Nektar Reports Positive Preclinical Data for Two Oncology Programs at 2014
SAN FRANCISCO, April 9, 2014
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.
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
"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.
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
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
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
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 theSecurities and Exchange
CommissiononFebruary 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:
Jennifer Ruddock/Nektar Therapeutics (415) 482-5585
Susan Noonan/SA Noonan Communications, LLC (212) 966-3650
Nektar Media Inquiries:
Brianne Cannon/MSL (415) 512-0770
SOURCE Nektar Therapeutics
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