argenx to highlight potential first-order FcRn antagonist, Efgartigimod, at upcoming neuromuscular meetings

  • Additional data from the ADAPT Phase 3 trial demonstrates coherent depth of response during the first two cycles of treatment as measured by minimal expression of symptoms
  • Additional ADAPT data as well show consistent improvements in disease score by patient subgroup based on the affected muscle area or Concomitant medication
  • New analyzes show efgartigimod treatment does not impact vaccine immune response
  • Initial data of My Real World® MG Research Study highlightseverity of illness athe burden of treatment of people living with gMG

Breda, Netherlands – October 8, 2021 – argentx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people with severe autoimmune diseases and cancers, today announced the presentation of additional data from the trial of efgartigimod Phase 3 ADAPT for the treatment of generalized myasthenia gravis (gMG). The data will be presented at two upcoming neuromuscular meetings: the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) on October 13-16, 2021 in Aurora, CO and the virtual science session of the Myasthenia Gravis Foundation of America ( MGFA) in October. 30, 2021.

“The additional ADAPT data presented at these important neuromuscular forums strengthens our understanding of the value efgartigimod can offer as a potential treatment for people living with gMG. are all key considerations for an attending physician, ”commented Wim Parys, MD, medical director of argenx. “We also present the first data from our study of real-world evidence, through which we learn more about the severity of gMG and how it can affect a person’s ability to function and impact. negative on his quality of life. We will continue to listen to patients to discover the real burden associated with the management of this chronic debilitating disease. “

AANEM presentations

Title: “Review of the efficacy, safety and tolerability of Efgartigimod in seronegative patients with acetylcholine receptor autoantibodies with generalized myasthenia gravis: subgroup analysis of the phase ADAPT study 3 ” Laureate, President Research Initiative Award
Presenter: Chafic Karam, MD, University of Pennsylvania
Session: Abstract posters Session I and II
Date and Time: Thursday, October 14 from 1:00 p.m. to 1:30 p.m. MDT; 3:30 p.m. – 4:00 p.m. MDT
Site: Poster room

Title: “Minimal expression of symptoms in patients with generalized myasthenia gravis following treatment with Efgartigimod ” Finalist, Best Abstract
Presenter: Tuan Vu, MD, University of South Florida
Session: Abstract posters Session I and II
Date and Time: Thursday, October 14 from 1:00 p.m. to 1:30 p.m. MDT; 3:30 p.m. – 4:00 p.m. MDT
Site: Poster room

Title: “Actual impact reported by patients with myasthenia gravis: initial data from MyRealWorld® MG study ”
Author: Glenn Phillips, Ph.D., Senior Director, Health Economics at argenx
Session: Summary Poster Session III and IV
Date and Time: Friday, October 15 from 1:00 p.m. to 1:30 p.m. MDT; 3:30 p.m. – 4:00 p.m. MDT
Site: Poster room

Title: “Patient burden of generalized myasthenia gravis”
Author: Suraj Muley, MD, Gregory W. Fulton SLA and Neuromuscular Center

Session: Summary Poster Session III and IV
Date and Time: Friday, October 15 from 1:00 p.m. to 1:30 p.m. MDT; 3:30 p.m. – 4:00 p.m. MDT
Site: Poster room

Title: “General guidelines for the management and practice of myasthenia gravis: a cross-sectional survey of community neurologists in the United States. “
Author: Gil Wolfe, MD, University of Buffalo
Session: Summary Poster Session III and IV
Date and time: Friday, October 15 from 1:00 p.m. to 1:30 p.m. MDT; 3:30 p.m. – 4:00 p.m. MDT
Site: Poster room

Title: “Diagnostic adjudication of chronic inflammatory demyelinating polyneuropathy (CIDP) in the ADHERE trial: review of the first 100 cases »
Author: Peter Donofrio, MD, Vanderbilt University
Session: Summary Poster Session III and IV
Date and Time: Friday, October 15 from 1:00 p.m. to 1:30 p.m. MDT; 3:30 p.m. – 4:00 p.m. MDT
Site: Poster room

In addition to the poster sessions listed above, argenx will be hosting a sponsored industry forum at AANEM:

