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 28, 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, shall be deemed to be 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333-274721), and to be part thereof from the date on which this Current Report on Form 6-K is filed, to the extent not superseded
by documents or reports subsequently filed or furnished.
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 28, 2023 |
By: |
/s/ Hemamalini
(Malini) Moorthy |
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Name: Hemamalini (Malini) Moorthy
Title: General Counsel |
Exhibit 99.1
argenx Reports Topline Results from ADVANCE-SC
Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia
- Study
did not meet primary or secondary endpoints
- Favorable safety and tolerability profile consistent with previous clinical trials
- Conference
call scheduled for today, November 28, 2023 at 8:30am ET (2:30pm CET)
Regulated information
– Inside information
November 28, 2023, 7:00am CET
Amsterdam,
the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the
lives of people suffering from severe autoimmune diseases, today announced topline results from the ADVANCE-SC study evaluating VYVGART
Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with primary immune thrombocytopenia (ITP). The study did not meet the primary
endpoint of a sustained platelet count response in chronic ITP patients.
Additional analyses of the dataset are ongoing
and the full results will be presented at an upcoming medical meeting and in a peer-reviewed publication.
“This is not the outcome we had hoped for
patients, but setbacks are part of pioneering a new class of medicines and these data will provide insights into the broader understanding
of FcRn and ITP,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. “We are very grateful to everyone involved
in the ADVANCE-SC study, especially the patients and their families, the investigators, and our internal team who worked tirelessly to
complete this global study. We remain committed to the ITP patient community who urgently needs additional treatment options to manage
this challenging disease, and continue to move forward in our deeper analysis of these results.“
ADVANCE-SC Study Data
ADVANCE-SC is the second of two registrational
trials conducted as part of the ongoing ITP development program for VYVGART and enrolled 207 adult patients with chronic and persistent
ITP. Patients were heavily pre-treated and 75% of patients had received three or more prior ITP therapies.
| ● | Primary
endpoint was not met (p=0.5081); 13.7% (17/124) of treated patients demonstrated a sustained
platelet count response compared to 16.2% (11/68) of placebo patients |
| ● | Secondary
endpoints were not met, including additional endpoints on International Working Group (IWG)
responder status and mean platelet count change from baseline |
| ● | VYVGART
Hytrulo was well-tolerated in ADVANCE-SC; the observed safety and tolerability profile was
consistent with ADVANCE-IV and the confirmed safety profile of VYVGART and VYVGART Hytrulo |
Results
from the first study in the ITP registrational program, ADVANCE-IV, were reported in May 2022. The study met its primary
and key platelet-derived secondary endpoints. ADVANCE-IV formed the basis of the regulatory submission for approval of VYVGART IV for
ITP in Japan, where a decision is expected in the first quarter of 2024.
VYVGART is currently being evaluated in 13 severe
autoimmune diseases, including the registrational ADDRESS study for pemphigus from which topline results are expected around year-end
2023.
Conference Call Details
argenx will host a conference call today at 2:30
pm CET (8:30am ET) to discuss the ADVANCE-SC results. A webcast of the live call and replay may be accessed on the Investors section of
the argenx website.
Dial-in numbers:
Please dial in 15 minutes prior to the live
call.
Belgium | |
32 800 50 201 |
France | |
33 800 943355 |
Netherlands | |
31 20 795 1090 |
United Kingdom | |
44 800 358 0970 |
United States | |
1 888 415 4250 |
Japan | |
81 3 4578 9081 |
Switzerland | |
41 43 210 11 32 |
About the ADVANCE-SC Study
The ADVANCE-SC trial was a randomized, double-blind, placebo-controlled,
multicenter, global trial evaluating the efficacy and safety of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adult patients
with chronic or persistent primary ITP. Enrolled patients had a confirmed ITP diagnosis and a mean entry
platelet count of less than 30x109/L. Patients were on a stable dose of at least one ITP treatment prior to randomization and
had received at least one prior therapy. Concomitant medications permitted included corticosteroids, nonsteroidal immunosuppressive drugs,
fostamatinib or TPO-RAs. The study patients who were on 'watch and wait' at baseline were required to have received at least 2 prior treatments
for ITP.
Patients
were randomized in a 2:1 ratio to receive VYVGART Hytrulo or placebo for a total of 24 weeks as part of the primary trial. The primary
endpoint was measured by the proportion of patients with chronic ITP with a sustained platelet count response defined as achieving platelet
counts of greater than or equal to 50x109/L for at least four of the last six scheduled visits between weeks 19 and
24. Patients who received rescue therapy at week 12 or later, or for whom dose and/or frequency of concurrent ITP therapies increased
at week 12 or later, were considered non-responders. Key secondary endpoints included extent of disease
control over 24-week treatment period, proportion of overall population with sustained platelet count response, an extended primary endpoint
analysis between weeks 17 and 24, and the incidence and severity of WHO-classified bleeding events.
About Immune Thrombocytopenia (ITP)
Immune thrombocytopenia (ITP) is an autoimmune
disorder where immunoglobulin G (IgG) autoantibodies destroy platelets and reduce platelet production, which can lead to an increased
risk of excessive bleeding and bruising. In rare cases, ITP can lead to severe anemia and life threatening gastrointestinal or intracranial
hemorrhages. ITP is also associated with debilitating fatigue and significant impacts on mental health, including anxiety, fear and depression.
Many ITP patients are inadequately controlled on current therapies so a significant unmet need exists for additional treatment
options.
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.
VYVGART
Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It is marketed
in Europe as VYVGART and 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, China and Canada. 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.
For further information, please contact:
Media:
Ben Petok
bpetok@argenx.com
Investors:
Alexandra Roy (US)
aroy@argenx.com
Lynn Elton (EU)
lelton@argenx.com
This press release contains inside information
within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).
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 “aims,” “believes,”
“hope,” “estimates,” “anticipates,” “expects,” “intends,” “may,”
“will,” “should,” or "commitment" and include statements argenx makes concerning argenx’ topline
results from the ADVANCE-SC study of VYVGART Hytrulo in ITP, its commitment to the ITP patient community, its commitment to bringing
VYVGART IV to ITP patients in Japan, where the regulatory review is ongoing based on the success of its first trial, and the expected
timing of such regulatory review decision, the expected timing of the topline results for the registrational ADDRESS study, and its goal
of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. 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 but not limited to argenx’s additional analyses of the dataset from the ADVANCE-SC study of
VYVGART Hytrulo in ITP, expectations regarding the inherent uncertainties associated with development of novel drug therapies, preclinical
and clinical trial and product development activities and regulatory approval requirements, including the approval of VYVGART IV for
ITP patients in Japan and the topline results of the registrational ADDRESS study for pemphigus, the acceptance of our products and product
candidates by our patients as safe, effective and cost-effective, and the impact of governmental laws and regulations on our business.
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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