- Expands pipeline with ARGX-117 and ARGX-118; two new pipeline
candidates from its Innovative Access Program addressing
first-in-class targets
- Highlights formation of two global therapeutic franchises in
neuromuscular and hematology with targeted first commercial launch
in 2021
- Appoints Wim Parys, M.D. as Chief Medical Officer, formerly of
Janssen
May 22, 2019
Breda, the Netherlands / Ghent,
Belgium – argenx (Euronext & Nasdaq: ARGX), a
clinical-stage biotechnology company developing a deep pipeline of
differentiated antibody-based therapies for the treatment of severe
autoimmune diseases and cancer, will be hosting its second R&D
Day today, Wednesday, May 22, 2019, in New York starting at 8:30am
ET. During the event, argenx will present data on two new pipeline
candidates that emerged from its Innovative Access Program (IAP)
and will provide updates on the development plan of cusatuzumab
(ARGX-110) in collaboration with Cilag GmbH International, an
affiliate of the Janssen Pharmaceutical Companies of Johnson &
Johnson. Today, argenx will also bring forward its “argenx 2021”
vision, providing clarity on its strategy to become a fully
integrated immunology company.
“At argenx we are making comprehensive
investments across the organization and planning for nothing less
than building the next great integrated immunology company, which
we will carry out through our “argenx 2021” vision. We are putting
all the elements in place for a sophisticated U.S. launch of
efgartigimod for generalized myasthenia gravis patients, if
approved. We are also working closely with Janssen to advance
cusatuzumab into a broad development plan, starting with a first
Phase 2 registration-directed trial in acute myeloid leukemia (AML)
that is expected to start in the second half of 2019,” commented
Tim Van Hauwermeiren, Chief Executive Officer of
argenx.
“Today we will unveil two new and exciting
candidates from our Innovative Access Program that will further
enrich our immunology pipeline and provide us with ambitious
therapeutic opportunities. As we strive to become a commercial
organization, it is this R&D engine that is a key success
differentiator of argenx, having allowed us to repeatedly identify
first-in-class targets from our academic collaborators and
translate these important targets into significant and sustainable
value for our company and for our stakeholders.”
argenx 2021 Vision
argenx today is announcing its plan to become a
fully integrated, novel immunology company through its “argenx
2021” vision, which will include the building of two commercial
franchises in neuromuscular and hematology. Within the two
franchises are currently three expected pipeline candidates,
including:
- Efgartigimod (ARGX-113) with the potential to address
generalized myasthenia gravis (gMG) and chronic inflammatory
demyelinating polyneuropathy within neuromuscular, and immune
thrombocytopenia within hematology;
- Cusatuzumab with the potential to address acute myeloid
leukemia (AML), high-risk myelodysplastic syndromes (MDS) and other
hematological malignancies within the hematology franchise;
- Newly announced ARGX-117 with the potential to address multiple
indications within both franchises.
By the end of 2021, argenx expects to launch
efgartigimod in the U.S. in its first indication gMG, if approved.
Through the building of commercial franchises, argenx plans to
leverage capabilities and an organizational footprint for
subsequent potential launches across its broad immunology
pipeline.
Pipeline Expansion
argenx today announced the addition of two new
therapeutic candidates, ARGX-117 and ARGX-118, to its proprietary
antibody pipeline. Both emerged from argenx’s IAP, in which it
collaborates closely with academic experts, bringing the argenx
cutting-edge antibody discovery technologies to the heart of novel
target research.
ARGX-117 Targeting C2
ARGX-117 is a next-generation
complement-targeting antibody against C2, an important component of
both the classical and lectin pathways in the complement
cascade. ARGX-117 has the following differentiated
features:
- Unique design to precisely intervene at C2 in the complement
cascade with the intention to balance optimal tolerability and
activity
- Expected attractive pharmacokinetic and pharmacodynamic
properties derived from proprietary antibody engineering that could
potentially translate to convenient dosing schedule
- Pipeline-in-a-product opportunity with potential therapeutic
applications in an array of complement-mediated diseases that fit
within established franchises in neuromuscular and hematology, as
well as in kidney indications
ARGX-117 was developed under a collaboration
with the University Medical Center Utrecht/Broteio Pharma and was
exclusively licensed by argenx in 2018. First-in-human clinical
studies are expected to start in the first quarter of 2020.
argenx also announced that it has exercised its
second exclusive license to Halozyme’s ENHANZE® technology for
ARGX-117 target C2. Under the terms of the collaboration, argenx
will access Halozyme’s well-established subcutaneous delivery
technology for ARGX-117 to provide dosing optionality to patients.
In exchange, argenx will pay Halozyme $10M for access to the second
target in addition to potential future payments of up to $160
million, subject to achievement of specified milestones. Halozyme
will also receive mid-single digit royalties on any future sales of
commercialized products.
ARGX-118 Targeting
Galectin-10
argenx is announcing today that it has exercised
its option to exclusively acquire rights to ARGX-118, a highly
differentiated antibody against Galectin-10, the protein of
Charcot-Leyden crystals, which are implicated as a major
contributor to severe asthma and to the persistence of mucus plugs.
