- New proteomic analyses show that
rezpegaldesleukin increases the protein levels of immune-regulating
pathways while reducing specific serum proteins known to be
elevated in patients with atopic dermatitis -
SAN
FRANCISCO, Sept. 25, 2024 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced several presentations
for rezpegaldesleukin (REZPEG) at the 2024 European Academy of
Dermatology and Venereology (EADV) Congress. In addition to two
trial-in-progress posters, new proteomic analyses were presented
that showcases a unique serum proteomic profile in patients with
atopic dermatitis (AD).
"As an agonist, REZPEG has a differentiated mechanism of action
which is demonstrated by its unique proteomic profile presented
today at EADV 2024," said Jonathan
Zalevsky, Ph.D., Senior Vice President and Chief Research
& Development Officer at Nektar. "The data show that REZPEG
induces important immunoregulatory pathways, such as IL-10, a key
anti-inflammatory cytokine. In addition, REZPEG reduced specific
cytokines and chemokines which are known to be elevated in patients
with atopic dermatitis and other atopy diseases, including IL-15,
CCL22, CX3CL1, and IL-19. These data provide a greater mechanistic
understanding of how treatment with REZPEG led to dose-dependent
efficacy in the Phase 1b study over
the 12-week treatment period, including its rapid onset of action,
and it also provides insight into pathways that could result in the
sustained efficacy that was observed in that study even after
treatment was removed."
REZPEG is a novel first-in-class regulatory T (Treg) cell
stimulator designed to address the imbalance in the immune system
underlying autoimmune disorders and chronic inflammatory
conditions. REZPEG works by targeting the IL-2 receptor complex and
preferentially stimulating the proliferation of Treg cells without
stimulating cytotoxic CD8+ T and CD4+ T cells, which drive
autoimmune disease, to restore immune balance. REZPEG is currently
being evaluated in two Phase 2b
studies, one in moderate-to-severe AD and one in severe to very
severe alopecia areata (AA). Nektar expects topline data from the
AD study in the first half of 2025 and topline data from the AA
study in the middle of 2025.
"In recent years, significant progress has been made in the
treatment of atopic dermatitis. However, some patients still do not
respond to the available biologics and small molecules. Therefore,
there is a strong need for molecules with different mechanisms of
action, particularly those that are immunoregulatory rather than
immunosuppressive," said Spyridon Gkalpakiotis, M.D., Ph.D., MBA, a
principal investigator on the Phase 2b study of rezpegaldesleukin in atopic
dermatitis and Professor in the Department of Dermatovenerology 3FM
CU and UHKV at the University Hospital Královské Vinohrady,
Prague, Czech Republic. "My
colleagues and I are excited to be a part of a study that can
potentially offer the hope of durable effects and long-term
remission which could change the paradigm of how we treat patients
with atopic dermatitis."
The poster presentations are available for download
at www.nektar.com/science/scientific-posters-and-presentations.
Key details and takeaways from the presentations are as
follows:
Abstract 5560/ePoster P0662: "Serum proteomic
biomarker analysis of the interleukin-2 receptor pathway agonist
rezpegaldesleukin in patients with atopic dermatitis", Yu, et
al.
- Patients with moderate-to-severe AD received 12 or
24 µg/kg REZPEG or placebo once every two weeks for 12 weeks.
The Olink proteomics platform was used to measure the levels of
soluble serum proteins from patients at baseline and throughout the
induction period.
- REZPEG modulated Treg pathways and those involving lymphocyte
immune homeostasis, MHC expression and regulation, ectodomain
shedding of cell surface receptors, as well as cellular migration
and adhesion processes.
- As an IL-2 receptor pathway agonist, REZPEG demonstrated a
unique serum proteomic profile in AD patients, reducing the
expression of serum proteins known to be elevated in patients with
AD and demonstrated an effect on the expression levels of known
targets for current AD therapy.
Abstract 4505/ePoster P0600 (Trial in Progress): "A
Phase 2b, Randomized,
Double-Blinded, Parallel-Group, Placebo-Controlled,
International, Multicenter, Study to Evaluate the Efficacy and
Safety of Rezpegaldesleukin in Adults with Moderate-to-Severe
Atopic Dermatitis", Gkalpakiotis, et al.
- The Phase 2b trial is enrolling
biologic and JAK-inhibitor naïve adults with
moderate-to-severe AD. The primary outcome is reduction in Eczema
Area and Severity Index (EASI) score from baseline at the end of
the treatment induction phase. Secondary and exploratory endpoints
include reduction in Investigator's Global Assessment (IGA) AD
score, affected total body surface area (BSA) improvement, as well
as safety and tolerability.
