SAN FRANCISCO, Feb. 17, 2021 /PRNewswire/ -- Nektar Therapeutics
(Nasdaq: NKTR), a clinical-stage biopharmaceutical company focused
on the development and commercialization of novel therapies for
cancer and auto-immune disease, today announced a financing and
co-development collaboration with SFJ Pharmaceuticals to
support the development of Bempegaldesleukin (BEMPEG), an
investigational CD122-preferential IL-2–pathway agonist. SFJ
Pharmaceuticals is a global drug development company backed by
Abingworth and Blackstone Life Sciences.
The collaboration between SFJ and Nektar will support a new
Phase 2/3 registrational clinical study of BEMPEG plus
pembrolizumab in patients with head and neck cancer whose tumors
express PD-L1 (Combined Positive Score [CPS] ≥1). Under the terms
of the agreement, SFJ has agreed to fund up to $150
million to support the study and manage clinical trial
operations. Nektar will serve as the sponsor of the Phase 2/3
study.
"This innovative collaboration with SFJ provides Nektar with
substantial non-dilutive funding to broaden the registrational
program for BEMPEG," said Howard Robin, President and CEO of
Nektar Therapeutics. "SFJ's global drug development and clinical
trial management expertise, coupled with a track record of success
in accelerating and advancing late-stage development programs for
global pharmaceutical companies, make them an ideal partner."
Under the terms of the new agreement, SFJ will fund up to
$150 million for the Phase 2/3 study
until its completion. In return, Nektar agrees to pay SFJ
success-based annual milestone payments over a period of seven to
eight years, which are contingent upon receipt of certain U.S.
regulatory approvals for specified indications for BEMPEG and will
begin following completion of the head and neck study that is
projected to be in 2024. If BEMPEG does not receive regulatory
approval for one or more of the specified indications, Nektar will
not owe any future payments linked to an indication that is not
approved.
"We are excited to be partnering with Nektar under this novel
financing and co-development agreement," said Bob DeBenedetto,
Chief Executive Officer of SFJ. "Based on the strength of the
clinical data generated to date for BEMPEG in melanoma and other
tumor types, and following an extensive diligence process conducted
in conjunction with our partners at Blackstone Life Sciences and
Abingworth, we believe that BEMPEG has great potential to help
cancer patients. We look forward to supporting the Phase 3 study
and working closely with the Nektar team."
Morgan Stanley & Co. LLC acted as the sole structuring agent
to Nektar on the transaction.
About Bempegaldesleukin (BEMPEG; NKTR-214)
Bempegaldesleukin (BEMPEG: NKTR-214) is an investigational
CD122-preferential IL-2–pathway agonist that leverages the
clinically validated IL-2 pathway to stimulate an antitumor immune
response.1 BEMPEG was engineered to deliver a
controlled, sustained, and preferential IL-2 pathway signal, with
the goals of stimulating an antitumor immune response while
minimizing toxicity, thereby allowing for outpatient
administration.1,2 In a phase 1 trial of BEMPEG in
combination with the checkpoint inhibitor nivolumab (NIVO;
PIVOT-02), the combination was well tolerated and produced durable
responses that deepened over time in multiple advanced solid tumor
types.3
In February of 2018, Nektar and
Bristol-Myers Squibb entered into a global strategic
development and commercialization collaboration for BEMPEG. Under
the terms of the agreement, Nektar is eligible to receive
$1.45 billion in regulatory filing
and approval milestones for BEMPEG. Nektar will book revenue for
worldwide sales of BEMPEG and the companies will split
global profits for BEMPEG with Nektar receiving 65% and
Bristol-Myers Squibb 35%. The agreement allows Nektar to develop
BEMPEG with other checkpoint inhibitor therapies in tumor types
outside of the Nektar-Bristol-Myers Squibb joint clinical
development program for BEMPEG plus NIVO.
In July of 2019, Bristol-Myers
Squibb and Nektar announced that the U.S. Food
and Drug Administration granted Breakthrough Therapy
Designation for investigational agent bempegaldesleukin in
combination with nivolumab for the treatment of patients
with previously untreated unresectable or metastatic melanoma.
