- World’s first combination of off-the-shelf NK with checkpoint
inhibitor plus antigen simulation via adenovirus to induce immune
system activation
- Ongoing durable complete responses ranging from 8 to 11 months
observed in TNBC patients who failed standard of care
- Disease control rate of 78% and overall response rate of 67% in
heavily pretreated patients
- Median progression free survival exceeds 13 months compared to
historical controls of 2-3 months in advanced third-line
setting
- Ongoing survival to date of 78% of patients ranging from 2 to
12 months
NantKwest Inc. (Nasdaq: NK), a clinical-stage natural killer
cell-based therapeutics company, and ImmunityBio, a privately held
immunotherapy company, today announced results from their Phase 1b
trial investigating a novel, first-in-human immunotherapy protocol
consisting of NantKwest’s off-the-shelf, antibody-targeted NK cells
(haNK) combined with ImmunityBio’s IL-15 superagonist (N-803),
low-dose metronomic chemoradiation therapy, adenoviral and yeast
tumor-associated antigen vaccines (MUC1, brachyury, CEA) and a
PD-L1 checkpoint inhibitor in patients with metastatic triple
negative breast cancer (TNBC) who had relapsed after prior
therapy.
The results were presented at the 2019 San Antonio Breast Cancer
Symposium (SABCS) on December 13, 2019, in San Antonio, Texas, in a
poster titled “Safety and efficacy from first-in-human
immunotherapy combining NK and T-cell activation with
off-the-shelf, antibody-targeted CD16 NK cell line (haNK) in
patients with 2nd-line or greater metastatic triple-negative breast
cancer (TNBC).”
This landmark study is the world’s first trial to combine
cellular therapy with checkpoint inhibitors and IL-15 cytokine
stimulation, as well as with adenoviral vectors, all acting in
concert to induce immune simulation of both NK cells and T
cells.
“We are extremely pleased that the FDA granted us IND
authorization to initiate this novel immunotherapy trial enabling
the safety and efficacy study of multiple novel biological agents
administered as a single protocol in the outpatient setting,” said
Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. “This
important trial forms the basis of our approach to induce
immunogenic cell death and long-term memory, and avoid the ravages
of high dose chemotherapy.”
“Achieving durable, complete responses in metastatic TNBC
patients that have failed all current standards of care is a
promising finding and further validates our approach to orchestrate
both the innate and adaptive immune system,” continued Soon-Shiong.
“TNBC is a highly aggressive cancer, with limited treatment options
and poor prognosis. These results are important proof-of-concept
supporting our hypothesis that comprehensively activating the
immune responses of the NK, T and Dendritic cells would induce
immunogenic cell death leading to durable responses, even among
this challenging patient population. We are thrilled with the
safety and efficacy data from this first-in-human clinical trial of
combination NK cell therapy, cytokine fusion protein,
chemoradiation and checkpoint inhibitor, and look forward to
advancing this exciting off-the-shelf cell therapy approach to
randomized clinical trials in this setting.”
Data Highlights Include:
- Of 9 patients treated, efficacy results include a disease
control rate of 78% (7/9 patients) and an overall response rate of
67% (6/9 patients).
- 2 out of 9 patients to date have ongoing complete responses
with durations ranging from 8 to 11 months, with a 3rd patient
demonstrating a partial response (near complete response) in the
target lesion after initiation of targeted and endocrine therapy
off-study.
- To date, 7 patients are alive with durations of response
ranging from 2 to 12 months with 4 patients remaining on study.
Median progression-free survival rate is 13.7 months.
- All patients were treated in an outpatient setting with
treatment generally safe and well tolerated and no observed
cytokine release syndrome.
- No immune related SAEs were attributed to the immunotherapy
investigational agents
- All patients had at least 1 grade ≥ 3 TRAE, primarily
chemotherapy-related neutropenia or anemia. Grade ≥ 3 haNK-related
AEs, namely fever and fatigue, were observed in 2 patients.
- Early data from peripheral blood analysis demonstrate clonal
selection occurs with the immunotherapy regimen enabling targeted
therapy tailored to patient specific mutations identified via next
generation sequencing.
