SAN FRANCISCO, Sept. 21, 2015 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ: NKTR) today announced positive preclinical
results for NKTR-214, a CD122-biased cytokine designed to
preferentially stimulate the production and maintenance of
tumor-killing T cells which are found naturally in the body. CD122,
which is also known as the Interleukin-2 receptor beta subunit, is
a key signaling receptor that is known to increase the
proliferation of CD8-positive effector T cells, and these
CD8-positive T cells comprise a key component of the tumor
infiltrating lymphocytes that provide cell-mediated anti-tumor
effects.1
Results were presented this past Friday at the Inaugural
CRI-CIMT-EATI-AACR Immunotherapy Conference in New York. NKTR-214 shows efficacy in multiple
preclinical models as a single agent. Combination regimens with
NKTR-214 and either anti-CTLA4 or anti-PD-1 checkpoint inhibitor
therapies resulted in durable anti-tumor immunotherapeutic effects,
which persisted long after the termination of dosing.
"We are very encouraged by these remarkable preclinical
findings, which show an immune-educating vaccine-like effect with
the combination and sequencing of NKTR-214 and checkpoint
inhibition," said Stephen Doberstein, Ph.D., Senior Vice
President and Chief Scientific Officer of Nektar Therapeutics.
"This is the ultimate goal of immune-oncology and we look forward
to initiating our planned Phase 1/2 clinical trial of NKTR-214 in
the fourth quarter of 2015."
In a preclinical tumor re-challenge study presented, sequential
dosing of anti-CTLA-4 followed by NKTR-214 resulted in durable and
complete responses. At 142 days following the final dose,
with no additional treatment, the complete responders demonstrated
sustained resistance to multiple tumor re-challenges.
In highly-resistant established melanoma tumor models, data
presented show that treatment with NKTR-214 resulted in a
controlled, sustained and biased T-cell activating signal and a
mean ratio of CD8-positive T cells to T-regulatory cells ratio of
450:1 in the tumor infiltrating lymphocytes.
NKTR-214 Preclinical Data Presentation
The
presentation entitled, "Antitumor activity of NKTR-214, a
CD122-biased immunostimulatory cytokine, combined with immune
checkpoint blockade requires innate and adaptive immunity,"
which was presented at The Inaugural International Cancer
Immunotherapy Conference: Translating Science into Survival by
CRI-CIMT-EATI-AACR can be accessed at
http://www.nektar.com/product_pipeline/oncology_nktr-214.html
About NKTR-214
NKTR-214 is a CD122-biased immune-stimulatory cytokine, which is
designed to stimulate the patient's own immune system to eliminate
cancer cells. By biasing activation to the CD122 receptor,
NKTR-214 enhances CD8-positive T cells (tumor-killing cells) in the
tumor. In preclinical studies, a single dose of NKTR-214 resulted
in an approximate 400-fold AUC exposure within the tumor compared
with an equivalent dose of aldesleukin, an existing IL-2
therapy. This increase potentially enables, for the first
time, an antibody-like dosing regimen for a
cytokine.2 In dosing studies in non-human primates,
there was no evidence of low blood pressure or vascular leak
syndrome with NKTR-214 at predicted clinical therapeutic
doses.3
About Nektar
Nektar Therapeutics has a robust R&D pipeline in pain,
oncology, hemophilia and other therapeutic areas. In the area of
pain, Nektar has an exclusive worldwide license agreement with
AstraZeneca for MOVANTIK™ (naloxegol), the first FDA-approved
once-daily oral peripherally-acting mu-opioid receptor antagonist
(PAMORA) medication for the treatment of opioid-induced
constipation (OIC), in adult patients with chronic, non-cancer
pain. The product is also approved in the European Union as
MOVENTIG® (naloxegol) and is indicated for adult patients with OIC
who have had an inadequate response to laxatives. The AstraZeneca
agreement also includes NKTR-119, an earlier stage development
program that is a co-formulation of MOVANTIK and an opioid.
NKTR-181, a wholly-owned mu-opioid analgesic molecule for chronic
pain conditions, is in Phase 3 development. NKTR-171, a
wholly-owned new sodium channel blocker being developed as an oral
therapy for the treatment of peripheral neuropathic pain, is in
Phase 1 clinical development. In hemophilia, ADYNOVATE™
[Antihemophilic Factor (Recombinant)], a longer-acting PEGylated
Factor VIII therapeutic has been filed for approval in the U.S. by
partner Baxalta Inc. 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.
Nektar's technology has enabled nine approved products in the
U.S. or Europe through
partnerships with leading biopharmaceutical companies, including
AstraZeneca's MOVANTIK™, 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.
MOVANTIK™ is a trademark and MOVENTIG® is a registered trademark
of the AstraZeneca group of companies.
ADYNOVATE is a trademark of Baxalta Inc.
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 based on
preclinical findings and the value and potential of our technology
and 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 clinical trials; (ii) 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;
(iii) the timing of the commencement or end of clinical trials and
the commercial launch of 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; (iv) scientific discovery of new medical breakthroughs is
an inherently uncertain process and the future success of the
application of our technology platform to potential new drug
candidates is therefore highly uncertain and unpredictable and one
or more research and development programs could fail; (v) patents
may not issue from our patent applications for our drug candidates
including NKTR-214, patents that have issued may not be
enforceable, or additional intellectual property licenses from
third parties may be required; and (vii) the outcome of any
existing or future intellectual property or other litigation
related to our drug candidates and those of our collaboration
partners. Other important risks and uncertainties set forth
in our Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on August 6,
2015. 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:
Investors
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
Media
Nadia Hasan of WCG
212-257-6738
1. Boyman, J., et al., Nature Reviews Immunology, 2012, 12,
180-190.
2. Hoch U, at al. AACR; Mol Cancer Ther. 2013;12(11 Suppl):Abstract
nr B296.
3. Data on file. Nektar Therapeutics
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