Abstract 2459/ePoster P2080 (Trial in Progress): "A
Phase 2b Study Evaluating the
Efficacy and Safety of Single Agent Rezpegaldesleukin, an
Interleukin-2 Receptor (IL-2R) Pathway Agonist, in the Treatment of
Severe to Very Severe Alopecia Areata", Reich, et al.
- The Phase 2b trial is
enrolling JAK-inhibitor naïve patients with severe to very
severe alopecia areata. The primary endpoint is percent change from
baseline in Severity Alopecia Tool (SALT) score at the end of the
treatment period. Secondary and exploratory endpoints include
percent change from baseline in SALT score at other assessed
timepoints, safety and tolerability, as well as various patient
reported outcomes.
About REZPEG
Autoimmune and inflammatory diseases cause the immune system to
mistakenly attack and damage healthy cells in a person's body. A
failure of the body's self-tolerance mechanisms enables the
formation of the pathogenic T lymphocytes that conduct this attack.
REZPEG is a potential first-in-class resolution therapeutic that
may address this underlying immune system imbalance in people with
many autoimmune and inflammatory conditions. It targets the
interleukin-2 receptor complex in the body in order to stimulate
proliferation of powerful inhibitory immune cells known as
regulatory T cells. By activating these cells, REZPEG may act to
bring the immune system back into balance.
REZPEG is being developed as a self-administered injection for a
number of autoimmune and inflammatory diseases. It is wholly-owned
by Nektar Therapeutics.
About Nektar Therapeutics
Nektar Therapeutics is a clinical-stage biotechnology
company focused on developing treatments that address the
underlying immunological dysfunction in autoimmune and chronic
inflammatory diseases. Nektar's lead product candidate,
rezpegaldesleukin (NKTR-358), is a novel, first-in-class regulatory
T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and
one in alopecia areata. Our pipeline also includes a preclinical
candidate NKTR-0165, which is a bivalent tumor necrosis factor
receptor type II agonist antibody. Nektar, together with various
partners, is also evaluating NKTR-255, an investigational IL-15
receptor agonist designed to boost the immune system's natural
ability to fight cancer, in several ongoing clinical trials. Nektar
is headquartered in San Francisco, California. For
further information, visit www.nektar.com and follow us
on LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which can
be identified by words such as: "will," "expect," "develop,"
"potential," "advance," "anticipate," and similar references to
future periods. Examples of forward-looking statements include,
among others, statements regarding the therapeutic potential of,
and future development plans for rezpegaldesleukin. Forward-looking
statements are neither historical facts nor assurances of future
performance. Instead, they are based only on our current beliefs,
expectations and assumptions regarding the future of our business,
future plans and strategies, anticipated events and trends, the
economy and other future conditions. Because forward-looking
statements relate to the future, they are subject to inherent
uncertainties, risks and changes in circumstances that are
difficult to predict and many of which are outside of our control.
Our actual results may differ materially from those indicated in
the forward-looking statements. Therefore, you should not rely on
any of these forward-looking statements. Important factors that
could cause our actual results to differ materially from those
indicated in the forward-looking statements include, among others:
(i) our statements regarding the therapeutic potential of
rezpegaldesleukin are based on preclinical and clinical findings
and observations and are subject to change as research and
development continue; (ii) rezpegaldesleukin are investigational
agents and continued research and development for these drug
candidates is subject to substantial risks, including negative
safety and efficacy findings in future clinical studies
(notwithstanding positive findings in earlier preclinical and
clinical studies); (iii) rezpegaldesleukin is in clinical
development and the risk of failure is high and can unexpectedly
occur at any stage prior to regulatory approval; (iv) the timing of
the commencement or end of clinical trials and the availability of
clinical data may be delayed or unsuccessful due to challenges
caused by health epidemics, including the COVID-19 pandemic,
regulatory delays, slower than anticipated patient enrollment,
manufacturing challenges, changing standards of care, evolving
regulatory requirements, clinical trial design, clinical outcomes,
competitive factors, or delay or failure in ultimately obtaining
regulatory approval in one or more important markets; (v) we may
not achieve the expected cost savings we expect from our 2022
corporate restructuring and reorganization plan or our 2023 cost
restructuring plan and we may undertake additional restructuring
and cost-saving activities in the future, (vi) patents may not
issue from our patent applications for our drug candidates, patents
that have issued may not be enforceable, or additional intellectual
property licenses from third parties may be required; and (vii)
certain other important risks and uncertainties set forth in our
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on August 9, 2024. Any
forward-looking statement made by us in this press release is based
only on information currently available to us and speaks only as of
the date on which it is made. We undertake no obligation to update
any forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Contact:
For Investors:
Vivian Wu of Nektar
Therapeutics
628-895-0661
For Media:
David Rosen of Argot Partners
646-461-6387
david.rosen@argotpartners.com
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