UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of November 2023
Commission File Number: 001-38097
ARGENX SE
(Translation of registrant’s name into English)
Laarderhoogtweg 25
1101 EB Amsterdam, the Netherlands
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F x
Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
EXPLANATORY NOTE
On November 1, 2023, argenx SE (the “Company”) issued
a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The information contained in this Current Report on Form 6-K,
including Exhibit 99.1, is incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-258251)
and S-8 (File Nos. 333-225375, 333-258253, and 333-274721).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ARGENX SE |
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Date: November 1, 2023 |
By: |
/s/ Hemamalini (Malini) Moorthy |
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Hemamalini (Malini) Moorthy |
Exhibit 99.1
argenx Highlights Data Evaluating VYVGART in
Neuromuscular Autoimmune Disease at AANEM and MGFA Scientific Sessions
Long-term clinical trial and real-world data
illustrate VYVGART® drives consistent, repeatable and clinically meaningful responses, including minimal symptom
expression (MSE) in generalized myasthenia gravis (gMG)
Patients treated with VYVGART experienced consistent
improvements on key quality of life measures based on long-term gMG extension data
Data across multiple indications and dosing
schedules confirm favorable safety profile and no increase in treatment-emergent adverse event rates with longer exposure
Amsterdam, the Netherlands – Nov. 1,
2023 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering
from severe autoimmune diseases, today announced 20 presentations of clinical trial and real-world data from studies of VYVGART®
and VYVGART Hytrulo® (VYVGART) in neuromuscular autoimmune disease. The data presentations will be featured at the
American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting and the Myasthenia Gravis Foundation of America
(MGFA) Scientific Session, taking place in Phoenix, AZ from November 1-4, 2023.
“As leaders in the field of FcRn inhibition, we continue to generate
deep and broad data from our clinical trials, including long-term extension and real-world evidence studies,” said Luc Truyen, M.D.,
Ph.D., Chief Medical Officer at argenx. "With VYVGART for gMG, we continue to show favorable safety and consistent, repeatable clinically
meaningful responses, including the ability of patients to achieve MSE, across three years of treatment. The ADHERE study, the largest
in the history of CIDP, further demonstrates our commitment to the neuromuscular community. These data characterize the broad impact our
first-in-class FcRn blocker can have on the lives of people living with CIDP, and our work to establish its safety and efficacy in the
treatment of CIDP represents an exciting step forward for this community.”
Highlights from Data Presented at AANEM and
MGFA
| · | Consistent, Repeatable Responses: Long-term
clinical data from ADAPT+ and ADAPT-SC+ and real-world data illustrate the ability of VYVGART to provide consistent, repeatable, and clinically
meaningful responses across more than 19 cycles, including improvements in quality-of-life measures, for anti-acetylcholine receptor (AChR)
antibody positive patients with gMG. |
| · | Achievement of Minimal Symptom Expression:
Treatment with VYVGART resulted in 40.5% - 44.6% of patients achieving MSE in ADAPT and ADAPT+. Patients achieving MSE reported quality
of life measures comparable to healthy populations. Similar results were demonstrated in ADAPT-SC+ with 35.5%-40.7% of patients achieving
MSE following treatment with VYVGART Hytrulo. |
| · | ADHERE Results: Positive topline results
from the ADHERE study of VYVGART Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) were first reported in July 2023
and are being presented again during the conference. The full dataset from ADHERE will be presented at a medical meeting in 2024. |
| · | Vaccine Response: Study participants were
able to mount effective humoral immune responses to polyvalent pneumococcal vaccine regardless of whether administered during or after
VYVGART administration. |
| · | Seronegative Population: Long-term treatment
with VYVGART Hytrulo was associated with consistent and repeatable improvements on MG-ADL and MG-QoL15r scales in seronegative (anti-AChR
antibody negative) gMG patients. |
| · | Favorable Safety Profile: VYVGART shows
consistency of safety across multiple indications with TEAE rates that were comparable to placebo, mostly mild to moderate in severity
and did not increase with longer exposure. |
Additional data are being presented from case
studies of gMG patients with LRP4 antibodies, a meta-analysis of quality-of-life outcomes of VYVGART and other gMG treatments, and argenx-sponsored
health economic outcomes research studies demonstrating gMG patients facing social-determinants of health challenges experience health
inequities related to increased utilization of acute care facilities, and delayed diagnosis and access to treatment.
