SAN FRANCISCO, April 9, 2014 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR), a biopharmaceutical company developing
novel therapeutics based on its PEGylation and advanced polymer
conjugation technologies, today announced that preclinical data for
NKTR-102 and NKTR-214 were presented at the 2014 Annual Meeting of
the American Association of Cancer Research (AACR) being held in
San Diego, California.
NKTR-102 Presentation
Positive preclinical data was presented for NKTR-102
(etirinotecan pegol), a novel, next-generation topoisomerase I
inhibitor, which is currently in Phase 3 development for the
treatment of advanced breast cancer. In a model of
triple-negative breast cancer with brain metastases (MDA-MB-231Br
cell line), NKTR-102 reduced the size and number of brain
metastases and also prolonged survival as compared to both placebo
and irinotecan, a first-generation topoisomerase-I
inhibitor.
"Brain tumors resulting from metastatic breast cancer are
notoriously difficult to treat because of the inability to achieve
effective concentrations of standard anti-cancer agents in these
tumors," said Paul R. Lockman, PhD.,
Chair of the Department of Basic Pharmaceutical Sciences, and the
Associate Center Director for Translational Research in the Mary
Babb Randolph Cancer Center. "These remarkable preclinical data for
NKTR-102 clearly demonstrate that the drug's extended half-life
combined with its unique molecular design allow NKTR-102 to
penetrate through leaky brain tumor vasculature and concentrate in
metastasized tumors, which results in significant tumor reduction
and prolonged survival."
NKTR-102 is currently being evaluated in the BEACON study, which
is a Phase 3, open-label, randomized, multicenter study of NKTR-102
that enrolled 852 women with locally recurrent or metastatic breast
cancer, who have previously been treated with ATC. More than
one million women worldwide are diagnosed with breast cancer
globally every year. (1) The chance of developing invasive breast
cancer at some time in a woman's life is a little less than one in
eight (12%). There are approximately 200,000 new cases of breast
cancer in the United States and
430,000 in Europe each year. (2)
Metastatic breast cancer refers to cancer that has spread from the
breast to distant sites in the body.
NKTR-214 Presentation
Positive preclinical data was also presented for NKTR-214, a
novel immunocytokine therapy that is engineered using Nektar's
polymer conjugate technology to selectively target the beneficial
IL-2 receptor complex. Preclinical data reported in murine colon
and breast tumor models showed that pre-dosing with anti-CTLA 4
followed by NKTR-214 produced complete responses in a majority of
the animals with fewer side effects than dosing either agent alone
or the combination concomitantly.
"NKTR-214 specifically enhanced CD8+ memory T cells without
increasing regulatory T cells when dosed following anti-CTLA4
therapy, which resulted in durable complete responses in aggressive
and resistant preclinical models," said Stephen Doberstein, Ph.D., Senior Vice President
and Chief Scientific Officer of Nektar Therapeutics. "The synergy
of NKTR-214 when dosed with an anti-CTLA4 therapy shows promise for
this combination in further activating the immune system to fight
tumors."
Preclinical data presentations made at the 2014 AACR can be
downloaded from Nektar's website:
Abstract #4592:
"Etirinotecan pegol accumulates in breast cancer brain
metastases and prolongs survival in an experimental model of brain
metastases of human triple negative breast cancer", Nounou et
al.
Presentation Time: Tuesday, April 8, 2014, 1:00 pm - 5:00 pm
Pacific Time
Location: Hall A-E, Poster Section 33
http://www.nektar.com/pdf/pipeline/NKTR-102/NKTR-102_AACR_Poster_01Apr2014.pdf
Abstract 5032:
"Synergy between an engineered cytokine, NKTR-214, and CTLA-4
blockade in murine colon and breast tumor models", Lee, S., et
al.
Session Date and Time: Wednesday April 9, 2014, 8:00 AM - 12:00
PM
Location: Hall A-E, Poster Section 10
http://www.nektar.com/pdf/pipeline/2014_NKTR-214_AACR_poster.pdf
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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.
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.
(1) American Cancer Society, 2007 Global Cancer Facts and
Figures Report.
(2) American Cancer Society, 2009 Global Cancer Facts and
Figures Report.
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-102, 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-102 and 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-102 and 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 Annual Report on Form 10-K
filed with the Securities and Exchange
Commission on February 27, 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
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Susan Noonan/SA
Noonan Communications, LLC
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(212)
966-3650
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Nektar Media
Inquiries:
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Brianne
Cannon/MSL
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(415)
512-0770
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SOURCE Nektar Therapeutics