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Press release content from Globe Newswire. The AP news staff was not involved in its creation.
PRESS RELEASE: Paid content from Globe Newswire
Press release content from Globe Newswire. The AP news staff was not involved in its creation.

argenx to Highlight Potential First-in-Class FcRn Antagonist Efgartigimod at Upcoming ...

October 8, 2021 GMT

  • Additional data from Phase 3 ADAPT trial demonstrateconsistentdepth of responseacross first two treatment cyclesas measured by minimal symptom expression

  • Additional ADAPT data alsoshow consistent disease score improvements by patient subgroup based on affected muscle domain orconcomitant medication

  • New analyses showefgartigimod treatmentdoes notimpactvaccine immune response

  • Initial datafromMyRealWorld® MG research studyhighlightseverity of diseaseand treatment burdenof people living with gMG

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

“The additional ADAPT data presented during these important neuromuscular forums strengthen our understanding of the value efgartigimod can offer as a potential treatment for people living with gMG. Depth and consistency of disease score improvement, as well as a patient’s ability to mount a vaccine response, are all key considerations for a treating physician,” commented Wim Parys, M.D., Chief Medical Officer of argenx. “We are also presenting the first data from our real-world evidence study, through which we learn more about the severity of gMG and how it can impair a person’s ability to function and negatively impact their quality of life. We will continue to listen to patients in uncovering the real-world burden associated with management of this debilitating, chronic disease.”

AANEM Presentations

Title: “Examination of the Efficacy, Safety, And Tolerability of Efgartigimod in Acetylcholine Receptor Autoantibody Seronegative Patients with Generalized Myasthenia Gravis: Subgroup Analysis of the Phase 3 ADAPT Study” Winner, President Research Initiative Award
Presenter: Chafic Karam, M.D., University of Pennsylvania
Session: Abstract Poster Session I and II
Date and Time: Thursday, October 14 from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm MDT
Location: Poster Hall

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Title: “Minimal Symptom Expression in Patients with Generalized Myasthenia Gravis from Treatment with Efgartigimod” Runner Up, Best Abstract
Presenter: Tuan Vu, M.D., University of South Florida
Session: Abstract Poster Session I and II
Date and Time: Thursday, October 14 from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm MDT
Location: Poster Hall

Title: “Real-world Patient-reported Impact of Myasthenia Gravis: Initial Data From the MyRealWorld ® MG Study”
Author: Glenn Phillips, Ph.D., Senior Director, Health Economics at argenx
Session: Abstract Poster Session III and IV
Date and Time: Friday, October 15 from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm MDT
Location: Poster Hall

Title: “Patient Burden of Generalized Myasthenia Gravis”
Author: Suraj Muley, M.D., Gregory W. Fulton ALS and Neuromuscular Center

Session: Abstract Poster Session III and IV
Date and Time: Friday, October 15 from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm MDT
Location: Poster Hall

Title: “Generalized Myasthenia Gravis Management and Practice Guidelines: Cross-Sectional Survey of Community Neurologists in the United States.”
Author: Gil Wolfe, M.D., University at Buffalo
Session: Abstract Poster Session III and IV
Date and Time: Friday, October 15 from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm MDT
Location: Poster Hall

Title: “Diagnostic Adjudication of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) In the ADHERE Trial: Review of the First 100 Cases”
Author: Peter Donofrio, M.D., Vanderbilt University
Session: Abstract Poster Session III and IV
Date and Time: Friday, October 15 from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm MDT
Location: Poster Hall

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

Title: “Burden, Comorbidities, and Treatment in Generalized Myasthenia Gravis: Where Do We Stand?”
Presenters: Nicholas J. Silvestri, M.D., FAAN, University at Buffalo; Neelam Goyal, M.D., Stanford Health Care; John H. Stone, M.D., MPH, Massachusetts General Hospital
Date and Time: Thursday, October 14 from 12:00 - 1:00pm MDT
Location: Juniper Ballroom

MGFA

Presentations

Title: “Real-world Patient-reported Impact of Myasthenia Gravis: Initial Data From the MyRealWorld MG Study”
Author: Vera Bril, M.D., University Health Network, University of Toronto
Time: 12:00pm EDT

Title: “Efgartigimod Treatment of Patients with Generalized Myasthenia Gravis Demonstrates Consistent Improvements Across All Muscle Subgroups and Regardless of Background Immunosuppressive Therapy”
Author: Chafic Karam, M.D., University of Pennsylvania
Time: 2:20pm EDT

Title: “Effect of Efgartigimod, A Neonatal Fc Receptor Blocker, on Humoral Vaccine Responses in Autoimmune Patients”
Author: Jeffrey Guptill, M.D., MA, MHS, Duke University
Time: 2:35pm EDT

Posters

Title: “Real World IVIG Usage in U.S. Adults With Generalized Myasthenia Gravis”
Author: Glenn Phillips, Ph.D., Senior Director, Health Economics at argenx

About MG
MG is a rare and chronic autoimmune disease where IgG antibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. More than 85% of people with MG progress to generalized MG (gMG) within 18 months, where muscles throughout the body may be affected, resulting in extreme fatigue and difficulties with facial expression, speech, swallowing and mobility. In more life-threatening cases, MG can affect the muscles responsible for breathing. Patients with confirmed AChR antibodies account for 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 CIDP
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person’s ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair.

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

About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines 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 DelGiacco
bdelgiacco@argenx.com

Michelle Greenblatt
mgreenblatt@argenx.com   

Forward Looking Statements

The contents of this announcement include statements that are, or may be deemed to be, forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms believes, estimates, anticipates, expects, intends, may, will, or should and include statements argenx makes concerning the clinical data of its product candidates; the intended results of its strategy; the momentum of its product candidate pipeline as well as argenx’s statements regarding research advancements and number of treatment options; and its plans to partner with advocacy organizations. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for 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 argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

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