SAN FRANCISCO, June 1, 2014 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ:NKTR) announced positive preclinical data for
NKTR-214, a new investigational cancer immunotherapy which
selectively activates the IL-2 receptor complex and is being
developed as a potential treatment for multiple cancers. The
results were presented today at the 2014 ASCO Annual Meeting in
Chicago.
"When NKTR-214 is combined with either anti-CTLA-4 or anti-PD-1,
we observe dramatic efficacy in highly aggressive tumor models,"
said Stephen Doberstein, Ph.D.,
Senior Vice President and Chief Scientific Officer of Nektar
Therapeutics. "The tumor growth inhibition we observed with
NKTR-214 and anti-PD-1 dosing in a highly aggressive breast tumor
model was superior to the combination of the two antibodies in this
same model and was also very well-tolerated. This ability to
exploit complementary pathways in the immune system by combining
NKTR-214, a new immune activator, with an effective checkpoint
inhibitor, such as anti-CTLA-4 or anti-PD-1, holds promise for
durable responses in patients."
Preclinical Studies Presented at ASCO
Nektar
scientists conducted a series of studies using preclinical models
of breast tumors (EMT6) and colon tumors (CT26) to assess both
single agent and combination dosing of NKTR-214 with checkpoint
inhibitors, either an anti-PD-1 therapy or an anti-CTLA-4 therapy.
The studies also compared NKTR-214 single agent and combination
dosing regimens with single agent and combination dosing regimens
of anti-PD-1 and anti-CTLA-4 therapies. In both the breast and
colon tumor models, the combination dosing regimens of NKTR-214
therapy with anti-PD-1 therapy or anti-CTLA-4 therapy resulted in
significant tumor growth inhibition. In the aggressive EMT6 breast
tumor model where activity with single-agent anti-PD-1 therapy or
single-agent anti-CTLA-4 therapy was not observed, pre-dosing of
NKTR-214 followed by anti-PD-1 demonstrated better efficacy (tumor
growth inhibition of 74%) as compared to a concomitant dosing
regimen of anti-CTLA-4 and anti-PD-1 therapies (tumor growth
inhibition of 23%). NKTR-214 was also very well-tolerated
when co-dosed with either antibody.
NKTR-214 Preclinical Data Presentation
The ASCO data
presentation can be accessed at:
http://www.nektar.com/pdf/pipeline/NKTR-214/NKTR-214_ASCO_Poster_2014.pdf
About NKTR-214
NKTR-214 is a selective immune
stimulator, which is designed to stimulate the patient's own immune
system to kill tumor cells. The molecule uses Nektar's
targeted polymer conjugate technology to enable selective
activation of immunostimulatory IL-2 receptors, which is a novel
mechanism of action in immunotherapy. Existing IL-2 therapy
activates both immunosuppressive as well as immunostimulatory
receptors, which has limited its utility in clinical settings. The
design of NKTR-214 enhances CD8+ memory effector T cells
(tumor-killing cells) in the tumor without increasing regulatory T
cells (immune suppressor cells). In addition, the polymer conjugate
structure of NKTR-214 increases the exposure of NKTR-214 to the
tumor by 500-fold compared to existing IL-2 therapy, allowing, for
the first time, antibody-like dosing frequency of a cytokine with a
favorable tolerability profile. NKTR-214 is currently
undergoing further IND-enabling studies.
About Nektar
Nektar Therapeutics (NASDAQ: NKTR) is a
biopharmaceutical company developing novel therapeutics based on
its PEGylation and advanced polymer conjugation technology
platforms. Nektar has a robust R&D pipeline of potentially
high-value therapeutics in oncology, pain and other therapeutic
areas. In the area of pain, Nektar has an exclusive worldwide
license agreement with AstraZeneca for naloxegol (NKTR-118), an
investigational drug candidate, which has been filed for regulatory
approvals in the U.S., Europe and
Canada as a once- daily, oral
tablet for the treatment of opioid-induced constipation. This
agreement also includes NKTR-119, an earlier stage development
program that is a co-formulation of naloxegol and an opioid.
NKTR-181, a novel mu-opioid analgesic molecule for chronic pain
conditions, has completed Phase 2 development in osteoarthritis
patients with chronic knee pain. NKTR-171, a new sodium channel
blocker being developed as an oral therapy for the treatment of
peripheral neuropathic pain, is in Phase 1 clinical development. In
oncology, etirinotecan pegol (NKTR-102) is being evaluated in a
Phase 3 clinical study (the BEACON study) for the treatment of
metastatic breast cancer and is also in Phase 2 studies for the
treatment of ovarian, colorectal, lung and brain cancers. In
anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by
Bayer Healthcare as an adjunctive treatment for intubated and
mechanically ventilated patients with Gram-negative pneumonia.
Additional development-stage products that leverage Nektar's
proprietary technology platform include Baxter's BAX 855, a long-acting PEGylated
rFVIII program, which is in Phase 3 clinical development for
patients with hemophilia A.
Nektar's technology has enabled eight approved products in the
U.S. or Europe through
partnerships with leading biopharmaceutical companies, including
UCB's Cimzia® for Crohn's disease and rheumatoid
arthritis, Roche's PEGASYS® for hepatitis C and Amgen's
Neulasta® for neutropenia.
Nektar is headquartered in San
Francisco, California, with additional operations in
Huntsville, Alabama and
Hyderabad, India. Further
information about the company and its drug development programs and
capabilities may be found online at http://www.nektar.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by words such
as: "anticipate," "intend," "plan," "expect," "believe," "should,"
"may," "will" and similar references to future periods. Examples of
forward-looking statements include, among others, statements we
make regarding the therapeutic potential of NKTR-214 and the
potential of our technology and drug candidates in our research and
development pipeline. 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) positive preclinical efficacy
findings, such as those for NKTR-214 reported in this press
release, are subject to inherent scientific and medical
uncertainties typical for this early stage of drug development and
may not be confirmed in subsequent preclinical studies or in
clinical trials, if any; (ii) NKTR-214 is in early stage research
and there are a number of hurdles, including the successful
completion of preclinical toxicology studies, prior to the
potential commencement of clinical studies for NKTR-214; (iii) our
drug candidates and those of our collaboration partners are in
various stages of clinical development and the risk of failure is
high and can unexpectedly occur at any stage prior to regulatory
approval for numerous reasons including safety and efficacy
findings even after positive findings in previous preclinical and
clinical studies; (iv) the timing of the commencement or end of
clinical trials and the commercial launch of our drug candidates
may be delayed or unsuccessful due to 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) scientific discovery of new medical
breakthroughs is an inherently uncertain process and the future
success of applying our technology platform to potential new drug
candidates (such as NKTR-214) is therefore highly uncertain and
unpredictable and one or more research and development programs
could fail; and (vi) certain other important risks and
uncertainties set forth in our Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on May 8, 2014. 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.
Nektar Investor
Inquiries:
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Jennifer Ruddock/Nektar
Therapeutics
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(415)
482-5585
|
Susan Noonan/SA Noonan
Communications, LLC
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(212)
966-3650
|
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Nektar Media
Inquiries:
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Karen
Bauer/MSL
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(415) 527-8912
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SOURCE Nektar Therapeutics