Nektar Presents Target-Specific Biomarkers Being Assessed in Ongoing Phase 3 BEACON Study of Etirinotecan Pegol for the

 Nektar Presents Target-Specific Biomarkers Being Assessed in Ongoing Phase 3
  BEACON Study of Etirinotecan Pegol for the Treatment of Metastatic Breast
   Cancer at the 2013 American Society of Clinical Oncology Annual Meeting

PR Newswire

CHICAGO and SAN FRANCISCO, June 1, 2013

CHICAGO and SAN FRANCISCO, June 1, 2013 /PRNewswire/ -- Nektar Therapeutics
(NASDAQ:NKTR) announced today that it presented a series of target-specific
biomarkers that are being evaluated in the development of etirinotecan pegol
for the treatment of breast cancer. Etirinotecan pegol is a unique, next
generation, targeted topoisomerase I inhibitor currently in Phase 3 clinical
development as a potential treatment for patients with locally recurrent or
metastatic breast cancer. The BEACON (BrEAst Cancer Outcomes with NKTR-102)
Phase 3 Study is a randomized, open-label, international study that is
evaluating single agent etirinotecan pegol in patients who have previously
received an anthracycline, a taxane and capecitabine (ATC) versus a comparator
arm consisting of an active single agent treatment of physician's choice
(TPC).

"One of our objectives in treating metastatic breast cancer is to
prospectively identify patients that will respond to specific treatments so
they can achieve the optimal individualized care," said Hope Rugo, M.D.,
Director of Breast Oncology andClinical Trials Educationat the UCSF Helen
Diller Comprehensive Cancer Center and Member of the BEACON Study investigator
steering committee. "The goal of evaluating these important biomarkers in
patients enrolled into the BEACON study is to help us understand which breast
cancer patients might have the best clinical outcomes from treatment with
etirinotecan pegol."

A series of assays for target-specific pharmacodynamic biomarkers for
etirinotecan pegol, including the molecular target topoisomerase I, have been
established and are being measured in the Phase 3 BEACON study. The
biomarkers were identified from Circulating Tumor Cell (CTC) samples which
were collected prior to patient treatment. Additional CTC patient samples are
being collected at regular intervals during treatment and at the end of
treatment. Preliminary results from the initial pre-dose samples found CTCs
in over 90% of patient samples, with a median of 200 CTCs per 7.5 mL blood
draw. Patient participation in the CTC sub-set of the BEACON study is
projected to be over 75%. Measurements of each biomarker expression over time
will be analyzed in order to identify potential predictive biomarkers for
clinical response to etirinotecan pegol.

"We are pleased to have identified several baseline pharmacodynamic
biomarkers, which are target-specific such as topoisomerase 1, and which can
be reliably measured over the patient's treatment period," said Robert Medve,
M.D., Chief Medical Officer of Nektar Therapeutics. "The measurement of these
biomarkers in the BEACON study will help us understand and shape the future
treatment of patients with etirinotecan pegol. Enrollment in the BEACON study
is well ahead of schedule and we expect to complete the target enrollment of
840 patients in the third quarter of 2013."

Circulating Tumor Cellsare cancer cells shed from either the primary tumor or
its metastases that circulate in the peripheral blood. CTCs are emerging tumor
biomarkers, collected through a minimally invasive blood draw, providing a
"liquid" biopsy sample and allowing for post-treatment monitoring of the
patient. CTCs provide well-defined targets for the understanding of tumor
biology and tumor cell dissemination, which offers a unique approach to
identify novel therapeutic targets and understand resistance to established
therapies.^1 

2013 ASCO Presentation Details for Etirinotecan Pegol:
Abstract Title: "Etirinotecan pegol (EP) target-specific pharmacodynamic (PD)
biomarkers measured in circulating tumor cells (CTCs) isolated from patients
participating in BEACON, a Phase 3 study in patients with metastatic breast
cancer (mBC)", Hoch et al.

     oAbstract Number: 1087
     oSession Title/Track: Breast Cancer — Triple-Negative/Cytotoxics/Local
       Therapy
     oDate: June 1, 2013, 1:15 p.m. — 5:00 p.m. Central Time
     oLocation: S Hall A2

About the BEACON Study
The BEACON (BrEAst Cancer Outcomes with NKTR-102) Study is a phase 3
randomized, open-label, international study of etirinotecan pegol in patients
with metastatic breast cancer that is evaluating single agent etirinotecan
pegol in patients who have previously received an anthracycline, a taxane and
capecitabineversus a comparator arm consisting of an active single agent
treatment of physician's choice. The physician's choice agents will include:
ixabepilone, vinorelbine, gemcitabine, eribulin, or a taxane.

The primary endpoint of the BEACON study is overall survival, and secondary
endpoints include progression-free survival and objective tumor response rates
(ORR). Secondary endpoints also include clinical benefit rate, duration of
response, PK data, safety profiles, quality-of-life measurements, and
pharmacoeconomic implications. Exploratory objectives of the study also
include collecting specific biomarker data to correlate with objective tumor
response rates, progression-free survival, overall survival and selected
toxicities.

About Etirinotecan Pegol (NKTR-102)
Etirinotecan pegol is a unique, targeted topoisomerase I inhibitor designed
for prolonged tumor cell exposure. Etirinotecan pegol is believed to penetrate
the vasculature of the tumor environment more readily than normal vasculature,
increasing the concentration of active drug within tumor tissue to enhance
anti-tumor activity. The BEACON study is a Phase 3 clinical study currently
evaluating etirinotecan pegol for the treatment of locally recurrent or
metastatic breast cancer. In addition to metastatic breast cancer,
etirinotecan pegol is also being evaluated for the treatment of ovarian,
colorectal, glioma and non-small cell lung cancers.

About Nektar
Nektar Therapeutics 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 completed Phase 3 development 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 candidate for
chronic pain conditions, is in Phase 2 development in osteoarthritis patients
with chronic knee pain. NKTR-192, a novel mu-opioid analgesic in development
to treat acute 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 and colorectal 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.

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. 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 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 etirinotecan pegol
for women with locally recurring or metastatic breast cancer, the predictive
potential of prospectively measured biomarkers in the BEACON study to
potentially identify patients more likely to benefit from etirinotecan pegol,
the projected percentage of patients participating in the CTC sub-set of the
BEACON clinical study, the projected timeframe in which we expect the BEACON
clinical study to be fully enrolled, and the value and 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) the prospectively measured biomarkers
have not previously been linked to more positive clinical outcomes for
metastatic breast cancer patients receiving etirinotecan pegol therapy; (ii)
etirinotecan pegol is in clinical development and the risk of failure is high
and can unexpectedly occur at any time prior to regulatory approval for
numerous reasons including safety and efficacy findings in the BEACON study;
(iii) the statements regarding the therapeutic potential of etirinotecan pegol
are based on preclinical data and data from the completed Phase 2 clinical
study and the future results from the BEACON clinical study may not confirm
these earlier findings; (iv) 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; (v) 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; 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 9, 2013. 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:  
Karen Bauer                                               (415) 817-2549
Mike Huckman                                              (646) 500-7631

1. LianidouES,et al.,What's new on circulating tumor cells? A meeting
report.Breast Cancer Res2010;12:307.

SOURCE Nektar Therapeutics

Website: http://www.nektar.com
 
Press spacebar to pause and continue. Press esc to stop.