AANEM Poster Presentations (November 1-4, 2023)
# |
Title |
Lead
Author |
Presentation
|
143 |
Efficacy, Safety, And
Tolerability Of Efgartigimod In Patients With Chronic Inflammatory Demyelinating Polyneuropathy: Results From The Adhere Trial
|
Richard
Lewis, MD |
Poster Session I
Nov. 2
6:00 PM - 6:30 PM MST
Poster Session II
Nov. 3
9:30 AM - 10:00 AM MST |
151 |
Long-Term
Safety, Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in Participants With Generalized Myasthenia Gravis: Interim
Analysis of Anti-Acetylcholine Receptor Autoantibody Seronegative Participants in the ADAPT-SC+ Study |
James
F. Howard Jr., MD |
Poster Session I
Nov. 2
6:00 PM - 6:30 PM MST
Poster Session III
Nov. 3
3:00 PM - 3:30 PM MST |
270 |
Dose
Selection and Clinical Development Of Efgartigimod PH20 Subcutaneous In Patients With Generalized Myasthenia Gravis
|
Tuan
Vu, MD |
Poster Session I
Nov. 2
6:00 PM - 6:30 PM MST
Poster Session II
Nov. 3
9:30 AM - 10:00 AM MST |
222 |
Long-Term
Safety, Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in Patients With Generalized
Myasthenia Gravis: Interim Results of the ADAPT-SC+ Study
|
Yuebing
Li, MD, PhD |
Poster
Session I
Nov. 2
6:00 PM - 6:30 PM MST
Poster Session III
Nov. 3
3:00 PM - 3:30 PM MST |
152 |
Long-Term
Safety, Tolerability, and Efficacy of Efgartigimod in Patients With Generalized Myasthenia
Gravis: Concluding Analyses From the ADAPT+ Study
|
James
F. Howard Jr., MD |
Poster
Session I
Nov. 2
6:00 PM - 6:30 PM MST
Poster Session III
Nov. 3
3:00 PM - 3:30 PM MST |
240 |
A
Case of Treatment With Efgartigimod in a Patient With Generalized Myasthenia Gravis and LRP4
Antibodies
|
Eduardo
De Sousa, MD |
Poster
Session I
Nov. 2
6:00 PM - 6:30 PM MST
Poster Session II
Nov. 3
9:30 AM - 10:00 AM MST |
220 |
Overview
Of The Safety Profile From Efgartigimod Clinical Trials In Participants With Diverse Immunoglobulin G-Mediated Autoimmune Diseases
|
Kelly
Gwathmey, MD |
Poster
Session I
Nov. 2
6:00 PM - 6:30 PM MST
Poster Session III
Nov. 3
3:00 PM - 3:30 PM MST |
139 |
Treatment-Related
Inequities in Patients With Generalized Myasthenia Gravis Facing Social Determinants of Health
Challenges: A Survey of Neurologists in the United States
|
A.
Gordon Smith, MD |
Poster
Session I
Nov. 2
6:00 PM - 6:30 PM MST
Poster Session III
Nov. 3
3:00 PM - 3:30 PM MST |
138 |
Diagnosis
Inequities In Patients With Generalized Myasthenia Gravis Facing Social Determinants Of Health
Challenges: A Survey Of Neurologists In The United States
|
A.
Gordon Smith, MD |
Poster
Session I
Nov. 2
6:00 PM - 6:30 PM MST
Poster Session III
Nov. 3
3:00 PM - 3:30 PM MST |
MGFA Oral and Poster Presentations (November 1, 2023)
Title |
Lead
Author |
Presentation
|
Achievement
of Minimal Symptom Expression in Acetylcholine-Receptor Antibody-Positive Participants with Generalized Myasthenia Gravis and Effect
on Disease-Specific Measures in ADAPT/ADAPT+ Studies
|
James
F. Howard, MD |
Oral Presentation
10:07 AM - 10:14 AM MST
|
Subcutaneous
Efgartigimod PH20 Treatment in Participants With Generalized Myasthenia Gravis in ADAPT-SC+: Interim Analyses on Quality of Life,
Efficacy, Tolerability, and Long-Term Safety
|
Tuan
Vu, MD |
Oral Presentation
10:42 AM – 10:49 AM MST |
Racial
Disparities in Acute Care Utilization Outcomes Among Those with Myasthenia Gravis
|
Pushpa
Narayanaswami, MD |
Oral Presentation
9:07 AM - 9:14 AM MST
|
Humoral
Immune Response to Polyvalent Pneumococcal Vaccine in Healthy Participants Receiving Efgartigimod
|
Antoine
Azar, MD |
Poster Session
9:35 AM - 10:05 AM MST |
Network
Meta Analysis of Treatment Options in Generalized Myasthenia Gravis: Impact on Health-Related Quality of Life
|
Gil
Wolfe, MD |
Poster Session
9:35 AM - 10:05 AM MST |
Overview
of the Safety Profile From Efgartigimod Clinical Trials in Participants with Diverse IgG-mediated Autoimmune Diseases
|
Kelly
Gwathmey, MD |
Poster Session
9:35 AM - 10:05 AM MST |
Treatment-Related
Inequities in Patients With Generalized Myasthenia Gravis Facing Social Determinants of Health Challenges: A Survey of Neurologists
in the United States
|
A.
Gordon Smith, MD |
Poster Session
9:35 AM - 10:05 AM MST |
Diagnostic
Inequities in Patients With Generalized Myasthenia Gravis Facing Social Determinants of Health Challenges: A Survey of Neurologists
in the United States
|
A.
