SAN FRANCISCO, Dec. 15, 2020 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ:NKTR) today announced that the first patient
has been dosed in the Phase 1/2 trial of NKTR-255, Nektar's
investigational IL-15 pathway agonist, in patients with relapsed or
refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or
colorectal cancer (CRC) at the START Center for Cancer Care in
San Antonio, TX. The study is
evaluating NKTR-255 plus cetuximab in up to 80 patients at
approximately 15 investigator sites in the United States and European Union.
NKTR-255 is designed to activate the IL-15 pathway and expand
Natural Killer (NK) cells as well as promote the survival and
expansion of CD8+ T cells without inducing suppressive regulatory T
cells. Cetuximab is a monoclonal antibody against epidermal growth
factor receptor (EGFR) and is approved for the treatment of
advanced HNSCC and CRC.
"An NK-cell agent such as NKTR-255 is a perfect and unique
complement to monoclonal antibody therapies which induce
antibody-dependent cellular cytotoxicity," said Wei Lin, MD, Head of Development at Nektar. "Our
body of preclinical and clinical data for NKTR-255 demonstrates
that this novel agent not only induces NK cell proliferation but
also enhances their cytotoxic immune effector function. With this
new Phase 1/2 study in HNSCC and CRC, we are excited to expand our
NKTR-255 development program beyond the hematological setting into
solid tumors."
Nektar recently presented the first clinical data for NKTR-255
at the most recent 2020 Society for Immunotherapy in Cancer (SITC)
Annual Meeting in November. The data demonstrated that NKTR-255 was
well tolerated and biologically active, and treatment resulted in
consistent expansion of lymphocytes, with durable and sustained
increases in NK and CD8+ T cells in a highly refractory population
of patients with multiple myeloma (MM) and non-Hodgkin lymphoma
(NHL).
The new Phase 1b/2 study will test
the combination of NKTR-255 with cetuximab in two groups of
patients. One group will consist of R/R head and neck cancer
patients who have progressed after treatment with platinum-based
chemotherapy and a checkpoint inhibitor. The second group will
include patients with metastatic colorectal cancer who have
received two prior treatments for metastatic disease. The trial
will begin with a dose-finding portion for the combination, which
will then be expanded into dedicated cohorts for head and neck and
colorectal cancer patients.
About NKTR-255
NKTR-255 is an investigational 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 functional NK
cell population and 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
and other IL-15 agonists, which are rapidly cleared from the body
and have shown diminishing response to successive
doses.1 NKTR-255 is wholly-owned by Nektar.
About Nektar
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly owned R&D pipeline of investigational medicines
in oncology, immunology, and virology as well as a portfolio of
approved partnered medicines. 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: "potential," "design," "enhance,"
"may," "test," "evaluate" 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 cetuximab), the ability to obtain useful data from
the Phase 1b/2 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 1b/2 clinical study
notwithstanding positive preclinical findings; (ii) clinical study
outcomes, including the Phase 1b/2
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 November 6, 2020. 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:
Jerry
Isaacson of Nektar Therapeutics
628-895-0634
Vivian Wu of Nektar Therapeutics
628-895-0661
For Media:
Dan Budwick
of 1AB
973-271-6085
dan@1abmedia.com
1. Blood 2018 Jun
7;131(23):2515-2527
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SOURCE Nektar Therapeutics