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Argenx SE

From EverybodyWiki Bios & Wiki


Argenx SE (/ˈɑːrˈdʒɛn.ɛks/) is an international biopharmaceutical company headquartered in the Netherlands, developing and commercialising humanized monoclonal antibody based therapies. It has major offices in Ghent, Belgium; Boston, USA and Tokyo, Japan as well as regional subsidiaries in Canada, France, Germany and Switzerland.[1][2]

The company has many candidates in its drug pipeline that are being investigated in a variety of disease areas. While some of these are being developed in partnership with pharmaceutical and biotech companies, Argenx also has a proprietary pipeline with a focus on cancer and autoimmune diseases.

Argenx SE
Argenx corporate logo
Formerly
arGEN-X B.V.
Public Company
Traded as
ISIN🆔
IndustryBiotechnology
Founded 📆2008; 18 years ago (2008) in Utrecht, Netherlands
Founders 👔
  • Torsten Dreier
  • Hans J. W. de Haard
  • Tim van Hauwermeiren
Headquarters 🏙️,
Breda
,
Netherlands
Area served 🗺️
Worldwide
Key people
  • Tim van Hauwermeiren, CEO
  • Karl Gubitz, CFO[3]
  • Keith Woods, COO
  • Hans J. W. de Haard, CSO
Products 📟 Efgartigimod
BrandsVyvgart
ServicesImmunotherapy
Revenue🤑 
  • Increase US$497.3 million (2021)
  • US$41.2 million (2020)
[4][2]
  • Increase US$539.4 million (2021)
  • US$64.9 million (2020)
[4][2]
  • Increase US$(408.3 million) (2021)
  • US$(608.5 million) (2020)
[4][2]
Total assets
  • Increase US$2,850.3 million (2021)
  • US$2,279.4 million (2020)
[4][2]
Total equity
  • Increase US$2,534.2 million (2021)
  • US$1,674.0 million (2020)
[4][2]
Members
Number of employees
854 [678 full-time][5] (end 2021)
🌐 Websiteargenx.com
📇 Address
📞 telephone

History

Foundation

The company was incorporated under the name arGEN-X B.V. in Rotterdam on 25 April, 2008 by Hans J. W. de Haard, Torsten Dreier, and Tim van Hauwermeiren[1][4] on the groundbreaking antibody engineering discovery of utilising the diversity of the llama immune system to build differentiated human antibodies.[6][7] Seed financing of 1 million Euros was provided by Erasmus MC and Thuja Capital.[8][9]

The company name is inspired by the Greek mythological tale of the Argonauts and the philosophy that collaboration is key to success.[10][11] It is normally depicted in all lower case lettering both in internal and public-facing branding. The company employees are often referred to as Argonauts.[5]

Flotation

Argenx has been listed since July 2014 on Euronext Brussels and May 2017 on NASDAQ in New York, both under the ticker symbol “ARGX”.[12][13] On 5 June, 2018 Argenx was selected for inclusion in the BEL 20 index.[14][15]

Partnerships

In 2011, Argenx and Eli Lilly & Company entered into a strategic partnership for the research and development of specific antibody targets[7]. A therapeutic antibody alliance with Shire followed in 2012, which was further expanded in 2013 and 2014. Additional partnerships included Boehringer Ingelheim (2013), Bayer (2014), Staten Biotechnology (January 2015), Leo Pharma (May 2015), AbbVie (April 2016) and Janssen-Cilag (December 2018).[16][17]

Key milestones

In 2013, the company’s lead proprietary antibody ARGX-113 entered clinical development.[18]

In December 2020, based on positive clinical trial results, the company submitted a Biologics License Application (BLA) to the FDA for the first of its platform drugs, Efgartigimod (ARGX-113) for the treatment of generalised myasthenia gravis.[19] U.S. marketing approval was granted by the FDA a year later on 17 December, 2021.[20] Filing in Japan with the PMDA took place in January 2021 with approval granted on 20 January, 2022.[21] European filing with the EMA took place in August 2021 with the CHMP adopting a positive opinion and recommending the granting of a marketing authorisation on 23 June 2022.[22]

Technology

Argenx sources antibodies from outbred llamas (whose ‘v’ regions very closely resemble those of human antibodies but are much more potent) by using its proprietary SIMPLE Antibody™ (Superior Immunodiversity with Minimal Protein Lead Engineering) platform.[16][7]

After fine-tuning the properties of the Fc regions of the antibodies using other technologies in its portfolio (NHance ® to extend the half-life/pharmacodynamic effect and enhance tissue penetration; ABDEG™ to clear disease target and autoantibodies; POTELLIGENT ® to boost the ability to kill targeted cells) the antibodies are introduced into the body of the patient. These new antibodies then strengthen and help the natural defences of the human body in order to exterminate, disable or weaken the proposed illnesses.[8][22]

Pipeline

Approved antibodies

Efgartigimod (formerly ARGX-113, brand name Vyvgart: target FcRN) is a first-in-class humanised monoclonal antibody treatment for generalised myasthenia gravis (gMG), a rare condition (incidence: 200 people per million) that leads to the failure or insufficient functioning of the muscles.

