SAN FRANCISCO, Oct. 27, 2020 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ: NKTR) today announced that it has received
FDA clearance for an Investigational New Drug (IND) application for
its investigational IL-2 pathway agent, bempegaldesleukin (BEMPEG,
NKTR-214), to be evaluated in a Phase 1b clinical study in adult patients who have been
diagnosed with mild COVID-19 infection. The study is designed to
evaluate whether BEMPEG's ability to stimulate lymphocyte
production could improve treatment regimens for COVID-19
patients. Enrollment in the Phase 1b, randomized, double-blind, placebo-controlled
study is planned to start in early November.
The company will hold an analyst and investor conference call
this morning, Tuesday, October 27,
2020, at 8:30 a.m. Eastern Daylight
Time (EDT). The call will include Nektar COVID-19 Study
Steering Committee Co-Chairs: Dr. Richard
Bucala MD, PhD, Waldemar Von Zedtwitz Professor of Medicine,
Pathology, and Epidemiology and Chief of Rheumatology, Allergy
& Immunology at the Yale School of
Medicine and Dr. Robert
Gallo, co-founder and director of the Institute of Human
Virology at the University of Maryland School
of Medicine.
BEMPEG is an investigational CD122-preferential IL-2 pathway
agonist that stimulates the immune system through the proliferation
of lymphocytes. It is currently being evaluated in six separate
late-stage clinical studies in patients diagnosed with melanoma,
renal cell carcinoma and bladder cancer.
"Decreased levels of lymphocytes have been associated with
increased mortality in hospitalized COVID-19 patients. Providing
these patients with an agent like BEMPEG that can drive anti-viral
adaptive immunity has the potential to improve these outcomes,"
said Dr. Bucala. "We believe this development program is important
to determine whether stimulating the adaptive immune response with
BEMPEG improves patient outcomes, and to hopefully bring this
treatment to patients afflicted with COVID-19."
The Phase 1b, randomized,
double-blind, placebo-controlled study is designed to assess the
safety, tolerability, and pharmacokinetic/pharmacodynamic profile
of BEMPEG in adult patients with mild COVID-19. Eligibility
criteria include symptoms such as fever, cough, sore throat,
malaise, headache, and muscle pain without evidence of severe
dyspnea or acute respiratory distress syndrome. Patients who
meet the eligibility criteria will be randomized and treated with
either a single dose of BEMPEG or placebo in combination with
current standard of care treatment for patients with mild COVID-19.
Primary and secondary endpoints include change over time in
absolute lymphocyte counts and measurements of clinical progression
based upon the WHO Clinical Progression Scale. The trial will
enroll up to three cohorts of ten patients each, who will receive
increasing doses of BEMPEG with the aim of evaluating safety and
tolerability and to identify the recommended dose for future
studies. The clinical trial will be conducted at various
investigator sites in the United
States.
"After many months of evaluating the emerging body of data on
the correlation of decreased lymphocyte levels and the severity of
disease in patients with COVID-19, Nektar and our scientific and
clinical advisors made the decision to proceed with this important
study of our cytokine investigational therapy BEMPEG," said Dr.
Jonathan Zalevsky, Ph.D., Chief
Research & Development Officer at Nektar. "Recovery in
hospitalized COVID-19 patients has been linked to a robust T cell
response, and our objective with the introduction of BEMPEG
investigational therapy is to help the patient mount a
comprehensive cellular and humoral immune response to the virus.
The study design allows us to evaluate whether early intervention
with BEMPEG's adaptive immune-stimulating mechanism that promotes
priming and proliferation of T cells and NK cells could be useful
in the emerging treatment armamentarium for COVID-19. Following the
successful completion of this initial Phase 1b study, our plan is to advance development into
COVID-19 patients who present with lymphopenia. We are
hopeful that this unique approach could ultimately lead to a
reduction in the severity of disease and in long-term
hospitalizations and mortality."
