SAN FRANCISCO and ORLANDO, Fla., Feb. 18,
2017 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR)
today announced that positive Phase 1 clinical data for Nektar's
lead immuno-oncology agent, NKTR-214, in patients with renal cell
carcinoma (RCC) were presented at ASCO GU 2017. NKTR-214 is
an investigational immuno-stimulatory therapy designed to expand
specific cancer-fighting T cells and Natural Killer (NK) cell
abundance directly in the tumor micro-environment and increase
expression of PD-1 on these immune cells. The results were
presented by Michael Hurwitz, MD,
PhD, Assistant Professor of Medicine, Department of Medical
Oncology at Yale Cancer Center and were entitled "A Novel Immune
Agonist, NKTR-214, Increases the Number and Activity of CD8+
Tumor Infiltrating Lymphocytes in Patients with Advanced Renal Cell
Carcinoma."
"NKTR-214 resulted in dramatic increases in tumor-infiltrating
lymphocytes (TILs) and also demonstrated encouraging anti-tumor
activity, with 40% of RCC patients experiencing tumor reductions,
including one patient with a partial response," said Dr.
Mary Tagliaferri, Vice
President, Clinical Development at Nektar. "We know that
high TIL levels are correlated with clinical response and longer
survival in patients treated with checkpoint inhibitor therapies
and can be the best predictor of response. NKTR-214's unique
mechanism, favorable safety profile and clinical activity support
our combination trials of NKTR-214 with existing checkpoint
inhibitors, such as nivolumab and atezolizumab, but also with other
I-O mechanisms in development."
Clinical benefit and safety data were presented on 15 patients
from the trial with renal cell carcinoma who were treated with
single-agent NKTR-214:
- 6/15 (40%) patients with RCC had radiographic reductions in
tumor size per RECIST 1.1 on NKTR-214, including:
- 3 patients who had progressed on 1 prior tyrosine kinase
inhibitor (TKI) and had also progressed on 1 prior checkpoint
therapy
- 3 patients who had progressed on 1 prior tyrosine kinase
inhibitor (TKI) and were checkpoint therapy naïve, including 1
patient who experienced an unconfirmed partial response
(uPR)
- NKTR-214 continues to demonstrate a favorable safety and
tolerability profile with convenient, outpatient q3w or q2w
administration in all patients evaluable for safety to-date.
Immune pheno-typing was conducted and biomarkers of immune
activation were measured in patients with evaluable tumor biopsies
and blood samples. Treatment with NKTR-214 produced a robust
elevation in immune cell frequency and activation, including:
- Increase in total lymphocytes and newly proliferating (Ki67+)
CD4+ T cells, CD8+ T cells, and NK cells, with increases greater
than 50-fold observed
- Increase in CD8+ T cells of up to 10-fold in the tumor
micro-environment in patients with evaluable tumor biopsies
(pre-dose and post-dose at week 3)
- Increase in expression of cell-surface PD-1 on T cell subsets
of up to 2-fold in the tumor micro-environment
Nektar and Bristol-Myers Squibb
are collaborating to develop NKTR-214 as a potential combination
treatment regimen with Bristol-Myers Squibb's Opdivo
(nivolumab) in five tumor types and eight potential
indications. The Phase 1/2 clinical program will enroll up to 260
patients and will evaluate the potential for the combination of
Opdivo (nivolumab) and NKTR-214 to show improved and
sustained efficacy and tolerability above the current standard of
care in melanoma, kidney, triple-negative breast cancer, bladder
and non-small cell lung cancer patients. The initial
dose-escalation trial is underway with Opdivo (nivolumab)
and NKTR-214 in the indications of first-line melanoma, second-line
RCC checkpoint therapy-naïve, and second-line non-small cell lung
cancer (NSCLC) checkpoint therapy-naïve.
NKTR-214 is an experimental therapy designed to stimulate
cancer-killing immune cells in the body by targeting CD122 specific
receptors found on the surface of these immune cells, known as CD8+
effector T cells and NK cells. In preclinical studies, treatment
with NKTR-214 resulted in a rapid expansion of these cells and
mobilization into the tumor
micro-environment.1 NKTR-214 has an antibody-like
dosing regimen similar to the existing checkpoint inhibitor class
of approved medicines. A Phase 1/2 clinical study is ongoing to
evaluate single-agent NKTR-214 in cancer patients.
