SAN FRANCISCO, Oct. 16, 2019 /PRNewswire/ -- Nektar Therapeutics
(NASDAQ: NKTR) today announced the initiation of a first-in-human,
Phase 1 clinical study evaluating NKTR-255, an interleukin-15
(IL-15) receptor agonist, as monotherapy for patients with relapsed
or refractory non-Hodgkin lymphoma (NHL) or multiple myeloma (MM).
The study will also combine NKTR-255 with multiple targeted
antibodies, that function through an antibody-dependent
cell-mediated cytotoxicity (ADCC) mechanism, to evaluate the safety
and efficacy in adults with relapsed or refractory MM. NKTR-255 is
designed to activate the IL-15 pathway and expand functionally
superior natural killer (NK) cells and promote the survival and
expansion of memory CD8+ T cells without inducing suppressive
regulatory T cells.
"We are excited to launch the first-in-human clinical study of
NKTR-255, which has shown promising and substantial anti-tumor
activity in our preclinical studies," said Wei Lin, M.D., Senior Vice President and Head of
Development at Nektar Therapeutics. "By increasing the number and
activity of NK cells, NKTR-255 has the potential to enhance the
host's tumor-fighting response, both as a single agent and in
combination with tumor-targeting antibodies, including daratumumab
and rituximab."
One of the big challenges in treating cancer patients with
targeted monoclonal antibodies is that the cancer patients have a
deficiency in key effector cells like NK cells that are needed to
work with the monoclonal antibodies.1,2 In nonclinical
studies, NKTR-255 exhibited anti-tumor activity and substantially
enhanced in vivo proliferation and activation of NK cells to
provide sustained cytotoxic function.3 In a preclinical
lymphoma model where single agent daratumumab was ineffective,
NKTR-255 treatment, in combination with daratumumab, increased NK
cell numbers and activity in bone marrow tissue and enhanced
ADCC-mediated tumor cell clearance in the bone marrow
compartment.4
NHL is one of the most common cancers in the United States, accounting for about 4% of
all cancers. The American Cancer Society estimates that in 2019,
approximately 74,200 people will be diagnosed with NHL in the U.S.
and about 19,970 will die from this cancer. MM is a relatively
uncommon cancer in the U.S., with a lifetime risk of getting MM of
1 in 132 (0.76%). The American Cancer Society estimates that in
2019, approximately 32,110 people will be diagnosed with MM and
about 12,960 will die from this disease.
About the NKTR-255 Phase 1 Study
The NKTR-255 Phase 1
study is an open-label, dose escalation and dose expansion study in
patients with select hematological malignancies (relapsed or
refractory NHL or MM). The dose escalation phase of the study will
evaluate the safety and tolerability of NKTR-255 as monotherapy in
approximately 40 patients in order to establish a recommended Phase
2 dose (RP2D) for NKTR-255. The dose expansion phase of the study
will enroll in two separate cohorts: the first cohort will enroll
patients with MM or NHL (relapsed salvage) to evaluate the NKTR-255
RP2D as a monotherapy and the second cohort will enroll patients
with MM or NHL (relapsed/refractory salvage) to evaluate the
NKTR-255 RP2D in combination with targeted antibodies, including
anti-CD38 monoclonal antibody, daratumumab. The study will also
evaluate pharmacokinetic and pharmacodynamic effects, anti-tumor
activity and biomarker assessments.
About NKTR-255
NKTR-255 is an IL-15 receptor agonist
designed to activate the IL-15 pathway and expand NK cells and
promote the survival and expansion of memory CD8+ T cells without
inducing suppressive regulatory T cells. Through optimal engagement
of the IL-15Rα/IL-2Rβγ receptor complex,
NKTR-255 enhances formation of long-term immunological memory,
which may lead to sustained anti-tumor immune response. NKTR-255 is
uniquely designed to overcome the challenges of recombinant IL-15,
which is rapidly cleared from the body and must be administered
frequently and in high doses, limiting its utility due to toxicity
and convenience of use.
About Nektar Therapeutics
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
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: "promising," "potential," "design," "provide," "may," "will"
and similar references to future periods. Examples of
forward-looking statements include, among others, statements we
make regarding the expected benefits of NKTR-255 (both alone as a
single agent as well as in combination with other agents, such as
multiple targeted antibodies), the ability to obtain useful data
from the Phase 1 clinical study of NKTR-255, and the future
clinical development plans for NKTR-255. 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) NKTR-255 is in early-stage
clinical development and there are substantial risks that can
unexpectedly occur for numerous reasons including negative safety
and efficacy findings in the Phase 1 clinical study notwithstanding
positive preclinical findings; (ii) clinical study outcomes,
including the Phase 1 clinical study outcome of NKTR-255, remain
very unpredictable and it is possible that a clinical study could
fail due to efficacy, safety or other important clinical findings;
(iii) the timing of the commencement or end of clinical trials 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, and competitive factors; (iv) scientific discovery of new
therapeutics is an inherently uncertain process and the future
success of applying our technology platform to potential new drug
candidates (such as NKTR-255) is therefore highly uncertain and
unpredictable; (v) patents may not issue from our patent
applications for NKTR-255, 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 Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission on
August 9, 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:
Vivian Wu of Nektar Therapeutics
628-895-0661
For Media:
Jodi Sievers
of Nektar Therapeutics
415-482-5593
Dan Budwick of 1AB
973-271-6085
dan@1abmedia.com
1. Messaoudene M., et al., (2017) Patient's Natural Killer
Cells in the Era of Targeted Therapies: Role for Tumor Killers.
Front. Immunol. 8:683.
2. Farnault, L., et al., Hematological Malignancies Escape
from NK Cell Innate Immune Surveillance: Mechanisms and Therapeutic
Implications. Clinical and Developmental Immunology Volume
2012, Article ID 421702, 8 pages
3. Journal for ImmunoTherapy of Cancer 2017 5(Suppl 2):87;
P332.
4. Miyazaki T., et al., 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. In: Proceedings of the Annual Meeting of the
AACR; 2019. Abstract 3265.
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