Analyst Call Details
Date and Time: Tuesday, October
27, 2020 at 8:30 a.m. Eastern
Daylight Time
Dial-in: (877) 881-2183 (toll-free) or (970) 315-0453
(Conference ID: 1418007)
Investors and analysts can also view slides and listen to the live
audio webcast of the presentation at
https://edge.media-server.com/mmc/p/tc46muyj. The event will also
be available for replay for two weeks on the company's website,
www.nektar.com.
Dr. Richard Bucala
Richard Bucala, MD, PhD, is a
Professor of Medicine, Pathology, and Epidemiology & Public
Health at the Yale School of Medicine.
He studies the mechanisms by which protective immune responses lead
to immunopathology, focusing on MIF-family cytokines and their
genetics, which his group first cloned and characterized.
Currently, his laboratory is leading multidisciplinary efforts to
develop immunotherapies tailored to an individual's genetic makeup.
An anti-MIF antibody developed by his group is undergoing clinical
evaluation in oncology and additional MIF antagonists are in
advanced clinical testing for different inflammatory indications.
Dr. Bucala also is credited with the discovery of the fibrocyte,
which is being targeted therapeutically in different fibrosing
disorders. He is a co-founder of MIFCOR, a biotechnology startup
begun as a student-advised project. Dr. Bucala was elected to the
American Society for Clinical Investigation and the Association of
American Physicians. He is the former Editor-in-Chief of
Arthritis & Rheumatology and has served on numerous
advisory boards for the NIH, the pharmaceutical industry, academia,
and private foundations.
Dr. Robert Gallo
Robert C. Gallo, MD is the
co-founder of The Institute of Human Virology (IHV) at the
University of Maryland School of
Medicine. He led the team that discovered IL-2 and
identified the first retroviruses in humans. He became world famous
in 1984 when he co-discovered HIV as the cause of AIDS, and his
team developed the first blood test for HIV. Little was known then
of the mysterious disease that was fast becoming the deadliest in
medical history. Since then, Dr. Gallo has spent much of his career
trying to put an end to this raging epidemic and other viral,
chronic illnesses. Lifetime achievements in Dr. Gallo's legendary
career include discoveries that have led to both diagnostic and
therapeutic advances in cancer, AIDS and other viral disorders
while his vision remains unprecedented in the field of
virology.
About Bempegaldesleukin (BEMPEG; NKTR-214)
BEMPEG is an investigational, first-in-class, CD122-preferential
IL-2 pathway agonist designed to provide rapid activation and
proliferation of cytotoxic immune cells, known as CD8+
effector T cells and natural killer (NK) cells, without over
activating the immune system. The agent is designed to stimulate
these immune cells in the body by targeting CD122 specific
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 BEMPEG 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 being
used to treat a range of cancers.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly owned R&D pipeline of investigational medicines
in oncology and immunology 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: "may," "design," "potential,"
"evaluate," "plan," "will," and similar references to future
periods. Examples of forward-looking statements include, among
others, statements we make regarding the therapeutic potential of,
and future development plans for, bempegaldesleukin, and the timing
of the initiation of clinical studies for bempegaldesleukin.
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 bempegaldesleukin in patients who have been diagnosed
with COVID-19 infection are based on data that is evolving and does
not include clinical testing of bempegaldesleukin for this intended
patient population, and there is no guarantee that the clinical
evaluation of bempegaldesleukin in COVID-19 patients will support
the use of bempegaldesleukin in this patient population; (ii)
bempegaldesleukin is an investigational agent and continued
research and development for this drug candidate 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) as
bempegaldesleukin is currently in clinical development, the risk of
failure is high and failure 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 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) 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 our Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on
August 7, 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.
1. Boyman, J., et al., Nature Reviews Immunology, 2012,
12:180-90.
2. Charych, D., et al., Clin Can
Res, 2016, 22(3):680-90.
3. Diab, A., et al., Journal for ImmunoTherapy of Cancer,
2016, 4(Suppl 1):P369
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
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SOURCE Nektar Therapeutics