SAN FRANCISCO, June 2, 2015 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ:NKTR) and The University
of Texas MD Anderson Cancer Center today announced a
research collaboration that includes a Phase 1/2 clinical study to
evaluate NKTR-214, a CD122-biased cytokine designed to
preferentially stimulate production of CD8-positive T cells, which
are tumor killing cells found naturally in the body. CD122,
which is also known as the Interleukin-2 receptor beta sub-unit, is
a key signaling receptor that is known to increase proliferation of
these effector T cells.1
"We are certain that cytokines are an essential pillar of
immunotherapy, along with checkpoint inhibitors, adoptive T cell
therapy and cancer vaccines," said Patrick
Hwu, M.D., Division Head of Cancer Medicine at MD
Anderson. "Through clinical studies, we will explore
this new cytokine's potential to preferentially activate an
established target, the IL-2 receptor beta or CD122, in order to
stimulate tumor cell killing within the tumor
microenvironment. Collaborations with industry allow MD
Anderson to pursue new treatment regimens that could dramatically
improve patient treatment in the future."
The agreement covers a Phase 1/2 study to evaluate NKTR-214 in a
variety of tumor types as a monotherapy and in combination with
other therapies, including PD-1 pathway inhibitors. Nektar
and MD Anderson expect to initiate the first dose-escalation
clinical study later this year. The two organizations will
also conduct translational research to identify predictive
biomarkers that can be used in the future development of
NKTR-214.
"Nektar is pleased to collaborate with MD Anderson, a recognized
leader in immuno-oncology, for clinical development of our lead
immunotherapy candidate, NKTR-214," said Ivan Gergel, M.D., Senior Vice President and
Chief Medical Officer of Nektar. "We believe NKTR-214 has
great potential in different tumor types, both as a single agent
and in combination with checkpoint inhibitors and other inhibiting
agents. This new alliance with MD Anderson will significantly
advance the development of NKTR-214 and help us to potentially
offer a new and important therapeutic option for cancer
patients."
In preclinical studies, NKTR-214 demonstrated a mean ratio of
450:1 within the tumor micro-environment of CD8-positive effector
T-cells, which promote tumor killing, compared with
CD4-positive regulatory T-cells, which are a type of cell that can
suppress tumor killing.2 Furthermore, although NKTR-214
is a cytokine, it is designed to be dosed on an antibody-like
schedule similar to the dosing schedules for PD-1 and CTLA-4
agents.
About NKTR-214
NKTR-214 is a CD122-biased
immune-stimulatory cytokine, which is designed to stimulate the
patient's own immune system to kill tumor cells. By biasing
activation to the CD122 receptor, NKTR-214 enhances CD8+ memory
effector T cells (tumor-killing cells) in the tumor. In preclinical
studies, a single dose of NKTR-214 resulted in a 400-fold AUC
exposure within the tumor compared with an equivalent dose of the
existing IL-2 therapy, enabling, for the first time, an
antibody-like dosing regimen for a cytokine.3 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.4 NKTR-214 is currently
completing final IND-enabling studies and is expected to begin
clinical testing in the second half of 2015.
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® 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, BAX 855, a longer-acting PEGylated Factor VIII
therapeutic is in Phase 3 development conducted by partner
Baxter. A BLA for BAX 855 was
filed by Baxter to the US FDA in
December, 2014 and is currently under review. 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 of the AstraZeneca group of
companies.
About MD Anderson
The University of Texas
MD Anderson Cancer Center in Houston ranks as one of the world's most
respected centers focused on cancer patient care, research,
education and prevention. MD Anderson is one of only 41
comprehensive cancer centers designated by the National Cancer
Institute (NCI). For the past 25 years, MD Anderson has ranked
as one of the nation's top two cancer centers in U.S. News &
World Report's annual "Best Hospitals" survey. MD Anderson
receives a cancer center support grant from the NCI of the National
Institutes of Health (P30 CA016672).
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which 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, the anticipated start of NKTR-214 clinical
studies, 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) prior to commencing clinical studies for NKTR-214, Nektar must
successfully finalize and submit an Investigational New Drug
application to the FDA and such application must become effective;
(ii) NKTR-214 is in early-stage research and there are a number of
hurdles, including the successful completion of preclinical
toxicology studies and successful manufacture of drug product,
prior to the 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 1, 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
Ryan Flinn of WCG
415-946-1059
nektar@wcgworld.com
- Boyman, J., et al., Nature Reviews Immunology, 2012, 12,
180-190.
- Charych, D., et al., Cancer Res. 2013;73(8 Suppl):Abstract nr
482 and Data on file.
- Hoch U, at al. AACR; Mol Cancer Ther. 2013;12(11
Suppl):Abstract nr B296.
- Data on file. Nektar Therapeutics.
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SOURCE Nektar Therapeutics