development experience.

The Antibody Society will represent the Antibody Community at large at the WHO’s Open Session at the 62nd consultation on INN for pharmaceutical substances in Geneva on April 12, 2016, and we will request modifications that address the problems with the new system.
To be able to influence the WHO, we need your support. Please support our effort by agreeing to the statement here, and provide your name and contact information.

The Antibody Society’s presentation at the WHO’s Open Session on April 12, 2016 is available to Society members. Please log in to access the presentation, located on the Presentations page in the Members Only section.

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Ixekizumab: Second mAb approved in 2016

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On March 22, ixekizumab (Taltz®) became the second monoclonal antibody product to be granted a first approval in 2016. Ixekizumab targets interleukin-17A, and it was approved by the Food and Drug Administration for treatment of adults with moderate-to-severe plaque psoriasis. A decision by the European Commission on marketing in the European Union is pending; in February 2016, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for ixekizumab for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union who are candidates for systemic therapy.

Obiltoxaximab: First mAb approved in 2016

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Antibody impressionOn March 18, obiltoxaximab (ANTHIM®) became the first monoclonal antibody to be approved in 2016. Obiltoxaximab targets the protective antigen of Bacillus anthracis, and it was approved by the Food and Drug Administration for the treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. Administered intravenously, the product is indicated in both adult and pediatric patients. Efficacy studies in animal models of inhalational anthrax served as the basis for the effectiveness of obiltoxaximab in humans.

A total of 8 additional antibody therapeutics are now undergoing their first regulatory review in the European Union and the Unites States, suggesting that the number of approvals for new antibody products in 2016 may meet or exceed the record set in 2015. The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in these regions. Information about the antibody target, format and year of first approval are included in the table. Please log in to access the table, located in the Members Only section.

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Overview of the antibody therapeutics clinical pipeline now available!

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mabs-coverAntibody therapeutics research and development by the biopharmaceutical industry has undergone remarkable expansion in the past ~ 5 years. Over 100 novel antibodies entered first clinical studies in 2015, and the overall clinical pipeline now includes ~480 antibodies. Importantly for patients, these molecules are progressing through the phases of clinical testing, and being approved for marketing. Over 50 antibody therapeutics for a variety of diseases are in Phase 3 studies. A record number (9 new products) were granted first marketing approvals in the United States or European Union in 2015, and the evidence suggests that a larger number may be approved in 2016. A new presentation now available to Society members shows the number of novel antibodies that entered clinical studies recently, how many are in the three clinical phases, and which antibodies might be approved in 2016. Log in to get the presentation. Not a member? Please join!

Comprehensive meeting report now available to members!

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20150625-example-imageThe 26th Antibody Engineering & Therapeutics meeting, the annual meeting of The Antibody Society, united over 800 participants from all over the world in San Diego from 6-10 December 2015. The latest innovations and advances in antibody research and development were discussed, covering a myriad of antibody-related topics by more than 100 speakers, who were carefully selected by The Antibody Society. As a prelude, attendees could join the pre-conference training course focusing, amongst others, on the engineering and enhancement of antibodies and antibody-like scaffolds, bispecific antibody engineering and adaptation to generate chimeric antigen receptor constructs. The main event covered four days of scientific sessions that included antibody effector functions, reproducibility of research and diagnostic antibodies, new developments in antibody-drug conjugates (ADCs), preclinical and clinical ADC data, new technologies and applications for bispecific antibodies, antibody therapeutics for non-cancer and orphan indications, antibodies to harness the cellular immune system, building comprehensive IgVH-gene repertoires through discovering, confirming and cataloging new germline IgVH genes, and overcoming resistance to clinical immunotherapy. The Antibody Society’s special session focused on “Antibodies to watch” in 2016. Another special session put the spotlight on the limitations of the new definitions for the assignment of antibody international nonproprietary names introduced by the World Health Organization. The convention concluded with workshops on computational antibody design and on the promise and challenges of using next-generation sequencing for antibody discovery and engineering from synthetic and in vivo libraries.

Find the full meeting report in the Members Only section.