The joint clinical development program for BEMPEG plus NIVO
includes registrational and other studies of BEMPEG plus NIVO in
melanoma, renal cell carcinoma or RCC, and bladder cancer. This
includes a Phase 3 trial in first-line advanced melanoma
(NCT03635983), a Phase 3 trial in adjuvant melanoma (NCT04410445),
a Phase 3 trial in advanced RCC (NCT03729245), a Phase 3 trial
in muscle-invasive bladder cancer (NCT04209114), a Phase 2 trial in
cisplatin-ineligible urothelial carcinoma (NCT03785925), a Phase
1/2 trial in combination with a tyrosine kinase inhibitor in
advanced RCC (NCT04540705) and a Phase 1/2 trial in children,
adolescents and young adults with recurrent or treatment-resistant
cancer (NCT04730349).
BEMPEG is also being evaluated separately in the PROPEL study in
combination with pembrolizumab in patients with first-line
metastatic non-small cell lung cancer (NCT03138889) and in
collaboration with Vaccibody in the DIRECT-01 study in combination
with VB10.NEO in squamous cell carcinoma of the head and neck
(NCT03548467).
About Head and Neck Cancer
Squamous cell carcinoma of the head and neck, which forms in the
tissues of the moist, mucosal surfaces inside the mouth, nose and
throat, is the sixth most common cancer worldwide. In 2020, there
were more than 850,000 cases leading to 440,000 deaths, according
to The Global Cancer Observatory. The incidence of SCCHN continues
to rise and is expected to increase by about 40% by 2040. According
to data from the SEER registry, 5-year survival rate was estimated
to be 66% for patients diagnosed with SCCHN and 40% for
patients with metastatic disease, during the period 2010-2016.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly owned R&D pipeline of investigational medicines
in oncology, immunology and virology. 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.
About the SFJ Pharmaceuticals Group
SFJ is a global drug development company, which provides a
unique and highly customized co-development partnering model for
the world's top pharmaceutical and biotechnology companies. SFJ
provides at-risk funding and the global clinical development
management and oversight necessary for regulatory submission for
some of the most promising drug development programs of
Pharmaceutical and Biotechnology companies. SFJ's mission is to
leverage its financial strength and global team of pharmaceutical
development experts to accelerate the development of life-saving
and life-enhancing drugs for the benefit of physicians and the
patients they serve.
- Bentebibel S-E, et al. A First-in-Human Study and Biomarker
Analysis of NKTR-214, a Novel IL2Rβγ -Biased Cytokine, in
Patients with Advanced or Metastatic Solid Tumors. Cancer
Discovery 2019;9:711-21.
- Charych D, et al. Modeling the receptor pharmacology,
pharmacokinetics, and pharmacodynamics of NKTR-214, a kinetically
controlled interleukin-2 (IL2) receptor agonist for cancer
immunotherapy. PLoS ONE 2017;12.
- Diab A, et al. Bempegaldesleukin (NKTR-214) plus nivolumab in
patients with advanced solid tumors: Phase 1 dose-escalation study
of safety, efficacy and immune activation
(PIVOT-02). Cancer Discovery 2020
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can
be identified by words such as: "will," "develop," "may,"
"provide," "deliver" and similar references to future periods.
Examples of forward-looking statements include, among others,
statements we make regarding the therapeutic potential of
bempegaldesleukin (BEMPEG) in combination with other agents (such
as nivolumab and pembrolizumab), the availability of results from
clinical studies, and the potential benefits of co-development
collaborations. 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 are based on preclinical and
clinical findings and the expected therapeutic potential for
bempegaldesleukin is subject to change as research and development
continue; (ii) bempegaldesleukin is in clinical development and the
risk of failure remains high and failure can unexpectedly occur at
any stage for one or more of the indications being studied prior to
regulatory approval due to lack of sufficient efficacy, safety
considerations or other factors that impact drug development; (iii)
data reported from ongoing preclinical and clinical trials are
necessarily interim data only and the final results will change
based on continuing observations; (iv) scientific discovery of new
medical breakthroughs is an inherently uncertain process and the
future success of potential new drug candidates (such as
bempegaldesleukin) is therefore very uncertain and unpredictable;
(v) the timing of the commencement or end of clinical studies 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, delays caused by our collaboration partners and the
COVID-19 pandemic, and enrollment competition; (vi) projected costs
for completing clinical trials are estimates only and the actual
costs will vary and can be higher depending on a number of factors,
such as unexpected changes in healthcare costs over time, the need
to increase the number of clinical trial sites, and the length of
time the trial is conducted; (vii) 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 (viii) 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:
Vivian
Wu of Nektar Therapeutics
628-895-0661
For Media:
Dan Budwick of 1AB
dan@1abmedia.com
973-271-6085
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