The ASCO GU 2017 poster can be downloaded at the following
url:
http://www.nektar.com/application/files/1414/8701/4816/2017_ASCOGU_NKTR-214-clinical_poster.pdf
About Nektar
Nektar Therapeutics has a robust
R&D pipeline and portfolio of approved partnered medicines in
oncology, pain, immunology and other therapeutic areas. In the area
of oncology, Nektar is developing NKTR-214, an
immuno-stimulatory CD122-biased agonist, that is in Phase 1/2
clinical development for patients with solid tumors. ONZEALD™
(etirinotecan pegol), a long-acting topoisomerase I inhibitor, is
being developed for patients with advanced breast cancer and brain
metastases and is partnered with Daiichi Sankyo in Europe. 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. In hemophilia, Nektar has a
collaboration agreement with Baxalta for ADYNOVATE® [Antihemophilic
Factor (Recombinant)], a longer-acting PEGylated Factor VIII
therapeutic approved in the U.S. and Japan for
patients over 12 with hemophilia A. In anti-infectives, the company
has two collaborations with Bayer Healthcare, Cipro Inhale in
Phase 3 for non-cystic fibrosis bronchiectasis and Amikacin Inhale
in Phase 3 for 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™, Baxalta's ADYNOVATE®, UCB's Cimzia® for Crohn's disease
and rheumatoid arthritis, 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.
ONZEALD™ is a trademark of Nektar Therapeutics.
Cimzia® is a trademark of UCB.
Opdivo is a registered trademark of Bristol-Myers
Squibb.
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,"continue" and similar references to future periods.
Examples of forward-looking statements include, among others,
statements we make regarding the potential safety,
tolerability, and therapeutic benefit of NKTR-214 for cancer
patients, the future clinical development plans for NKTR-214, the
potential of NKTR-214 in combination with other immunotherapy
agents including Bristol-Myers Squibb's Opdivo (nivolumab), and
certain other statements regarding the prospects and potential of
Nektar's business, technology platform and drug candidate
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) NKTR-214 is in early
stage clinical development and the risk of failure remains high and
failure can unexpectedly occur at any stage for one or more of the
cancer indications being studied prior to regulatory approval due
to lack of sufficient efficacy, safety considerations or other
factors that impact drug development; (ii) data reported from the
Phase 1 Trial is interim data only and the final results will
change based on continuing observations from patients that
currently remain enrolled in the trial (e.g., whether unconfirmed
objective responses ultimately become confirmed responses); (iii)
the Phase 1 Trial results for NKTR-214 remain subject to final data
gathering and analysis review and confirmation procedures; (iv) the
timing or success of the start or end of clinical trials such as
those planned for NKTR-214 may be delayed or unsuccessful due to
regulatory delays, clinical trial design issues, slower than
anticipated patient enrollment, drug manufacturing challenges,
changing standards of care, and clinical outcomes; (v) scientific
discovery of new medical breakthroughs is an inherently uncertain
process and the future success of the application of Nektar's
technology platform to potential new drug candidates such as
NKTR-214 is therefore very uncertain and unpredictable and one or
more research and development programs could fail; (vi) Nektar's
patent applications for NKTR-214 may not issue in one or more
jurisdictions, patents that have issued may not be enforceable, or
additional intellectual property licenses from third parties may be
required in the future; (vii) the outcome of any existing or future
intellectual property or other litigation related to Nektar's
proprietary product candidates, including, without limitation,
NKTR-214, is unpredictable and could have a material adverse effect
on our business; and (viii) certain other important risks and
uncertainties set forth in Nektar's Quarterly Report on Form 10-Q
for the quarter ended September 30,
2016 filed with the Securities and Exchange Commission on
November 4, 2016. 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:
For Investors:
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
Jodi Sievers of Nektar
Therapeutics
415-482-5593
For Media:
Dan Budwick of Pure Communications,
Inc.
973-271-6085
dan@purecommunicationsinc.com
1. Charych, D., et al., Clin
Cancer Res.; 22 (3) 2016
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SOURCE Nektar Therapeutics