ARGX-118 has the following differentiated features:
- Acts on novel target intended to address mucus plugging, a
large unmet need in airway inflammation
- Unique mechanism of action with observed crystal-dissolving
properties
- Broad potential in severe airway inflammation diseases where
mucus plugging plays a key role, including lung attack or asthma
exacerbation, allergic bronchopulmonary aspergillosis, and chronic
rhinosinusitis with nasal polyps
ARGX-118 was developed under a collaboration
with VIB, a life sciences research institute based in Flanders,
Belgium. The molecule is in the final stages of lead optimization
work.
Appointment of Chief Medical Officer
argenx announced today the appointment of Wim
Parys M.D. as Chief Medical Officer effective July 1, 2019. Dr.
Parys will succeed outgoing Chief Medical Officer Nicolas Leupin,
M.D. who will be departing from the Company. In his role, Dr. Parys
will lead argenx’s clinical development, clinical operations,
regulatory affairs, pharmacovigilance and project management. Dr.
Parys has served as an R&D consultant to argenx since February
2019.
Dr. Parys held several R&D leadership roles
of increasing responsibility at Janssen, J&J and Tibotec,
including Head of Development at Tibotec where he established and
led Tibotec Inc. USA and Head of Development of Janssen’s
Infectious Diseases and Vaccines therapeutic area. Through his
career, he led the development and regulatory submission of seven
now-approved drugs. Most recently, Dr. Parys served as Head of
R&D of the Global Public Health group of Janssen.
“With over 25 years of experience leading
successful clinical programs and sophisticated regulatory
submissions, we are confident Wim is the right leader to advance
our rich pipeline at this pivotal time of growth for argenx. We
believe his strategic vision will strengthen our clinical
development activities and provide us key guidance as we advance to
filing for our first drug approval,” continued Mr. Van
Hauwermeiren.
“We extend our deepest gratitude to Nicolas for
his significant contributions and leadership to argenx over the
last four years. He joined the Company as we were launching the
first efgartigimod patient trials and his innovative thinking led
to the successful late-stage results for this molecule as well as
progress throughout our pipeline. We’re confident his talents will
lead to continued accomplishments.”
Cusatuzumab Development Plan
argenx today announced that its partner Janssen
intends to initiate in the second half of 2019 its first Phase 2
and registration-directed clinical trial of cusatuzumab under the
companies’ strategic collaboration. Cusatuzumab is an anti-CD70
monoclonal antibody for AML, high-risk MDS and other hematological
malignancies. Details of the trial are as follows:
- Expected to enroll up to 150 patients with previously untreated
AML who are not eligible for intensive chemotherapy
- Two-part trial: a dose selection part followed by a safety and
efficacy part at the selected go-forward dose
- In the first part of the study, patients will be randomized to
two dose levels of cusatuzumab (10mg/kg and 20mg/kg) in combination
with azacytidine. The second part of the study is an expansion
cohort at the selected dose to evaluate efficacy and safety of the
combination
R&D Day Details
argenx will host its second R&D day today,
Wednesday, May 22, 2019, in New York with presentations starting at
8:30am ET.
In addition to argenx management, guest speakers
for the event will include:
- Prof. Erik Hack, M.D., Ph.D., Professor of Immunology,
University Medical Center Utrecht
- Prof. Ludo van der Pol, M.D., Ph.D., Associate Professor,
Utrecht University, Neurologist, University Medical Center
Utrecht
- Prof. Bart Lambrecht, M.D., Ph.D., Director, VIB Center
for Inflammation Research at Ghent University
- Dr. Rafael N. Villicana, M.D., Associate Professor, Medical
Director, Kidney Transplantation, Loma Linda University Medical
Center
Webcast information:
A live webcast of today’s presentation will be
available on the Company’s website at www.argenx.com or via this
link. A replay of the webcast will be available for 90 days
following the presentation.
About argenx
argenx is a clinical-stage biotechnology company
developing a deep pipeline of differentiated antibody-based
therapies for the treatment of severe auto-immune diseases and
cancer. The company is focused on developing product candidates
with the potential to be either first-in-class against novel
targets or best-in-class against known, but complex, targets in
order to treat diseases with a significant unmet medical need.
argenx’s ability to execute on this focus is enabled by its suite
of differentiated technologies. The SIMPLE AntibodyTM Platform,
based on the powerful llama immune system, allows argenx to exploit
novel and complex targets, and its three complementary Fc
engineering technologies are designed to expand the therapeutic
index of its product candidates.
www.argenx.com
For further information, please contact:
Joke Comijn, Director Corporate Communications & Investor
Relations (EU)
+32 (0)477 77 29 44
+32 (0)9 310 34 19
info@argenx.com
Beth DelGiacco, Vice President Investor Relations (US)
+1 518 424 4980
bdelgiacco@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 intended results of its strategy; argenx’s
advancement of, and anticipated clinical development, data readouts
and regulatory milestones and plans, including the timing of
planned clinical trials and expected data readouts, related to
cusatuzumab, ARGX-117, including its first-in-human studies, and
ARGX-118; the momentum of its product candidate pipeline; and its
plans to become an integrated immunology company as outlined in the
section titled “argenx 2021 Vision,” including the building of two
commercial franchises in neuromuscular and hematology. 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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