Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical
company developing engineered natural killer (NK) cell therapies to
treat cancer, today announced that the first patient has been
treated in the first-in-human Phase 1 clinical trial of NKX101 for
the treatment of relapsed/refractory acute myeloid leukemia (AML)
or higher risk myelodysplastic syndromes (MDS). The multi-center
clinical trial is designed to evaluate safety, pharmacokinetics,
and preliminary anti-tumor activity of NKX101.
NKX101 is the first investigational NK cell cancer immunotherapy
engineered to express a chimeric activating receptor (CAR)
targeting NKG2D. NKG2D, a key activating receptor found on
naturally occurring NK cells, induces a cell-killing immune
response through the detection of stress ligands that are widely
and specifically expressed on cancer cells. With NKX101, NKG2D
expression is increased by 10-fold and cytotoxic activity increased
by 4-fold compared to non-engineered NK cells in preclinical
models. NKX101 is also designed to express membrane-bound IL-15,
which in preclinical models enhances the activity and persistence
of the engineered NK cells. Nkarta’s proprietary manufacturing
processes enable the evaluation of cryopreserved NKX101, expanding
trial access across multiple clinical centers.
"Despite recent treatment breakthroughs, AML patients who
relapse after front-line therapy still have poor outcomes,
underscoring the need for new treatment options for this aggressive
and lethal blood cancer,” said Carlos Bachier, M.D., Director of
Cellular Therapy Research, Sarah Cannon Research Institute and
Program Director for Sarah Cannon Center for Blood Cancer at
TriStar Centennial Medical Center in Nashville, Tennessee, where
the first patient has been treated. “To date, the significant
clinical benefit achieved with CAR T cell therapies in the
treatment of B cell lymphomas and acute lymphocytic leukemia has
not extended to AML or other myeloid malignant disorders. The
investigation of NKG2D-targeting and the tumor-killing potential of
an engineered innate immune cell type is a promising new
approach.”
“An extensive body of academic research has already shown
increased expression of NKG2D targets in AML and other cancers, and
demonstrated clinical responses in relapsed/refractory AML patients
who received non-engineered allogeneic NK cells in single center
academic studies as treatment,” said Kanya Rajangam, M.D., Ph.D.,
Chief Medical Officer of Nkarta. “With its amplified NKG2D
targeting and enhanced NK cell engineering, NKX101 has the
potential to improve upon this earlier clinical experience with
non-engineered NK cells and to activate a deep and robust immune
response in AML patients.”
A poster on the design of the NKX101 clinical trial in progress
has been accepted for presentation at the 2020 American Society of
Hematology Annual Meeting and Exhibition, Abstract 1040, “A Phase 1
Study of NKX101, an Allogeneic CAR Natural Killer (NK) Cell
Therapy, in Subjects with Relapsed/Refractory (R/R) Acute Myeloid
Leukemia (AML) or Higher-Risk Myelodysplastic Syndrome (MDS),”
Session 616, December 5, 2020.
About the Phase 1 Clinical Trial of
NKX101 in Participants with Relapsed/Refractory Acute Myeloid
Leukemia (AML) or Higher Risk
Myelodysplastic Syndromes (MDS)This
First-in-Human Phase 1 study evaluates the safety,
pharmacokinetics, and preliminary anti-tumor activity of NKX101,
administered in a cycle of three weekly infusions following
lymphodepletion, in adult patients living with relapsed/refractory
AML or higher risk MDS. This single-arm, open-label, multi-center
study consists of sequential dose-finding and dose-expansion. The
safety of participants will be monitored by assessment of vital
signs, physical examinations and laboratory tests. The clinical
trial is designed to identify a recommended Phase 2 dose, and will
evaluate cellular kinetics, pharmacodynamics, and preliminary
anti-tumor activity using standard response criteria. Additional
information is available on ClinicalTrials.gov, identifier
NCT04623944.
About AML and MDSAcute Myeloid Leukemia (AML)
is a rapidly progressing blood cancer caused by abnormalities of
myeloid cells, a cell type in the bone marrow that would normally
develop into different types of blood cells. AML usually worsens
rapidly and can lead to death if not treated. Despite recent
advancements, an unmet need for novel treatment options remains
high. Only approximately one in four patients with AML survive
longer than five years. Patients with AML have a high rate of
disease relapse after a treatment response. Due to age and
comorbidities, not all patients are eligible to receive intensive
chemotherapy, leaving them with limited treatment options. Once
relapsed or refractory to front-line therapy, patients have limited
treatment options. The worldwide incidence of AML was estimated to
be more than 119,500 cases in 2017.* In the United States, there
will be an estimated 19,940 new cases of AML in 2020, with an
estimated 11,180 deaths resulting from the disease.**
Myelodysplastic Syndromes (MDS) are a group of bone marrow
disorders in which the blood-forming cells in the bone marrow do
not produce enough healthy blood cells. Some patients with MDS have
too many young, immature blood-making cells in the bone marrow. The
median overall survival rate of higher risk MDS patients is 0.8 to
3.0 years. There is currently no curative treatment for patients
who relapse after front-line therapy or do not respond to
front-line therapy. MDS can progress to AML in about one-third of
patients.
