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“Antibodies to watch in 2019”

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The latest “Antibodies to watch” article is now freely accessible at mAbs! 

For the past 10 years, the annual ‘Antibodies to watch’ articles have provided updates on key events in the late-stage development of antibody therapeutics, such as first regulatory review or approval, that occurred in the year before publication or were anticipated to occur during the year of publication. To commemorate the 10th anniversary of the article series and to celebrate the 2018 Nobel Prizes in Chemistry and in Physiology or Medicine, which were given for work that is highly relevant to antibody therapeutics research and development, the scope of the data presented was expanded to include an overview of all commercial clinical development of antibody therapeutics and approval success rates for this class of molecules. The data indicate that: 1) antibody therapeutics are entering clinical study, and being approved, in record numbers; 2) the commercial pipeline is robust, with over 570 antibody therapeutics at various clinical phases, including 62 in late-stage clinical studies; and 3) Phase 1 to approval success rates are favorable, ranging from 17–25%, depending on the therapeutic area (cancer vs. non-cancer).

As of November 2018, a record number of antibodies (erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality), burosumab (Crysvita), lanadelumab (Takhzyro), caplacizumab (Cablivi), mogamulizumab (Poteligeo), moxetumomab pasudodox (Lumoxiti), cemiplimab (Libtayo), ibalizumab (Trogarzo), tildrakizumab (Ilumetri, Ilumya), emapalumab (Gamifant)) that treat a wide variety of diseases were granted a first approval in either the European Union (EU) or United States (US). Also as of November 2018, 4 antibody therapeutics (sacituzumab govitecan, ravulizumab, risankizumab, romosozumab) were being considered for their first marketing approval in the EU or US, and an additional 3 antibody therapeutics developed by Chinese companies (tislelizumab, sintilimab, camrelizumab) were in regulatory review in China. In addition, the data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019. Notably, approximately half (18 of 33) of the late-stage pipeline of antibody therapeutics for cancer are immune checkpoint modulators or antibody-drug conjugates. Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus ‘antibodies to watch’. The Antibody Society looks forward to documenting progress made with these and other ‘antibodies to watch’ in the next installment of this article series.

Update: Data in “Antibodies to watch in 2019” is as of November 2018. As noted in the post below, risankizumab was approved by FDA on December 21, 2018, bringing the total number of antibody therapeutics approved in the EU or US during 2018 to 13.

The Antibody Society at Antibody Engineering & Therapeutics 2018

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The Antibody Society held its 2018 annual meeting at Antibody Engineering & Therapeutics in San Diego on December 9-13. It was a a great opportunity for the board members and volunteers to meet our society members and provide updates on Society initiatives.

Informative keynote addresses were given by Prof. Andreas Plückthun (University of Zurich), Prof. David Baker (University of Washington), Prof. Rachael Clark (Harvard Medical School) and Dr. Badrul Chowdhury (Medimmune).

One of the highlights of the conference was the Antibodies to Watch in 2019 presentation by Dr. Janice Reichert (Executive Director of TAbS and Editor-in-Chief of mAbs).


The ‘Antibodies to watch in 2019’ paper is currently online in the accepted (manuscript) form. Society members will be informed when the final article, which will be open access, is available.

The Antibody Society booth at Antibody Engineering &Therapeutics

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

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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.

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