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the official website of the antibody society

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Antibodies to Watch in 2021 is now online!

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Click here to download this newly published mAbs article!

In this 12th annual installment of the Antibodies to Watch article series, we discuss key events in antibody therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 in Russia and India, respectively.

Despite the pandemic, 10 antibody therapeutics had been granted first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan.

The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency. Of these 16 mAbs, 11 are possible treatments for non-cancer indications and 5 are potential treatments for cancer.

Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 (leronlimab, tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021. In addition, 44 antibody therapeutics are in late-stage clinical studies for cancer indications. Of these 44, marketing application submissions for 13 may be submitted by the end of 2021.

*Note added in proof on key events announced during December 1-21, 2020: margetuximab-cmkb and ansuvimab-zykl were approved by FDA on December 16 and 21, 2020, respectively; biologics license applications were submitted for ublituximab and amivantamab.

Keep up to date on US and EU approvals all year by visiting our website!

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Successful AIRR Community Meeting V

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The fifth AIRR Community meeting (#AIRRC5) was held virtually Dec 8–10, 2020. The theme of this meeting was “Zooming in to the AIRR Community” connecting the global AIRR research community despite the pandemic for a series of Working Group & Sub-committee presentations, scientific sessions, interactive poster sessions, software tool demonstrations and networking events.

AIRR Community meetings are the premier event for research on adaptive immune-receptor repertoires. They are also the primary location where the AIRR-Community’s Working Groups and Sub-committees come together in one location to discuss how to push standardization in AIRR-sequencing (AIRR-seq) data and analysis forward.  All video recordings can be found here https://www.youtube.com/airrcommunity. All presentations can be found in the AIRR Community Resources section of the website. 

Just as the biology of AIRR is high-dimensional, this meeting’s success was as well!  We gathered some of the numbers that best describe the success of the #AIRRC5 meeting.

  • 1 Keynote speaker: Ignacio Sanz (Emory University School of Medicine, USA)
  • 3 Basic Science Presentations, 3 Biomedical Science Presentations
  • Attendees from 18 countries and 6 continents
  • 161 Registrants 
  • 5 Sponsors 
  • 6 Invited Speakers 
  • 2 Judging Panels 
  • 4 Short Talk Presenters 
  • 28 Poster Presenters 
  • 4 Software Demonstrators 
  • 9 Moderators 
  • 19 Community Presenters 
  • This was the second time a twitter hashtag was used for an AIRR Community Meeting (#AIRRV)
  • We achieved the milestone of more than 100 subscribers for the AIRRC YouTube channel thus enabling a custom YouTube URL: https://www.youtube.com/airrcommunity 
  • In addition to the main meeting, two free pre-meetings were held with over 175 participants
    • Pre-meeting 1: “AIRR-seq in the Pandemic” co-hosted by the AIRR Community and Tsinghua University in China which took place on December 5th/6th
    • Pre-meeting 2 “AIRR-seq Biological Standards and Workflows“ which was hosted by the Biological Resources Working Group on December 7th.

Register now for Pre-Meeting “AIRR-seq in the Pandemic!

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AIRR-seq in the Pandemic:
AIRR Community/Tsinghua University Joint Meeting
A pre-meeting to AIRR-C Meeting V: Zooming in to the AIRR Community!

We are pleased to announce a meeting co-organized by the AIRR Community and Tsinghua University, which will mainly focus on Chinese researchers using AIRR-seq data to study the adaptive immune response, especially in COVID-19 patients. This event has been scheduled as a pre-meeting for the regular AIRR Community Meeting V: “Zooming in to the AIRR Community” which will be held virtually December 8-10th, 2020.  Professor Xiao Liu of Tsinghua University is organizing an in-person meeting of Chinese researchers in Shenzen, China on Sunday December 6, 2020, and researchers from North America and Europe will join this group virtually.

