The Antibody Society

the official website of the antibody society

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

Sanne van de Bovenkamp wins The Antibody Society’s first Award for Excellence!

by

Stimulating scientific exchange and education represent important aims of The Antibody Society. The Society therefore supports conferences in the antibody field through financial means and by providing scientific programming advice. The recognition of young and upcoming scientists with an Award for Excellence for best abstracts and presentations is a new Society initiative.

The Society’s first Award for Excellence was presented at the Waddensymposium, Antibodies: Central Players in Therapy and Disease, which was held June 25-26, 2018 in the remote town of Ouddorp in The Netherlands. An independent jury consisting of Prof. Stephen Beers (University of Southampton) and Dr. René Pfeiffle (University of Erlangen) selected Sanne van de Bovenkamp as the overall winner. The jury indicated that they were not only highly impressed by the quality of Sanne’s presentation but also by her demonstrated ability to engage in an insightful scientific discussion.

In her presentation, Sanne described her recent work on the impact of Fab-domain glycosylation in the adaptive antibody response. Her studies demonstrate that Fab-domain glycosylation is subject to clonal selection and impacts on antibody affinity. Sanne performed her graduate work at Sanquin Research with Dr. Theo Rispens.  She is currently a postdoc at the department of Immunohematology and Blood Transfusion at the Leiden University Medical Center in Leiden with Prof. Leendert Trouw. She is pictured here with Society Board of Director’s member Dr. Paul W.H.I. Parren and Prof. Beers.

The Adaptive Immune Receptor Repertoire Community is now part of The Antibody Society!

by

We are pleased and proud to announce the incorporation of the Adaptive Immune Receptor Repertoire (AIRR) Community into the Society.

The AIRR Community is a research-driven group that is organizing and coordinating stakeholders in the use of next-generation sequencing (NGS) technologies to study antibody (Ab)/B-cell and T-cell receptor (TcR) repertoires. Recent advances in sequencing technology have made it possible to sample the immune repertoire in exquisite detail. AIRR sequencing has enormous promise for understanding the dynamics of the immune repertoire in vaccinology, infectious disease, autoimmunity, and cancer biology, but also poses substantial challenges. The AIRR Community was established to meet these challenges. The AIRR Community and its associated meetings and workshops are designed to develop standards and recommendations for: 1) obtaining, analyzing, curating and comparing/sharing NGS AIRR datasets; 2) using and validating tools for analyzing AIRR data; 3) relating AIRR NGS datasets to other “big data” sets, such as microarray, flow cytometric, and MiSeq gene-expression data; and 4) legal and ethical issues involving the use and sharing of AIRR data sets derived from human sources. The proceedings of the workshops, including the recommendations and action plans, will be published to benefit the larger scientific community.

To learn more about the AIRR Community and its work, please explore the items listed under the ‘AIRR Community’ tab above.

First approval for erenumab

by

On May 17, 2018, the U.S. Food and Drug Administration approved erenumab-aooe (Aimovig) for the preventive treatment of migraine in adults. Erenumab is a human monoclonal antibody that targets calcitonin gene-related peptide (CGRP) receptor, thereby blocking the activity of CGRP, which is involved in migraine attacks. The treatment is given by once-monthly subcutaneous injections.

The approval was based on data from three clinical trials that compared erenuman-aooe to placebo. Over 2000 participants were included in the studies. In the first study (STRIVE, NCT02456740), which included 955 participants with a history of episodic migraine, patients administered erenumab-aooe experienced, on average, one to two fewer monthly migraine days than those on placebo over a 6 month period. In the second study (ARISE, NCT02483585), which included 577 patients with a history of episodic migraine, patients administered erenumab-aooe experienced, on average, one fewer migraine day per month than those on placebo over a 3 month period. The third study, which evaluated 667 patients with a history of chronic migraine, patients treated with erenumab-aooe experienced, on average, 2.5 fewer monthly migraine days than those receiving placebo over a three month period.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. As of May 17, a total of 4 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 10 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table, located in the Members Only section.

Like this post but not a member? Please join! Membership is free for students and employees of the Society’s corporate sponsors.

