Nkarta Establishes New Combined NK Cell Therapy Manufacturing Facility / Company Headquarters
July 14 2021 - 7:00AM
Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing
engineered natural killer (NK) cell therapies to treat cancer,
today announced that it has signed a lease agreement for a facility
to support research and development and future commercial
manufacturing of Nkarta’s cell therapy pipeline. The new facility
will also serve as the company’s headquarters with office space and
research facilities. The manufacturing center will be custom
designed to complement Nkarta’s state-of-the-art technology
platform and optimize the production of its multiple off-the-shelf
NK cell therapy investigational products. Nkarta plans to produce
materials for potential pivotal clinical trials and commercial
launch at the new center.
“Our goal is to ensure that cost-effective, commercial-scale
production of cell therapies can be made available widely and
rapidly to the cancer patients who need them, and we expect this
new facility will enable us to do just that,” said Paul J.
Hastings, President and CEO of Nkarta. “As we advance our NKX101
and NKX019 clinical programs and enhance our proprietary platform
with exciting new capabilities like CRISPR Cas9 genome engineering,
we believe our expanded footprint will drive continued operational
excellence and accelerate the development of transformative NK cell
therapies for a broad range of cancers.”
Earlier this year, Nkarta completed the construction and
qualification of a 2,700 square foot cGMP facility at its primary
location in South San Francisco, California. This current clinical
manufacturing facility was designed to integrate with Nkarta’s
internal process development expertise and meet the production
needs of Nkarta’s research activities and early stage clinical
trials. Nkarta is currently manufacturing clinical supply for its
planned Phase 1 study of NKX019, expected to start in the second
half of 2021, and plans to transfer the production of NKX101 and
other proprietary platform materials to the clinical manufacturing
facility in the future.
The newly leased facility in South San Francisco will be
built-out as a multi-product facility and is expected to be
operational by the end of 2023. At full capacity, the manufacturing
center is expected to have the flexibility to produce commercial
supply of multiple cell therapy products. Nkarta will also
consolidate administrative offices and research and development
laboratories at the new site.
About NKX101 NKX101 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 NKX019NKX019 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 a CD19-directed chimeric antigen receptor (CAR) and
a proprietary, membrane-bound form of interleukin 15 (IL-15). CD19
is a biomarker for normal and malignant B cells, and it is a
validated target for B cell cancer therapies. Via its CAR, NKX019
targets and binds to CD19 and eliminates CD19-expressing cells via
a robust immune response in preclinical studies. Preclinical models
also demonstrate enhanced proliferation, persistence and activity
of NK cells with the membrane-bound IL-15, an important cytokine
for NK cell survival. Initiation of a Phase 1 clinical trial of
NKX019 in patients with relapsed/refractory B cell malignancies in
multiple centers in the United States and Australia is planned for
the second half of 2021.
About Nkarta’s Platform and Natural Starting
MaterialsNkarta’s engineering platform utilizes healthy
adult donors as the source for NK cells. By enlisting this natural
source of NK cells, Nkarta starts with bona fide NK cells endowed
with inherent tumor-recognizing ability and potent cytotoxic
function. Healthy donor-derived NK cells are also available in
abundance, providing a large quantity of cells with which to begin
the efficient two-week manufacturing process. Finally, healthy
donor-derived adult cells consist of a diverse repertoire of NK
cells, providing Nkarta with the potential to capitalize on the
inherent diversity of the innate immune system in selecting donors
or NK cell populations with optimal characteristics.
About Nkarta’s NK Cell TechnologiesNkarta 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.
To enhance the inherent biological activity of NK cells, Nkarta
genetically engineers the cells with 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 current cell therapy candidates are also 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
patients. 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 the future benefits and impact of the new facility;
Nkarta’s plans for the use of the facility; the efficiency and cost
of Nkarta’s manufacturing processes and operations, including for
commercial-scale manufacturing; the capacity of the future
manufacturing facility and the timeline for it to be operational;
the expected timing of the NKX019 trial initiation; Nkarta’s
ability to manufacture clinical supply of NKX019 in house and
transfer production of NKX101 in house; Nkarta’s ability to
capitalize on the inherent diversity of the innate immune system;
the ability of Nkarta’s technology to enhance the proliferation,
persistence and anti-tumor activity of NK cells and enable
off-the-shelf, point-of-care administration; 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; the complexity of the manufacturing
process for CAR NK cell therapies; 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 Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 2021, filed with the SEC on May 13, 2021, 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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