Title: “Burden, Co-morbidities and Treatment of Generalized Myasthenia Gravis: Where Do We Stand?” “
Presenters: Nicholas J. Silvestri, MD, FAAN, University of Buffalo; Neelam Goyal, MD, Stanford Healthcare; John H. Stone, MD, MPH, Massachusetts General Hospital
Dated and the time: Thursday, October 14 from 12:00 p.m. to 1:00 p.m. MDT
Site: Juniper Ballroom

MGFA

Presentations

Title: “Actual impact reported by patients with myasthenia gravis: initial data from the MyRealWorld MG study ”
Author: Vera Bril, MD, University Health Network, University of Toronto
Time: 12:00 p.m. EDT

Title: “Treatment with Efgartigimod of patients with generalized myasthenia gravis shows consistent improvements in all muscle subgroups and independent of background immunosuppressive therapy”
Author: Chafic Karam, MD, University of Pennsylvania
Time: 2:20 p.m. EDT

Title: “Effect of Efgartigimod, a neonatal Fc receptor blocker, on humoral vaccine responses in autoimmune patients”
Author: Jeffrey Guptill, MD, MA, MHS, Duke University
Time: 2:35 p.m. EDT

Posters

Title: “Actual use of IVIG in American adults with generalized myasthenia gravis ”
Author: Glenn Phillips, Ph.D., Senior Director, Health Economics at argenx

About MG
MG is a rare, chronic autoimmune disease in which IgG antibodies disrupt communication between nerves and muscles, causing debilitating and potentially fatal muscle weakness. Over 85% of people with MG progress to generalized MG (gMG) within 18 months, where muscles all over the body may be affected, causing extreme fatigue and difficulty in facial expression, speech, swallowing and mobility. In more severe cases, MG can affect the muscles responsible for breathing. Patients with confirmed AChR antibodies represent 80-90% of the total gMG population. There are approximately 65,000 people in the United States and 20,000 people in Japan living with the disease.

About the CIDP
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of the pathophysiology of the disease is still emerging, there is growing evidence that IgG antibodies play a key role in damage to peripheral nerves. People with CIDP experience fatigue, muscle weakness, and loss of sensation in the arms and legs which may get worse over time or may come and go. These symptoms can significantly affect a person’s ability to function in their daily life. Without treatment, a third of people living with CIDP will need a wheelchair.

About Efgartigimod
Efgartigimod is an experimental antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the recycling process of IgG. Efgartigimod is being investigated in several autoimmune diseases known to be mediated by pathogenic IgG antibodies, including neuromuscular disorders, blood disorders, and skin blisters.

About Argenx
argenx is a global immunology company committed to improving the lives of people with severe autoimmune diseases and cancer. In partnership with leading university researchers as part of its Immunology Innovation Program (IIP), argenx aims to translate advances in immunology into a world-class portfolio of novel antibody-based drugs. argenx is evaluating efgartigimod in several serious autoimmune diseases. argenx is also advancing several early stage investigational drugs within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan and Switzerland. For more information visit www.argenx.com and follow us on LinkedIn.

Media:
Kelsey kirk
kkirk@argenx.com

joke comijn
jcomijn@argenx.com

Investors:
Beth del giacco
bdelgiacco@argenx.com

Michelle greenblatt
mgreenblatt@argenx.com

Forward-looking statements

The content of this announcement includes statements which are, or may be considered, forward-looking statements. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms believe, estimate, anticipate, expect, intend, may, will or should and include statements made by argenx regarding the data. clinics of its product candidates; the expected results of its strategy; the momentum of its product candidate pipeline as well as Argenx’s statements regarding research progress and the number of treatment options; and its plans to partner with human rights organizations. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that such forward-looking statements are not guarantees of future performance. Argenx’s actual results may differ materially from those predicted by forward-looking statements due to various important factors, including Argenx’s expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trials, and development activities of Argenx. products and regulatory approval requirements; argenx’s dependence on collaborations with third parties; estimate the commercial potential of Argenx product candidates; Argenx’s ability to obtain and maintain intellectual property protection for its technologies and drugs; the limited operating history of Argenx; and Argenx’s ability to obtain additional financing for its operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in the documents and reports of the Securities and Exchange Commission (SEC) of Argenx, including in the most recent annual report of Argenx on the form 20-F filed with the SEC and in filings and reports filed by argenx with the SEC. In view of these uncertainties, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx assumes no obligation to publicly update or revise the information contained in this press release, including any forward-looking statements, except as required by law.

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