Gordon Smith, MD |
Poster Session
9:35 AM - 10:05 AM MST |
Real-World
Burden Associated With Social Determinants of Health Challenges For Individuals Living with Generalized Myasthenia Gravis in the
United States
|
Tom
Hughes |
Poster Session
9:35 AM - 10:05 AM MST |
Real-World
Outcomes of Patients living with Generalized Myasthenia Gravis Initiating Efgartigimod treatment in the United States
|
Cynthia
Qi |
Poster Session
9:35 AM - 10:05 AM MST
|
Association
between patient support program participation and access to efgartigimod treatment for generalized myasthenia gravis
|
Glenn
Phillips |
Poster Session
9:35 AM - 10:05 AM MST
|
More information on the programs are available at AANEM
and MGFA.
See Important Safety Information below and
full Prescribing Information for VYVGART Hytrulo for additional information
Important Safety Information
What is VYVGART®
Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART Hytrulo is a
prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout
the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
IMPORTANT SAFETY INFORMATION
Infection
VYVGART and VYVGART HYTRULO
may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated
patients vs 5% of placebo-treated patients) and respiratory tract infection (33% of efgartigimod alfa-fcab-treated patients vs 29% of
placebo-treated patients). Patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts (12% vs 5%,
respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections
and hematologic abnormalities were mild to moderate in severity. Delay the administration of VYVGART or VYVGART HYTRULO in patients with
an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs,
administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.
Immunization
Immunization with vaccines
during treatment with VYVGART or VYVGART HYTRULO has not been studied; the safety with live or live-attenuated vaccines and the response
to immunization with any vaccine are unknown. Because VYVGART and VYVGART HYTRULO cause a reduction in immunoglobulin G (IgG) levels,
vaccination with live-attenuated or live vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO. Evaluate the need
to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART or
VYVGART HYTRULO.
Hypersensitivity Reactions
Hypersensitivity reactions,
including rash, angioedema, and dyspnea were observed in patients treated with VYVGART or VYVGART HYTRULO. Urticaria was also observed
in patients treated with VYVGART HYTRULO. In clinical trials, hypersensitivity reactions were mild or moderate, occurred within 1 hour
to 3 weeks of administration, and did not lead to treatment discontinuation. Monitor patients during and for one hour after VYVGART administration,
or for at least 30 minutes after VYVGART HYTRULO administration, for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity
reaction occurs during VYVGART or VYVGART HYTRULO administration, discontinue use and institute appropriate supportive measures if needed.
ADVERSE REACTIONS
In Study 1, the most
common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary
tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions
and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus,
bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity
and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously.
Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.
USE IN SPECIFIC POPULATIONS
Pregnancy
As VYVGART and VYVGART
HYTRULO are expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and
benefits should be considered prior to administering live or live attenuated vaccines to infants exposed to VYVGART or VYVGART HYTRULO
in utero.
Lactation
There is no information
regarding the presence of efgartigimod alfa-fcab from administration of VYVGART, or efgartigimod alfa or hyaluronidase from administration
of VYVGART HYTRULO, in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health
benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART or VYVGART HYTRULO, and any potential
adverse effects on the breastfed infant from VYVGART or VYVGART HYTRULO or from the underlying maternal condition.
INDICATION
VYVGART® (efgartigimod
alfa-fcab) for intravenous infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous
injection are each indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor
(AChR) antibody positive.
Please see the full Prescribing
Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO.
About Generalized
Myasthenia Gravis
Generalized myasthenia gravis (gMG) is a rare
and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially
life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months,1 where muscles throughout
the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.1
About Chronic Inflammatory Demyelinating Polyneuropathy
(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 VYVGART
VYVGART is a human IgG1
antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the
first approved FcRn blocker in the United States, EU and China for the treatment of adults with generalized myasthenia gravis (gMG) who
are anti- acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient
response to steroids or non-steroidal immunosuppressive therapies (ISTs).
About VYVGART®
Hytrulo
VYVGART Hytrulo is a
subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®,
and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous
injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating
IgG. It is the first-and-only approved FcRn blocker administered by subcutaneous injection.
VYVGART Hytrulo is the
proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different
proprietary names following approval in other regions.
About argenx
argenx is a global immunology
company committed to improving the lives of people suffering from severe autoimmune diseases. 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 developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S.,
Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing
several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow
us on LinkedIn, Twitter, and Instagram.
References
1 Behin et
al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277.
For further information,
please contact:
Media:
Ben Petok
bpetok@argenx.com
Investors:
Alexandra Roy (US)
ARoy@argenx.com
Forward Looking Statement
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,” “hope,” “estimates,” “anticipates,”
“expects,” “intends,” “may,” “will,” or “should” and include statements argenx
makes concerning the expected consistency, safety, tolerability, efficacy and quality-of-life benefits of VYVGART for patients with gMG
and CIDP; VYVGART’s potential to achieve MSE for patients; and argenx’s planned future presentations of additional study data.
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. 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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