OSLO, Norway and SAN FRANCISCO, April 1,
2019 /PRNewswire/ -- Vaccibody AS and Nektar Therapeutics
(Nasdaq: NKTR) today announced the presentation of new preclinical
data for VB10.NEO, a personalized neoantigen cancer vaccine,
combined with bempegaldesleukin (NKTR-214 or bempeg), a
CD122-preferential IL-2 pathway agonist. These data were presented
today in a poster session at the American Association for Cancer
Research (AACR) Annual Meeting 2019.
"We are excited to present these novel preclinical data that
show combining bempeg with VB10.NEO synergize to increase both the
breadth and the depth of the neoantigen-specific immune response.
These unique and non-overlapping mechanisms produced an expansion
of the VB10.NEO elicited neoantigen-specific T cells and
demonstrated enhanced anti-tumor efficacy in mice. We look forward
to evaluating this novel immuno-oncology combination in a clinical
study in patients with advanced or metastatic squamous cell
carcinoma of head and neck later this year," said Agnete B. Fredriksen, Ph.D., Vaccibody's
President and Chief Scientific Officer.
VB10.NEO is designed to specifically activate a patient's immune
system to tumor-specific antigens, called neoantigens. Bempeg is
designed to expand and proliferate tumor antigen-specific T cells
in the tumor microenvironment. Addition of bempeg to VB10.NEO is
intended to drive maximal expansion of vaccine-induced
neoantigen-specific T cells for the treatment of cancer.
"Personalized T cell vaccines could play a critical and central
role in cancer immunotherapy," said Jonathan Zalevsky, Ph.D., Chief Scientific
Officer at Nektar. "These preclinical data highlight the potential
of combining a personalized cancer vaccine with a T cell
proliferator to induce maximal expansion of vaccine-induced T cell
clones and durable responses and specific anti-tumor immunity. We
are highly encouraged by these results and look forward to testing
this unique approach to personalized cancer treatment in patients
with squamous cell carcinoma of the head and neck."
Details of the poster presentation at AACR are as follows and
will be available for download at the time of presentation at
http://www.vaccibody.com/scientific-presentations/ and
https://www.nektar.com/download_file/662/0.
Abstract #2256
Title: "Combination of neoantigen DNA plasmid
vaccine VB10.NEO and NKTR-214, a CD122-biased immunostimulatory
cytokine, induces strong neoantigen-specific T cell responses and
sustained tumor regression in pre-clinical models"
Session: Clinical Research – Combination Therapies 1
Session Data and Time: Monday, April 1,
2019, 1:00 p.m. - 5:00 p.m. Eastern
Time
- Combination of VB10.NEO and NKTR-214 synergizes to elicit
greater breadth and depth of neoantigen-specific T cell responses
than each individual treatment.
- The synergistic effect was observed in both CD4 and CD8 T
cells, and most pronounced on CD8 T cell responses, further
supporting the combination's potential to induce strong immunogenic
CD8+ T cell responses.
- VB10.NEO in combination with NKTR-214 and anti-PD-1 induce
rapid, complete and durable tumor regression of small tumors and
long-lasting stabilization of large tumors supporting the rationale
for examining the combination clinically.
In September 2018, Nektar and
Vaccibody entered into a clinical collaboration to evaluate
bempegaldesleukin in combination with VB10.NEO. A pilot study
evaluating the combination in patients with squamous cell carcinoma
of the head and neck is planned to begin mid-2019.
About VB10.NEO
VB10.NEO, is a proprietary therapeutic DNA vaccine which uses the
patient's own neoantigens for the personalized treatment of cancer
patients. A phase I/IIa neoantigen clinical trial is currently
enrolling patients with locally advanced or metastatic melanoma,
non-small cell lung carcinoma, clear renal cell carcinoma as well
as urothelial cancer or squamous cell carcinoma of the head and
neck.
About bempegaldesleukin (NKTR-214)
Bempegaldesleukin
is an investigational, first-in-class, CD122-preferential IL-2
pathway agonist designed to provide rapid activation and
proliferation of cancer-killing immune cells, known as CD8+
effector T cells and natural killer (NK) cells, without over
activating the immune system. Bempegaldesleukin stimulates these
cancer-killing immune cells in the body by targeting CD122
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 bempegaldesleukin 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.
About Vaccibody
Vaccibody is a clinical-stage biopharmaceutical company dedicated
to the discovery and development of novel immunotherapies. The
company is a leader in the rapidly developing field of
individualized cancer neoantigen vaccines and is using the
Vaccibody technology to generate best-in-class therapeutics to
treat cancers with a high unmet medical need. A phase I/IIa
neoantigen clinical trial is currently enrolling patients with
locally advanced or metastatic melanoma, non-small cell lung
carcinoma, clear renal cell carcinoma as well as urothelial or
squamous cell carcinoma of the head and neck. Vaccibody's most
advanced program (VB10.16) is a therapeutic DNA vaccine against
HPV16 induced pre-malignancies and malignancies. The first-in-human
study (phase I/IIa), which has reported positive 12M data demonstrating a well-tolerated safety
profile, strong immunogenicity and clinical efficacy of
VB10.16 in women with high grade cervical intraepithelial neoplasia
(HSIL; CIN 2/3). Further information about the company and its drug
development programs and capabilities may be found online at
http://www.vaccibody.com.
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 our 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
Nektar and its drug development programs and capabilities may be
found online at http://www.nektar.com.
Nektar Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which
can be identified by words such as: "will," "intend," "may,"
"planned," "believe," "designed," and similar references to future
periods. Examples of forward-looking statements include, among
others, statements we make regarding the therapeutic potential of
bempegaldesleukin in combination with VB10.NEO, the future
development plans bempegaldesleukin in combination with VB10.NEO,
and the availability of results and outcomes from our clinical and
preclinical studies. 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 in combination with
VB10.NEO are based on preclinical findings studies and future data
generated from new studies may be materially different; (ii)
bempegaldesleukin and VB10.NEO are in early stage clinical
development and the risk of failure remains high and failure can
unexpectedly occur at any stage for one or more of the cancer
indications being studied prior to regulatory approval due to lack
of sufficient efficacy, safety considerations or other factors that
negatively impact drug development; (iii) the timing of the
commencement and end of clinical studies and the availability of
clinical data may be delayed due to regulatory delays, slower than
anticipated patient enrollment, manufacturing challenges, changing
standards of care, evolving regulatory requirements, clinical trial
design, or clinical outcomes; (iv) scientific discovery of new
medical breakthroughs is an inherently uncertain process and the
future regulatory approval of potential new drug candidates (such
as bempegaldesleukin and VB10.NEO) is therefore very uncertain and
unpredictable; (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 Nektar's Annual
Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and
Exchange Commission on March 1, 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.
Vaccibody Contact:
CEO Martin Bonde, PhD
Vaccibody AS
Cell: +45 2025 3560
mbonde@vaccibody.com
Nektar Contacts:
For Investors:
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
or
Ashleigh Barreto of Nektar
Therapeutics
628-895-0694
For Media:
Dan Budwick of 1AB
973-271-6085
dan@1abmedia.com
1 Boyman, J., et al., Nature Reviews Immunology, 2012, 12,
180-190.
2 Charych, D., et al., Clin Can Res;
22(3) February 1, 2016
3 Diab, A., et al., Journal for ImmunoTherapy of Cancer 2016,
4(Suppl 1): P369
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