“The approximately 10-20% of breast cancer patients who are
triple negative are faced with a grim prognosis with limited
treatment options. These results are clinically significant, with
overall response rates and complete response rates in this highly
refractory, advanced metastatic patient population,” said Dr.
Chaitali Nangia, a Hematologist/Oncologist with the Chan
Soon-Shiong Immuno-Oncology Network and study co-author.
“Importantly, these responses to treatment are also durable, with
median progression free survival exceeding 13 months compared to
historical controls of approximately 3 months in this heavily
pretreated population. We also observed a positive safety and
tolerability profile, with no cytokine release syndrome. Taken
together, these efficacy and safety results point to the emergence
of a new treatment paradigm for TNBC.”
About NantKwest
NantKwest (NASDAQ: NK) is an innovative, clinical-stage
immunotherapy company focused on harnessing the power of the innate
immune system to treat cancer and virally induced infectious
diseases. We are the leading producer of clinical dose forms of
off-the-shelf Natural Killer (NK) cell therapies. Our activated NK
cell platform is designed to destroy cancer and virally infected
cells from the body. The safety of our optimized, activated NK
cells, as well as their activity against a broad range of cancers,
have been tested in phase I clinical trials in Canada and Europe,
as well as in multiple phase I and II clinical trials in the United
States. By leveraging an integrated and extensive genomics and
transcriptomics discovery and development engine, together with a
pipeline of multiple, clinical-stage, immuno-oncology programs,
NantKwest’s goal is to transform medicine by delivering living
drugs in a bag and bringing novel NK cell-based therapies to
routine clinical care. NantKwest is a member of the NantWorks
ecosystem of companies. For more information, please visit
https://nantkwest.com.
haNK is a registered trademark of NantKwest, Inc.
About ImmunityBio
ImmunityBio is a privately held immunotherapy company with a
broad portfolio of biological molecules, including an
albumin-linked chemotherapeutic, peptides, fusion proteins,
cytokines, monoclonal antibodies, adenovirus, and yeast vaccine
therapies.
ImmunityBio’s oncological goals are two-fold: To employ the
company’s broad portfolio of biological molecules to activate
endogenous NK and CD8+ T cells, and to develop a T cell memory
cancer vaccine to combat multiple tumor types without the use of
high-dose chemotherapy.
The company’s platform of technologies has enabled it to achieve
one of the most comprehensive, late-stage clinical pipelines,
addressing both the innate (activated macrophage and natural killer
cell) and the adaptive immune system (dendritic, CD4 and CD8 killer
T cells). In 2020, ImmunityBio is planning to enroll patients in
late-stage trials with molecules across multiple indications
including triple negative breast cancer, lung cancer, head and neck
cancer, Merkel cell carcinoma and glioblastoma.
In the field of infectious disease, ImmunityBio’s goal is to
develop vaccine therapies for the prevention and treatment of
Influenza, Zika, Ebola, and HIV. For more information, please visit
our website at https://www.immunitybio.com/.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements include statements concerning or
implying that NantKwest will be successful in improving the
treatment of cancer. Risks and uncertainties related to this
endeavor include, but are not limited to, obtaining FDA approval of
NantKwest’s NK cells as well as other therapeutics as part of the
NANT Cancer Vaccine platform as a cancer treatment.
Forward-looking statements are based on management’s current
expectations and are subject to various risks and uncertainties
that could cause actual results to differ materially and adversely
from those expressed or implied by such forward-looking statements.
Accordingly, these forward-looking statements do not constitute
guarantees of future performance, and you are cautioned not to
place undue reliance on these forward-looking statements.
These and other risks regarding NantKwest’s business are
described in detail in its Securities and Exchange Commission
filings, including in NantKwest’s Quarterly Report on Form 10-Q for
the quarter ended September 30, 2019. These forward-looking
statements speak only as of the date hereof, and we disclaim any
obligation to update these statements except as may be required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20191216005233/en/
Media Contact: Jen Hodson 562-397-3639 Jen@nant.com
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