SAN FRANCISCO, April 2, 2019 /PRNewswire/ -- Nektar Therapeutics
(Nasdaq: NKTR) today presented preclinical data on its
immuno-oncology pipeline candidates, bempegaldesleukin (NKTR-214 or
bempeg), a CD122-preferential IL-2 pathway agonist, and NKTR-255,
an IL-15 receptor agonist, at the American Association for Cancer
Research (AACR) Annual Meeting 2019. The meeting is being
held on March 29 to April 3, 2019 at
the Georgia World Congress Center in Atlanta.
"We're excited to showcase our promising immuno-oncology
pipeline, which is strategically developed to target multiple
points in the cancer immunity cycle to amplify the body's ability
to fight tumor cells," said Jonathan
Zalevsky, Ph.D., Chief Scientific Officer at Nektar. "The
preclinical studies presented at AACR 2019, by both Nektar
scientists and our collaborators highlight the promise of targeting
the IL-2 and IL-15 pathways to activate the immune system to induce
durable anti-tumor responses in combination with complementary
mechanisms such as personalized T cell vaccines and tumor-directed
antibody therapies. We plan to explore these combinations further
and look forward to advancing them into the clinic."
Details of the poster presentations at AACR Annual Meeting 2019
are as follows and each will be available for download at the time
of presentation at http://www.nektar.com/science/scientific-posters
or by clicking on the links below.
Abstract #2256/Poster Board #15
Title: "Combination of neoantigen DNA plasmid vaccine
VB10.NEO and NKTR-214, a CD122-biased immunostimulatory cytokine,
induces strong neoantigen-specific T cell responses and sustained
tumor regression in pre-clinical models", Granum, S., et
al.
Session: Clinical Research - Combination Immunotherapies
1
Date: Monday, April 1, 2019,
1:00 p.m. – 5:00 p.m. Eastern Time
Location: Exhibit Hall B, Poster Section 19
- VB10.NEO and bempegaldesleukin (NKTR-214) worked
synergistically to elicit greater breadth and depth of
neoantigen-specific T cell responses than each individual
treatment.
- The synergistic effect was observed in both CD4 and CD8 T
cells, and most pronounced on CD8 T cell responses, further
supporting the combination's potential to induce strong immunogenic
CD8+ T cell responses.
- VB10.NEO in combination with bempegaldesleukin (NKTR-214) and
anti-PD-1 induced rapid, complete and durable tumor regression of
small tumors and long-lasting stabilization of large tumors
supporting the rationale for examining the combination
clinically.
Abstract #3265/Poster Board #15
Title: "NKTR-255, a polymer-conjugated IL-15
enhances anti-tumor NK cell responses and synergizes with
monoclonal antibodies to provide long-term survival in human
lymphoma model", Miyazaki, T., et al.
Session: Immunology - Novel Immunomodulatory Agents 1
Date: Tuesday, April 2, 2019,
8:00 a.m. – 12:00 p.m. Eastern
Time
Location: Exhibit Hall B, Poster Section 25
- NKTR-255 showed a dose-dependent effect on the proliferation
and activation of natural killer (NK) cells.
- NKTR-255 enhanced the therapeutic efficacy of antibodies,
daratumumab or rituximab.
- Combining NKTR-255 with a tumor-directed antibody with an
antibody dependent. cellular cytotoxicity (ADCC) mechanism may
provide a synergistic effect for treating cancers.
Abstract #3210/Poster Board #20
Title: "A potential immunotherapeutic approach for the
treatment of osteosarcoma", Wahba, A., et al.
Session: Immunology – Combination Immunotherapies 2
Date: Tuesday, April 2, 2019,
8:00 a.m. – 12:00 p.m. Eastern Time
Location: Exhibit Hall B, Poster Section 23
- In an osteosarcoma mouse model, bempegaldesleukin (NKTR-214)
monotherapy was shown to be effective in controlling the growth of
primary tumor, regrowth of tumor after amputation and inhibition of
lung metastasis.
- Bempegaldesleukin (NKTR-214) increased the migration of CD8,
CD4 and F4/80+ cells to the tumor.
