SAN FRANCISCO, Nov. 7, 2017 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced that new clinical data
will be presented for NKTR-214, Nektar's lead immuno-oncology
candidate, a CD122-biased agonist, at the Society for Immunotherapy
of Cancer (SITC) Annual Meeting at the Gaylord National Hotel &
Convention Center in National Harbor, Maryland. Data from the
ongoing PIVOT Phase 1/2 study, which is evaluating NKTR-214 in
combination with the checkpoint inhibitor nivolumab, will be
presented in an oral presentation on Saturday, November 11th.
Six additional presentations for immuno-oncology (I-O) candidates
in Nektar's pipeline will also be presented at the meeting;
specifically, one additional clinical and three preclinical
presentations on NKTR-214; one preclinical presentation on
NKTR-255, an IL-15 memory T-cell stimulating cytokine; and one
preclinical presentation on NKTR-262, a novel toll-like receptor
(TLR) agonist. The abstracts published in advance of the SITC
Annual Meeting were made available at 8 a.m.
Eastern Time today on the Journal for ImmunoTherapy of
Cancer's website at
https://www.sitcancer.org/2017/abstracts/titles.
"The initial abstract data for these first set of 16 patients
from the PIVOT study evaluating NKTR-214 in combination with
nivolumab is very exciting," said Mary Tagliaferri, M.D., Senior Vice President of
Clinical Development at Nektar Therapeutics. "We look forward
to presenting additional new data from all of the 38 patients
enrolled in the dose escalation cohort of the study in Dr. Diab's
oral presentation at SITC on Saturday afternoon, including the
first efficacy data for patients with PD-L1 negative non-small cell
lung cancer who had progressed on prior chemotherapy. We believe
there is tremendous need for more efficacious and better tolerated
I-O combination treatment regimens, particularly treatments that
can be used for the majority of cancer patients whose tumors don't
express PD-L1 as these patients can't currently benefit from
treatment with checkpoint inhibitors."
NKTR-214 is an investigational immuno-stimulatory therapy
designed to expand specific cancer-fighting CD8+ effector T cells
and natural killer (NK) cells directly in the tumor
micro-environment and increase expression of PD-1 on these immune
cells.
Details of the SITC presentations for Nektar's I-O portfolio are
below.
Oral Presentation
Date: Saturday, November 11,
2017, Presentation Time: 5:00 p.m. Eastern Time
Session Title: Clinical Trials: Novel Combinations
Presentation Title: PIVOT-02: Preliminary safety,
efficacy and biomarker results from the Phase 1/2 study of
CD-122-biased agonist NKTR-214 plus nivolumab in patients with
locally advanced/metastatic solid tumors
Presenter: Dr. Adi Diab, MD Anderson Cancer
Center
Location: Gaylord National Hotel & Convention Center,
Maryland Ballroom A
The online abstract for the oral clinical presentation includes
preliminary data as of July 25, 2017
for 16 patients with Stage IV melanoma and renal cell carcinoma
enrolled in the dose-escalation phase of the PIVOT study of
NKTR-214 in combination with nivolumab (NCT02983045). New and
updated interim data for a total of 38 patients with Stage IV
melanoma, renal cell carcinoma and non-small cell lung cancer which
were enrolled in the dose-escalation phase of the PIVOT study, will
be presented at the SITC Annual Meeting. A copy of the slides
from Dr. Diab's presentation will be made available on Nektar's
corporate website on Saturday, November
11th at 6:00 p.m. Eastern
Time, in accordance with the embargo policies set forth by
SITC.
Poster Presentations
Biomarkers and Immune Monitoring
Clinical Data Abstract #P77: The Novel IL-2
Cytokine Immune Agonist NKTR-214 Harnesses the Adaptive and Innate
Immune System for the Treatment of Solid
Cancers
Presenter: Salah Eddine Bentebibel,
University of Texas MD Anderson Cancer
Center
Date and Time: Friday, November
10, 2017, 12:30-2:00 p.m. Eastern
Time
Cancer Vaccines
Preclinical Data Abstract #P140: NKTR-214
enhances anti-tumor T-cell immune responses induced by checkpoint
blockade or vaccination
Presenter: Meenu Sharma,
University of Texas MD Anderson Cancer
Center
Date and Time: Saturday,
November 11, 2017, 12:30-2:00 p.m.
