SAN
FRANCISCO, Sept. 27, 2023 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) announced today that it has entered
into a new clinical study collaboration with Cellular Biomedicine
Group Inc. ("CBMG"). The study will evaluate Nektar's
NKTR-255, a novel interleukin-15 (IL-15) receptor agonist, in
combination with CBMG's C-TIL051, a tumor-infiltrating lymphocyte
(TIL) therapy, in advanced non-small cell lung cancer (NSCLC)
patients that are relapsed or refractory to anti-PD-1 therapy.
NKTR-255 is a novel polymer-conjugated human IL-15 receptor
agonist currently being studied in two separate Phase 2 studies in
combination with cell therapies and immunotherapies. Preclinical
and early clinical data suggest that IL-15 can improve
proliferation and persistence of cellular therapies including TIL,
TCR, and CAR-T therapies to increase specific anti-tumor
activity.
"Early results have shown that NKTR-255 has the potential to
emerge as a valuable adjuvant therapy for a range of cell therapy
platforms," said Mary Tagliaferri,
M.D., Chief Medical Officer at Nektar Therapeutics. "We are excited
to partner with CBMG, a leader in the development of the next
generation of cell therapies, to evaluate this novel combination in
the clinical setting of lung cancer. Combining NKTR-255 and
C-TIL051 could have the potential to deliver deep and durable
objective responses with a well-tolerated regimen to patients
battling relapsed or refractory NSCLC."
C-TIL051 is an autologous adoptive cell therapy being developed
by CBMG that is comprised of a patient's ex vivo expanded
lymphocytes using CBMG's proprietary manufacturing process. The
development of C-TIL051 was based on initial NSCLC TIL studies
demonstrating encouraging safety and efficacy results (NCT03215810,
NCT03645928). In October of last year, CBMG received clearance of
an Investigational New Drug (IND) application for C-TIL051 for
late-stage NSCLC patients that are relapsed or refractory to
anti-PD-1 therapy.
Under the new collaboration, CBMG will add NKTR-255 to its
ongoing CBMG-sponsored Phase 1 clinical trial evaluating C-TIL051
in NSCLC patients who have relapsed on or were refractory to
anti-PD-1 therapy, which is being conducted at Duke Cancer
Institute (NCT05676749). The study is expected to enroll a total of
20 patients. Nektar will contribute NKTR-255 supply for the study.
Nektar and CBMG will each maintain existing global rights to their
respective investigational medicines.
About NKTR-255
NKTR-255 is a biologic that targets the IL-15 pathway in order
to activate the body's innate and adaptive immunity. Through
optimal engagement of the IL-15 receptor complex, NKTR-255 is
designed to enhance functional NK cell populations and formation of
long-term immunological memory, which may lead to sustained and
durable anti-tumor immune response.
Preclinical and early clinical findings suggest IL-15 can
improve proliferation and persistence of cellular therapies
including TIL, TCR, and CAR-T therapies to increase specific
anti-tumor activity.
NKTR-255 is currently being studied in two separate Phase 2
studies in combination with cell therapies and immunotherapy. A
Phase 2/3 study is underway that combines NKTR-255 with approved
CAR-T cell therapies in patients with diffuse large B-cell
lymphoma, which is currently recruiting (NCT05664217). NKTR-255 is
also being studied in a Phase 2 study in combination with avelumab
as a maintenance treatment in patients with locally advanced or
metastatic urothelial carcinoma in the Merck KGaA-sponsored JAVELIN
Bladder Medley trial (NCT05327530), as well as in combination with
durvalumab in patients with locally advanced NSCLC in an IST
conducted at M.D. Anderson Cancer Center.
In addition, there are two ongoing investigator sponsored trials
(ISTs) evaluating NKTR-255 as adjunct therapy following a CAR-T
cell therapy. Fred Hutchinson Cancer Center is conducting a Phase 1
study evaluating NKTR-255 following lisocabtagene maraleucel
treatment in patients with relapsed/refractory large B-cell
lymphoma (NCT05359211), and Stanford
University is conducting a Phase 1 study evaluating NKTR-255
following an investigational CD19/22 CAR-T cell therapy in patients
with relapsed or refractory B-cell acute lymphoblastic leukemia
(NCT03233854).
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly owned R&D pipeline of investigational medicines
in immunology and oncology as well as a portfolio of approved
partnered medicines. Nektar is headquartered in San Francisco, California, with additional
manufacturing operations in Huntsville,
Alabama. 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: "will," "may," "evaluate,"
"develop," "provide," "potential" and similar references to future
periods. Examples of forward-looking statements include, among
others, statements regarding the therapeutic potential of, and
future development plans for NKTR-255, and our other drug
candidates in research programs, the prospects and plans for our
collaborations with other companies, the timing of the initiation
of clinical studies and the data readouts for our drug candidates.
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-255, and our other drug candidates are based on
preclinical and clinical findings and observations and are subject
to change as research and development continue; (ii) NKTR-255 and
our other drug candidates are investigational agents and continued
research and development for these drug candidates is subject to
substantial risks, including negative safety and efficacy findings
in ongoing clinical studies (notwithstanding positive findings in
earlier preclinical and clinical studies); (iii) NKTR-255 and our
other drug candidates are in various stages of clinical development
and the risk of failure is high and can unexpectedly occur at any
stage prior to regulatory approval; (iv) the timing of the
commencement or end of clinical trials and the availability of
clinical data may be delayed or unsuccessful due to challenges
caused by the COVID-19 pandemic, 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; (v) we may not achieve the expected cost savings
we expect from our 2022 corporate restructuring and reorganization
plan or our 2023 cost restructuring plan and we may undertake
additional restructuring and cost-saving activities in the future,
(vi) 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 (vii) certain other important risks and
uncertainties set forth in our Annual Report on Form 10-Q filed
with the Securities and Exchange Commission on August 9, 2023. 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:
David Rosen
of Argot Partners
212-600-1902
david.rosen@argotpartners.com
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