In December 2021, efgartigimod was approved by the U.S. Food and Drug Administration to treat adults with gMG who are positive for anti-acetylcholine receptor (AChR) antibodies — the most common type of MG-causing antibody.[20] The therapy also has been approved in Japan to treat adults with gMG, regardless of antibody status, who failed to respond to steroids or nonsteroidal immunosuppressive therapies.[4][21]

In addition to gMG, efgartigimod is being evaluated in several other autoimmune diseases known to be mediated by disease-causing IgG antibodies, including other neuromuscular disorders (Chronic Inflammatory Demyelinating Polyneuropathy, Idiopathic Inflammatory Myopathy), skin blistering diseases (Pemphigus Vulgaris, Pemphigus Foliaceus and Bullous Pemphigoid) and Immune Thrombocytopenia Purpura (ITP). ITP is a relatively rare blood disorder (incidence: 30 people per million) in which the blood does not clot well.[4][13]

Efgartigimod has been awarded orphan drug status in both the U.S. and Europe.[20][22][23] The designation is given to therapies for rare diseases, which are classified in the U.S. as a disorder affecting fewer than 200,000 people, and in the EU as diagnosed in not more than 5 in 10,000 people.[4][24]

Under development

Monoclonal antibody (mAB) Other nomenclature Collaboration / out-licensing Target Indication / disease Clinical phase
ARGX-109[25][7] Gerilimzumab / GB224 Bird Rock Bio / Genor BioPharma IL-6 Rheumatoid Arthritis Phase I concluded
ARGX-110[26][13] Custuzumab Janssen-Cilag CD70 Acute Myeloid Leukemia (AML) and higher-risk Myelodysplastic Syndromes (MDS) Phase I / II
ARGX-111[16] - c-Met Solid tumors and blood cancers Phase I concluded
ARGX-112[4] LP-0145 LEO Pharma IL-22R Atopic dermatitis Phase I
ARGX-114[4] AGMB-101 AgomAb Therapeutics MET Fibrotic, inflammatory, autoimmune and degenerative diseases Pre-clinical
ARGX-115[8] ABBV-151 AbbVie GARP Cancer immunotherapy Phase I
ARGX-116[4] STT-5058 Staten Biotechnology / Novo Nordisk ApoC3 Dyslipidemia Pre-clinical
ARGX-117[2] Broteio Pharma / Prof. Erik Hack, Ph.D C2 Multifocal Motor Neuropathy (MMN) and Kidney indications Phase II
ARGX-118[2] VIB Center for Inflammation / Prof. Bart Lambrecht, M.D. Galectin-10 Airway inflammation Pre-clinical
ARGX-119[5] - MuSK Neuromuscular indications Pre-clinical
ARGX-120[5] - Undisclosed Pre-clinical

Further reading

  • De Haard HJ, Bezemer S, Ledeboer AM, Müller WH, Boender PJ, Moineau S, Coppelmans MC, Verkleij AJ, Frenken LG, Verrips CT. Llama antibodies against a lactococcal protein located at the tip of the phage tail prevent phage infection. J Bacteriol. 2005 Jul;187(13):4531-4541. doi: 10.1128/JB.187.13.4531-4541.2005. PMID: 15968064; PMCID: PMC1151777; S2CID 17257955.
  • Odbileg R, Konnai S, Usui T, Ohashi K, Onuma M. Quantification of llama inflammatory cytokine mRNAs by real-time RT-PCR. J Vet Med Sci. 2005 Feb;67(2):195-198. doi: 10.1292/jvms.67.195. PMID: 15750318; S2CID 28927744.