*Ming Yi et al, J Hematol Oncol. 2020; 13: 72; **National
Institutes of Health, Cancer Stat Facts, accessed 11 Nov 2020.
About NKX101NKX101 is an investigational,
off-the-shelf cancer immunotherapy that uses natural killer (NK)
cells derived from the peripheral blood of healthy donors and
engineered with membrane-bound IL15 and a chimeric antigen receptor
(CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key
activating receptor found on naturally occurring NK cells, induces
a cell-killing immune response through the detection of stress
ligands that are widely expressed on cancer cells. By engineering
NKX101 with the proprietary NKG2D-based CAR, the ability of NK
cells to recognize and kill tumor cells in pre-clinical models is
increased significantly compared to non-engineered NK cells. The
addition of membrane-bound IL15, a proprietary version of a
cytokine for activating NK cell growth, has been shown in
pre-clinical models to enhance the proliferation, persistence and
sustained activity of NK cells. A multi-center Phase 1 clinical
trial of NKX101 in patients with relapsed/refractory acute myeloid
leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is
currently enrolling. Additional information about the clinical
trial is available on ClinicalTrials.gov, identifier
NCT04623944.
About Nkarta’s NK Cell
Technologies Nkarta has pioneered a novel discovery and
development platform for the engineering and efficient production
of allogeneic, off-the-shelf natural killer (NK) cell therapy
candidates. The approach harnesses the innate ability of NK cells
to recognize and kill tumor cells, and builds upon the important
advances in cellular immunotherapy and chimeric antigen receptor
(CAR) biology. To enhance the intrinsic activity of NK cells,
Nkarta genetically engineers the cells with a CAR that consists of
a targeting receptor designed to recognize and bind to specific
proteins on the surface of cancerous cells. This receptor is fused
to co-stimulatory and signaling domains to amplify cell signaling
and NK cell cytotoxicity. Upon binding the target, NK cells become
activated and release cytokines that enhance the immune response
and cytotoxic granules that lead to killing of the target cell. All
of Nkarta’s NK cell therapy candidates are engineered with a
membrane-bound IL15, a proprietary version of a cytokine known for
activating NK cell growth, to enhance the persistence and activity
of the NK cells.
Nkarta’s manufacturing process generates an abundant supply of
NK cells that, at commercial scale, is expected to be significantly
lower in cost than other current allogeneic and autologous cell
therapies. Key to this efficiency is the rapid expansion of
donor-derived NK cells using a proprietary NKSTIM cell line,
leading to the production of hundreds of individual doses from a
single manufacturing run. The platform also features the ability to
freeze and store CAR NK cells for an extended period of time and is
designed to enable immediate, off-the-shelf administration to
patients at the point of care.
About NkartaNkarta is a clinical-stage
biotechnology company advancing the development of allogeneic, off
the shelf natural killer (NK) cell therapies for cancer. By
combining its cell expansion and cryopreservation platform with
proprietary cell engineering technologies, Nkarta is building a
pipeline of cell therapy candidates generated by efficient
manufacturing processes, which are engineered to enhance tumor
targeting and improve persistence for sustained activity in the
body. For more information, please visit the company’s website at
www.nkartatx.com.
Cautionary Note on Forward-Looking Statements
Statements contained in this press release regarding matters that
are not historical facts are “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended. Words such as "anticipates," "believes,"
"expects," "intends," “plans,” “potential,” "projects,” “would” and
"future" or similar expressions are intended to identify
forward-looking statements. Examples of these forward-looking
statements include statements concerning Nkarta’s expectations
regarding: Nkarta’s growth, strategy, progress and timing of its
preclinical studies and clinical trials for NKX101; the mechanism
of action and activity of Nkarta’s product candidates, including
the activity of NKX101 in AML patients; NKX101’s potential as a
treatment for AML; the size of the AML market; the efficiency and
cost of Nkarta’s manufacturing processes; the number of doses
generated from a manufacturing run; and the proprietary nature of
Nkarta’s technology. Because such statements are subject to risks
and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. These
risks and uncertainties include, among others: Nkarta’s limited
operating history and historical losses; Nkarta’s ability to raise
additional funding to complete the development and any
commercialization of its product candidates; Nkarta’s dependence on
the success of its co-lead product candidates, NKX101 and NKX019;
that Nkarta may be delayed in initiating, enrolling or completing
any clinical trials; competition from third parties that are
developing products for similar uses; Nkarta’s ability to obtain,
maintain and protect its intellectual property; Nkarta’s dependence
on third parties in connection with manufacturing, clinical trials
and pre-clinical studies; and risks relating to the impact on our
business of the COVID-19 pandemic or similar public health
crises.
These and other risks are described more fully in Nkarta’s
filings with the Securities and Exchange
Commission (“SEC”), including the “Risk Factors” section of
Nkarta’s final prospectus for its initial public offering, filed
with the SEC on July 13, 2020, Nkarta’s Quarterly Report on Form
10-Q for the quarterly period ended June 30, 2020, filed with
the SEC on August 20, 2020, and our other documents
subsequently filed with or furnished to the SEC. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except to the extent
required by law, Nkarta undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Nkarta Media/Investor Contact:Greg MannNkarta,
Inc.gmann@nkartatx.com
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