Eastern Time
Combination Therapy
Preclinical Data Abstract
#P274: Combination of NKTR-214 and
radiotherapy (RT) to reverse anergy and expand tumor-specific CD8 T
Cells
Presenter: Joshua
Walker, Oregon Health & Science University
Date and Time: Saturday,
November 11, 2017,12:30-2:00 p.m. Eastern Time
Preclinical Data Abstract #P275: Harnessing the
innate and adaptive immune system to eradicate treated and distant
untreated solid tumors
Presenter: Saul Kivimae,
Nektar Therapeutics
Date and Time: Friday, November
10, 2017, 12:30-2:00 p.m. Eastern
Time
Immune Modulation, Cytokines, and Antibodies
Preclinical Data Abstract #P332: Pre-clinical
efficacy and tolerability of NKTR-255, a polymer-conjugated IL-15
for immuno-oncology
Presenter: Peiwen Kuo,
Nektar Therapeutics
Date and Time: Saturday, November 11,
2017, 12:30-2:00 p.m. Eastern
Time
Personalized Vaccines and Technologies/Personalized
Medicines
Preclinical Data Abstract #P434: Great Apes
Adenoviral vaccine encoding neoantigens synergizes with
immunomodulators to cure established tumors in mice
Presenter: Anna Morena D'Alise, Nouscom srl
Date and Time: Saturday, November 11,
2017, 12:30-2:00 p.m. Eastern
Time
Analyst and Investor Event
Nektar Therapeutics will
webcast an analyst and investor event with clinical investigators
during the SITC Annual Meeting beginning on Saturday, November 11, 2017 at 6:15 p.m. Eastern Time. Featured speakers include
Dr. Patrick Hwu of MD Anderson
Cancer Center, Dr. Adi Diab of MD
Anderson Cancer Center, Dr. Michael E.
Hurwitz of Yale Cancer Center, Dr. Antoni Ribas of UCLA Medical Center and Dr.
Nizar M. Tannir of MD Anderson
Cancer Center. The webcast is accessible from the investor
relations page of Nektar's website at www.nektar.com.
About NKTR-214
NKTR-214 is a clinical-stage,
immuno-stimulatory therapy designed to expand specific
cancer-fighting CD8+ effector T cells and natural killer (NK) cells
directly in the tumor micro-environment and increase expression of
PD-1 on these immune cells. NKTR-214 is a CD122-biased IL-2 pathway
agonist that targets cancer-fighting immune cells to stimulate
their proliferation and activation. In clinical and
preclinical studies, treatment with NKTR-214 resulted in expansion
of these cells and their mobilization into the
tumor.1,2 NKTR-214 has an antibody-like dosing
regimen similar to the existing checkpoint inhibitor class of
approved medicines.
About NKTR-255
NKTR-255 is an immune-stimulating
cytokine designed to engage all three IL-15 receptors and signal
through all of these to activate the IL-15 pathway. NKTR-255
stimulates proliferation and survival of Natural Killer (NK) Cells,
CD8+ T Cells and enhances long-term immunological memory which may
lead to sustained anti-tumor immune response.
About NKTR-262
NKTR-262 is a first-in-class
investigational small molecule intended to target toll-like
receptors (TLRs) on innate immune cells in the body. NKTR-262 is
designed to overcome the body's dysfunction of antigen-presenting
cells (APC), and is being developed as a single intra-tumoral
injection to be administered at the start of therapy with NKTR-214
to induce an abscopal response and achieve the goal of complete
tumor regression in cancer patients treated with both
therapies.
About Nektar
Nektar Therapeutics is a
research-based, development stage biopharmaceutical company whose
mission is to discover and develop innovative medicines to address
the unmet medical needs of patients. Our R&D pipeline of new
investigational medicines includes treatments for cancer,
autoimmune disease and chronic pain. We leverage Nektar's
proprietary and proven chemistry platform in the discovery and
design of our new therapeutic candidates. 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 www.nektar.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains
forward-looking statements which can be identified by words such
as: "intend," "design," "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 immuno-oncology agents
(such as NKTR-214, both alone and in combination with one or more
other agents), the anticipated need for immuno-oncology
combinations (such as NKTR-214 in combination with anti-PD1 and
anti-PD-L1 agents) for use in patients whose tumors do not express
PD-L1, and the potential of our technology and immuno-oncology drug
candidates (such as NKTR-214, NKTR-255 and NKTR-262) 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) our statements regarding the
therapeutic potential of our immuno-oncology agents (such as
NKTR-214, NKTR-255 and NKTR-262) are based on findings and
observations from preclinical findings and, in some cases, ongoing
clinical studies; (ii) NKTR-214, both alone and in combination with
other agents (such as anti-PD1 and anti-PD-L1 agents) and our other
immuno-oncology agents are in early stages of development and the
risk of failure remains high and failure can unexpectedly occur due
to efficacy, safety or other unpredictable factors prior to
regulatory approval for numerous reasons, including negative safety
and efficacy findings even after positive findings in previous
clinical and preclinical studies; (iii) the timing of the
commencement or end of clinical studies and the availability of
clinical data 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; (iv) 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, NKTR-255 and
NKTR-262) is therefore highly uncertain and unpredictable and one
or more research and development programs could fail; (v) patents
may not issue from our patent applications for our immuno-oncology
drug candidates (including NKTR-214, NKTR-255 and NKTR-262),
patents that have issued may not be enforceable, or additional
intellectual property licenses from third parties may be required;
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 August 9, 2017. 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:
Jennifer Paganelli
347-658-8290
jpaganelli@purecommunications.com
- Charych, D., et al., Cancer Res. 2013;73(8 Suppl):Abstract nr
482 and Data on file. 2.
- Hoch U, at al. AACR; Mol Cancer Ther. 2013;12(11
Suppl):Abstract nr B296.
- PD-L1 = Expression of the programmed death-1 (PD-1) ligand 1
(PD-L1) is used to select patients and analyze responses to
anti–PD-1/L1 antibodies. Ribas et. al. JEM Dec 2016
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SOURCE Nektar Therapeutics