- Administering an anti-PD1 checkpoint inhibitor alone or in
combination with bempegaldesleukin (NKTR-214) did not augment the
anti-tumor response.
About bempegaldesleukin (NKTR-214)
Bempegaldesleukin is an investigational, first-in-class,
CD122-preferential IL-2 pathway agonist designed to provide rapid
activation and proliferation of cancer-killing immune cells, known
as CD8+ effector T cells and natural killer (NK) cells, without
over activating the immune system. Bempegaldesleukin stimulates
these cancer-killing immune cells in the body by targeting CD122
receptors found on the surface of these immune cells. CD122, which
is also known as the Interleukin-2 receptor beta subunit, is a key
signaling receptor that is known to increase proliferation of these
effector T cells.1 In clinical and preclinical studies,
treatment with bempegaldesleukin resulted in expansion of these
cells and mobilization into the tumor
micro-environment.2,3 Bempegaldesleukin has an
antibody-like dosing regimen similar to the existing checkpoint
inhibitor class of approved medicines.
About NKTR-255
NKTR-255 is an IL-15 receptor agonist designed to engage the IL-15
pathway to stimulate and expand natural killer (NK) cells and
promote the survival and expansion of central memory CD8+ T cells
without inducing suppressive regulatory T cells. Through optimal
engagement of the IL-15Rα/IL-2Rγ receptor complex, NKTR-255
enhances formation of long-term immunological memory which may lead
to sustained anti-tumor immune response. Native rhIL-15 is rapidly
cleared from the body and must be administered frequently and in
high doses limiting its utility due to toxicity. NKTR-255 is
designed with IL-15 receptor alpha specificity to optimize
biological activity and is uniquely engineered to provide optimal
exposure and an improved safety profile.
About VB10.NEO
VB10.NEO, is a proprietary therapeutic DNA vaccine which uses the
patient's own neoantigens for the personalized treatment of cancer
patients. In September 2018, Nektar
and Vaccibody entered into a clinical collaboration to evaluate
bempegaldesleukin in combination with VB10.NEO. A pilot study
evaluating the combination in patients with squamous cell carcinoma
of the head and neck is planned to begin mid-2019.
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 our 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 Nektar 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: "will," "may," "planned,"
"promise," "designed," "develop" and similar references to future
periods. Examples of forward-looking statements include, among
others, statements we make regarding the therapeutic potential of
bempegaldesleukin and NKTR-255 (alone or in combination with other
agents, such as bempegaldesleukin in combination with VB10.NEO),
the future development plans of bempegaldesleukin and NKTR-255, and
the availability of results and outcomes from our clinical and
preclinical studies. 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, 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 bempegaldesleukin alone, NKTR-255 alone,
and bempegaldesleukin in combination with VB10.NEO are each based
on preclinical findings studies and future data generated from new
studies may be materially different; (ii) bempegaldesleukin,
NKTR-255 and VB10.NEO are in early stage 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 negatively impact drug
development; (iii) the timing of the commencement and end of
clinical studies and the availability of clinical data may be
delayed due to regulatory delays, slower than anticipated patient
enrollment, manufacturing challenges, changing standards of care,
evolving regulatory requirements, clinical trial design, or
clinical outcomes; (iv) scientific discovery of new medical
breakthroughs is an inherently uncertain process and the future
regulatory approval of potential new drug candidates (such as
bempegaldesleukin, NKTR-255 and VB10.NEO) is therefore very
uncertain and unpredictable; (v) patents may not issue from our
patent applications for our drug candidates, 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 Nektar's Annual
Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and
Exchange Commission on March 1, 2019.
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
or
Ashleigh Barreto of Nektar
Therapeutics
628-895-0694
For Media:
Dan Budwick of 1AB
973-271-6085
dan@1abmedia.com
1 Boyman, J., et al., Nature Reviews Immunology,
2012, 12, 180-190
2 Charych, D., et al., Clin
Can Res; 22(3) February 1,
2016
3 Diab, A., et al., Journal for ImmunoTherapy of
Cancer 2016, 4(Suppl 1): P369
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