References

  1. ↑ 1.0 1.1 "ARGX - argenx SE Company Profile - CNNMoney.com". money.cnn.com. Archived from the original on 7 July 2022. Retrieved 2022-07-07.
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 "argenx announces pipeline expansion and "argenx 2021" vision to build integrated immunology company at 2019 R&D Day". AP NEWS. 2021-12-21. Retrieved 2022-08-10.
  3. ↑ "argenx Appoints Karl Gubitz as Chief Financial Officer". AP NEWS. 2021-06-01. Retrieved 2022-08-10.
  4. ↑ 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 4.11 https://www.argenx.com/sites/default/files/report/argenx_report_march_21_2021.pdf
  5. ↑ 5.0 5.1 5.2 5.3 https://www.argenx.com/sites/default/files/media-documents/ARGX_2021_ESG_Report.pdf
  6. ↑ Matsey, Jonathan (2009-09-10). "Llamas Take On New Burden In Laboratory". Wall Street Journal. ISSN 0099-9660. Retrieved 2022-08-10.
  7. ↑ 7.0 7.1 7.2 7.3 Netterwald, James (February 12, 2011). "Finding The Key To Biopharma Start-Up". Life Science Leader. Retrieved August 14, 2022.
  8. ↑ 8.0 8.1 8.2 https://www.argenx.com/sites/default/files/media-documents/20160602_Registration_Document.pdf
  9. ↑ Gormley, Brian (2011-11-30). "OrbiMed, Seventure Lead Series B For Antibody Co. ArGEN-X". Wall Street Journal. ISSN 0099-9660. Retrieved 2022-08-10.
  10. ↑ "About". Argenx. Retrieved 2022-07-07.
  11. ↑ Debruyne, Marion (July 7, 2022). "Entrepreneurship is a Team Sport". www.vlerick.com. Retrieved August 14, 2022.
  12. ↑ "Nasdaq Welcomes argenx (Nasdaq: ARGX) to The Nasdaq Stock Market | Nasdaq, Inc". ir.nasdaq.com. Retrieved 2022-07-07.
  13. ↑ 13.0 13.1 13.2 Koberstein, Wayne (May 1, 2020). "Companies to Watch: argenx". Life Science Leader. Retrieved August 14, 2022.
  14. ↑ "argenx joins the BEL 20 | euronext.com". www.euronext.com. Retrieved 2022-07-08.
  15. ↑ SE, argenx (2018-06-05). "argenx selected for BEL 20 Index". GlobeNewswire News Room. Retrieved 2022-07-08.
  16. ↑ 16.0 16.1 16.2 Plieth, Jacob (June 12, 2014). "Interview – Argen-X rides a new camel to market". www.evaluate.com. Retrieved August 14, 2022.
  17. ↑ Hay, Timothy (2012-02-29). "ArGEN-X Partners With Shire To Develop Antibodies". Wall Street Journal. ISSN 0099-9660. Retrieved 2022-08-10.
  18. ↑ "arGEN-X advances ARGX-113 into preclinical development for autoimmune disorders". Fierce Biotech. 2013-04-25. Retrieved 2022-07-07.
  19. ↑ "FORM 20-F". SEC.GOV. 2020. Retrieved 8 July 2022.
  20. ↑ 20.0 20.1 20.2 Commissioner, Office of the (2021-12-17). "FDA Approves New Treatment for Myasthenia Gravis". FDA. Retrieved 2022-07-07.
  21. ↑ 21.0 21.1 Young-A, Heo (February 18, 2022). "Efgartigimod: First Approval". Drugs. 82 (3): 341–348. doi:10.1007/s40265-022-01678-3. PMC 8855644 Check |pmc= value (help). PMID 35179720 Check |pmid= value (help).
  22. ↑ 22.0 22.1 22.2 "Vyvgart - efgartigimod alfa". European Medicines Agency. June 24, 2022. Archived from the original on 26 June 2022. Retrieved August 14, 2022. Unknown parameter |url-status= ignored (help)
  23. ↑ "Search Orphan Drug Designations and Approvals". www.accessdata.fda.gov. Retrieved 2022-07-07.
  24. ↑ Wexler, Marisa; Carvalho, Joana (January 27, 2022). "Vyvgart (efgartigimod)". Myasthenia Gravis News. Retrieved August 14, 2022.
  25. ↑ Gormley, Brian (2012-10-05). "Antibody Co. RuiYi Nabs ArGEN-X Drug, Advances China-First Strategy". Wall Street Journal. ISSN 0099-9660. Retrieved 2022-08-10.
  26. ↑ "argenx enters exclusive global collaboration and license agreement with Cilag GmbH International, an affiliate of Janssen, for cusatuzumab (ARGX-110)". AP NEWS. 2021-12-28. Retrieved 2022-08-10.

External links


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