The Timeline:
The in-person meeting will convene all day Sunday, December 6th, 2020 in Shenzhen, China.  North American researchers will virtually introduce the AIRR-seq Community approach and present research on COVID-19 during the evening of Saturday, December 5th, including a welcome by the Chair of the AIRR Community Executive Sub-committee, Dr. Nina Luning Prak; Saturday evening in North America will correspond to the morning of Sunday, December 6th in Shenzhen.  In addition, on the morning of Sunday, December 6th in Europe, two members of the AIRR Community will join from Europe, including Victor Greiff; this will correspond to the afternoon of December 6th in Shenzhen. See the draft agenda below for further details on this complicated enterprise!  And please join us if you can, in this international effort to integrate this important sector of the immunogenetics community more closely with the AIRR Community

For complete details and agenda visit the Pre-Meeting web page.

This virtual meeting is free but registration is required.

Please register for this groundbreaking event!

FDA approves isatuximab-irfc for multiple myeloma

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On March 2, 2020, the U.S. Food and Drug Administration (FDA) approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. FDA granted isatuximab Orphan Drug designation for multiple myeloma. Developed by Sanofi, isatuximab (SAR650984) is a chimeric IgG1 antibody directed against CD38 expressed on malignant plasma cells. The antibody acts through a combination of mechanisms, which may depend on the expression level of the target.

The approval was based on the results of the Phase 3 ICARIA-MM study (NCT02990338) demonstrating a statistically significant improvement in progression-free survival (PFS). This study included 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Patients who received Sarclisa in combination with pomalidomide and low-dose dexamethasone showed improvement in PFS, with a 40% reduction in the risk of disease progression or death compared to patients who received pomalidomide and dexamethasone. These patients also had an overall response rate of 60.4%. Patients who only received pomalidomide and low-dose dexamethasone had an overall response rate of 35.3%.

The European Medicines Agency is currently evaluating a marketing authorization application for isatuximab for the treatment of relapsed/refractory multiple myeloma.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format. Information about other antibody therapeutics that may enter regulatory review in 2020 can be found in ‘Antibodies to watch in 2020’.

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“Antibodies to Watch in 2020” is now online!

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This 2020 installment of the annual ‘Antibodies to Watch’ series documents the antibody therapeutics approved in 2019 and in regulatory review in the United States or European Union, as well as those in late-stage clinical studies, as of November 2019*.  At this time, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab) had been granted a first approval in either the US or EU, and marketing applications for 13 novel antibody therapeutics (eptinezumab, teprotumumab, enfortumab vedotin, isatuximab, [fam-]trastuzumab deruxtecan, inebilizumab, leronlimab, sacituzumab govitecan, satralizumab, narsoplimab, tafasitamab, REGNEB3 and naxituximab) were undergoing review in these regions, which represent the major markets for antibody therapeutics. Also as of November 2019, 79 novel antibodies were undergoing evaluation in late-stage clinical studies. Of the 79 antibodies, 39 were undergoing evaluation in late-stage studies for non-cancer indications, with 2 of these (ublituximab, pamrevlumab) also in late-stage studies for cancer indications. Companies developing 7 (tanezumab, aducanumab, evinacumab, etrolizumab, sutimlimab, anifrolumab, and teplizumab) of the 39 drugs have indicated that they may submit a marketing application in either the US or EU in 2020. Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry’s clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future.

*Note on key updates through December 20, 2019: 1) the US Food and Drug Administration granted accelerated approval to [fam-]trastuzumab deruxtecan (Enhertu) on December 20, 2019; 2) the US Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev) on December 18, 2019, bringing the total number of novel antibody therapeutics granted a first approval in either the US or EU during 2019 to 7; 3) the European Commission approved romosozumab on December 9, 2019; 4) the European Medicines Agency issued a positive opinion for brolucizumab; 5) Sesen Bio initiated a rolling biologics license application (BLA) on December 6, 2019; 6) GlaxoSmithKline submitted a BLA for belantamab mafodotin; 7) Macrogenics submitted a BLA for margetuximab; and 8) the status of the Phase 3 study (NCT04128696) of GSK3359609 in patients with head and neck squamous cell carcinoma was updated to recruiting from not yet recruiting.