argenx to regain global rights to cusatuzumab
07 Giugno 2021 - 7:00AM
Regulated Information/Inside
Information
June 7,
2021 Breda, the
Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a
global immunology company committed to improving the lives of
people suffering from severe autoimmune diseases and cancer, today
announced it will regain worldwide rights to its anti-CD70 antibody
cusatuzumab from Cilag GmbH International, one of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Interim data
from the Phase 1b ELEVATE trial support continued development in
acute myeloid leukemia (AML) and argenx plans to evaluate options
to enable a path forward.
“We have valued the productive collaboration
with Janssen that has advanced our understanding of cusatuzumab and
its role in AML biology. Together we have generated clinical and
translational data that have optimized the dose of cusatuzumab and
further characterized its effect on cells in the bone marrow,” said
Tim Van Hauwermeiren, Chief Executive Officer of argenx. "We set
our target high with the ELEVATE trial, recognizing that
cusatuzumab would have to add benefit to an already-established
combination regimen. We believe these interim data show that
cusatuzumab could be meaningful to AML patients. We plan to
evaluate all alternatives to advance cusatuzumab on behalf of the
AML community, while maintaining our focus on our priorities - the
launch of efgartigimod and the development of our autoimmune
pipeline."
The ongoing Phase 1b ELEVATE trial is evaluating
cusatuzumab in combination with venetoclax and azacitidine in
newly-diagnosed, elderly patients with AML. The intent-to-treat
(ITT) population included 44 patients. Early efficacy analyses
conducted in all evaluable patients (N=42) after ongoing patients
had completed at least two disease evaluations showed:
- Complete remission (CR) was
observed in 48% (20/42), composite complete remission (CRc)
including CRs with incomplete hematologic recovery was observed in
81% (34/42), and overall response rate (ORR) in 93% (39/42) of the
evaluable population.
- Cusatuzumab was observed to be
well-tolerated and the safety profile was consistent with prior
studies.
- ELEVATE is ongoing; complete
results will be presented in an upcoming peer-reviewed forum.
Additionally, ongoing translational research on
AML patient bone marrow samples from the Phase 2 CULMINATE trial
show a decrease in primitive, monocytic-like blasts and leukemic
stem cells, and an increase in normal myeloid cells, following
treatment with cusatuzumab and azacitidine.
The collaboration and licensing agreement
between argenx and Janssen was initiated in 2018 to develop
cusatuzumab to treat AML and myelodysplastic syndromes (MDS). Under
the terms of the agreement, argenx received $300 million in an
upfront payment, approximately $200 million in an equity investment
from Johnson & Johnson Innovation – JJDC, Inc. (JJDC), and $25
million in milestone payments to date. argenx was notified of
Janssen’s decision to discontinue the collaboration agreement
during a regularly scheduled steering committee meeting on June 4,
2021. Following termination of the collaboration, argenx can elect
that Janssen operationally support the treatment and follow-up of
patients enrolled in ongoing cusatuzumab clinical trials.
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.
For further information, please
contact:
Media:
Kelsey Kirkkkirk@argenx.com
Joke Comijn jcomijn@argenx.com
Investors:
Beth DelGiacco bdelgiacco@argenx.com
Michelle Greenblattmgreenblatt@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,” “could,” “estimates,” “anticipates,” “expects,”
“intends,” “plan,” “may,” “will,” or “should” and include
statements argenx makes concerning the clinical and commercial
potential of cusatuzumab and future clinical studies of cusatuzumab
and statements concerning continued operational support to be
provided by Janssen following termination of the collaboration
agreement. 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 the effects of the COVID-19
pandemic, 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.
Grafico Azioni Argen X (EU:ARGX)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Argen X (EU:ARGX)
Storico
Da Apr 2023 a Apr 2024