SAN FRANCISCO, Sept. 20, 2017 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced that new data across
its wholly-owned immuno-oncology (I-O) portfolio will be presented
at the upcoming Society for Immunotherapy of Cancer (SITC) Annual
Meeting, which is being held from November
10 to November 12, 2017, at the Gaylord National Hotel &
Convention Center in National Harbor, Maryland. Seven
abstracts were selected for presentation for three Nektar I-O
pipeline programs: NKTR-214, a CD122-biased agonist; NKTR-255, an
IL-15 memory T cell stimulating cytokine; and NKTR-262, a novel
toll-like receptor (TLR) agonist.
Clinical data from the PIVOT program evaluating NKTR-214 in
combination with the checkpoint inhibitor nivolumab were accepted
for an oral presentation in the Clinical Trials: Novel Combinations
Session on November 11, 2017. The
PIVOT trial is comprised of two stages, the dose-escalation stage
(PIVOT-02, n=38) and the expansion cohort stage (PIVOT-04,
n=250). The dose-escalation stage, which has completed
enrollment, is evaluating NKTR-214 in combination with nivolumab in
I-O therapy-naïve patients with melanoma, renal cell carcinoma and
non-small cell lung cancer. The expansion cohort stage, which
is actively enrolling patients, is evaluating NKTR-214 in
combination with nivolumab in five tumor types and eight different
indications. PIVOT is being conducted in a collaboration with
Bristol-Myers Squibb with each company equally sharing costs of the
combination therapy trials and Nektar maintaining its global
commercial rights to NKTR-214.
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. NKTR-214 targets CD122 specific receptors found on the
surface of cancer-fighting immune cells in order to stimulate their
proliferation and activation. In clinical and preclinical
studies, treatment with NKTR-214 resulted in expansion of these
cells and mobilization into the tumor.1,2 NKTR-214
has an antibody-like dosing regimen similar to the existing
checkpoint inhibitor class of approved medicines.
Nektar is also enrolling a separate clinical trial (the PROPEL
study) to evaluate NKTR-214 in combination with two additional
checkpoint inhibitors (atezolizumab and pembrolizumab).
Details of the oral presentation of clinical data from the
PIVOT-02 study are as follows:
Abstract 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
Session Title, Date and Time: Clinical Trials: Novel
Combinations, Saturday, November 11,
2017, 3:30 – 6:00 p.m. Eastern
Time
Six abstracts were accepted for presentation in the following
categories:
Biomarkers and Immune Monitoring
Data presentation for the clinical trial of single-agent
NKTR-214 in patients with advanced solid tumors:
- Bentebibel, S., et al., "The novel IL-2 cytokine immune
agonist NKTR-214 harnesses the adaptive and innate immune system
for the treatment of solid cancers."
Cancer Vaccines
Data presentation for preclinical studies of NKTR-214 in
combination with checkpoint blockade therapy or peptide-based
vaccination:
- Sharma, M., et al., "NKTR-214 enhances anti-tumor T cell
immune responses induced by checkpoint blockade or
vaccination."
Combination Therapy
Data presentation for preclinical studies of NKTR-214 in
combination with NKTR-262, a novel small molecule agonist that
targets toll-like receptors (TLRs) found on innate immune cells in
the body:
- Kivimae, S., et al., "Harnessing the innate and adaptive
immune system to eradicate treated and distant untreated solid
tumors."
Data presentation for preclinical studies of NKTR-214 with
high-dose radiotherapy:
- Walker, J, et al., "Combination of NKTR-214 and radiotherapy
(RT) to reverse anergy and expand tumor-specific CD8 T
Cells."
Immune Modulation, Cytokines, and Antibodies
Data presentation for preclinical studies of NKTR-255, a memory
T cell stimulating cytokine designed to engage the IL-15 pathway to
induce long-term T cell activation and improve the quality of T
cell memory response to treat cancer:
- Kirk, P, et al., "Preclinical efficacy and tolerability of
NKTR-255, a polymer-conjugated IL-15 for immuno-oncology."
Personalized Vaccines and Technologies/Personalized
Medicines
Data presentation for preclinical studies of NKTR-214 with novel
neoantigens vaccine:
- D'Alise, A.M., et al., "Great apes adenoviral vaccine
encoding neoantigens synergizes with immunomodulators to cure
established tumors in mice"
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,
auto-immune 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 http://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," "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-214, both alone
and in combination with one or more other agents (such as anti-PD1
and anti-PD-L1 agents), the synergistic activities of combinations
of active agents (such as NKTR-214 in combination with anti-PD1 and
anti-PD-L1 agents), 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) our statements regarding the
therapeutic potential of NKTR-214 are based on findings and
observations from preclinical findings and ongoing clinical
studies; (ii) NKTR-214, both alone and in combination with other
agents (such as anti-PD1 and anti-PD-L1 agents), is in early stages
of clinical 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) 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 drug candidates
including NKTR-214, 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., Clin Can Res; 22(3) February 1,
2016
- Diab, A., et al., Journal for ImmunoTherapy of
Cancer 2016, 4(Suppl 1):P369
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SOURCE Nektar Therapeutics