Is R&D of antibody therapeutics for non-cancer diseases in decline?

by

Although cancer is often the focus of attention, antibody-based drugs are developed and approved for many other indications, such as immune-mediated, neurological, ophthalmic and skeletal disorders, as well as cardiovascular/hemostasis, respiratory and infectious diseases. Antibody therapeutics for diseases other than cancer comprise slightly over half (58%) of all  antibody products granted their first approval in either the US or European Union (EU), and they comprise approximately half (48%) of the late-stage commercial pipeline. [1]

The number of first approvals of antibodies for non-cancer diseases is expected to be especially high in 2018, with 3 already approved in either the US or EU (burosomab, ibalizumab, tildrakizumab) and another 7 that may be approved by the end of the year. Burosumab (burosumab-twza; Crysvita), which targets fibroblast growth factor 23, was approved in the EU and US in February and April 2018, respectively, for X-linked hypophosphatemia. The anti-CD4 product ibalizumab-uiyk (Trogarzo) was first approved in the US in March 2018 for treatment of patients with multi-drug resistant HIV infection. Tildrakizumab-asmn (Ilumya), which targets interleukin-23p19, was approved in the US in March for treatment of moderate-to-severe plaque psoriasis. Antibodies for non-cancer indications that may be approved by the end of the year include three for the prevention of migraine (erenumab, fremanezumab, galcanezumab), two for cardiovascular/hemostasis indications (caplacizumab for the treatment of acquired thrombotic thrombocytopenic purpura; lanadelumab for prevention of hereditary angioedema attacks) and one (emapalumab) for treatment of  primary hemophagocytic lymphohistiocytosis, which is a clinical syndrome of hyperinflammation that is lethal if untreated. In addition, romosozumab, which targets sclerostin, is in review in the EU and US as a treatment for osteoporosis, but the US Food and Drug Administration has requested additional clinical data from Phase 3 studies.

Despite the success of antibodies for non-cancer diseases, the percentage of these molecules entering first-in-human studies has recently declined [Figure 1].

Whereas during 2010-2014 antibodies for non-cancer diseases comprised 46-60% of all antibodies entering clinical study each year, they have comprised a declining percentage in all subsequent years (44%, 37% and 22% in 2015, 2016 and 2017, respectively). It must be noted that there was a substantial increase in the total number of antibody therapeutics entering clinical studies during the 2015-17 (ave. 106/year) compared to 2010-2014 (ave. 64/year). Nevertheless, the number of antibodies for non-cancer diseases that entered studies in 2017 was the lowest (so far) in this decade. One reason for this decline may be the current focus of research on antibodies that modulate immune checkpoints or redirect T cells and on immunoconjugates such as antibody-drug conjugates, which are almost exclusively developed as treatments for cancer. While the number of antibodies for non-cancer diseases in Phase 2 studies (~130) is likely sufficient to replenish the number in Phase 3 studies and regulatory review in the short term,  early-stage studies of more will be needed to sustain the flow of these therapeutics onto the market well into the future.

[1] Kaplon H, Reichert JM. Antibodies to watch in 2018. MAbs. 2018 Feb/Mar;10(2):183-203.

Like this post but not a member? Please join! Membership is free for students, post-docs and employees of the Society’s corporate sponsors.

First approval for tildrakizumab-asmn

by

On March 20, 2018, the US Food and Drug Administration (FDA) approved tildrakizumab-asmn (Ilumya) for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab, a humanized IgG1 kappa monoclonal antibody, targets IL-23p19 and blocks the interaction of IL-23 with its receptor, thereby inhibiting release of pro-inflammatory cytokines and chemokines.

FDA approval was supported by results from two Phase 3 trials (reSURFACE 1 and 2) in which patients were randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or placebo (2:2:1; reSURFACE 1), or to tildrakizumab 200 mg, tildrakizumab 100 mg, placebo, or etanercept 50 mg (2:2:1:2; reSURFACE 2). In these trials, the tildrakizumab 200 mg and 100 mg doses were well tolerated and found to be efficacious compared with placebo and etanercept in the treatment of patients with moderate-to-severe chronic plaque psoriasis. The results of both studies were published in The Lancet in July 2017.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. As of March 23, a total of 3 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 8 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table, located in the Members Only section.

Not a member? Please join! Membership is free for students and employees of the Society’s corporate sponsors.