NantKwest Announces Phase 1 Results for First-in-Human PD-L1 Tumor-Targeted Natural Killer Cells (PD-L1.t-haNK) in Patients w...
December 02 2019 - 4:05PM
Business Wire
First-in-human trial shows no dose-limiting
toxicities in six subjects treated as out-patients with
PD-L1.t-haNK off-the-shelf CAR NK cell therapy with potential to
overcome limitations of CAR-T therapies for solid tumors
NantKwest, Inc. (Nasdaq: NK), a clinical-stage natural killer
cell-based therapeutics company, today announced promising safety
data generated from the first six patients in its QUILT-3.064
trial. The first-in-human study evaluated the safety and
preliminary efficacy of the Company’s first-in-class,
tumor-targeted PD-L1.t-haNK cell therapy in patients with locally
advanced or metastatic solid tumors.
“The unique dual-targeting of PD-L1.t-haNK to both PD-L1
expressing tumors and therapeutic monoclonal antibodies has the
potential to be transformative to the treatment of advanced solid
tumors with cell-based therapies,” said Dr. Patrick Soon-Shiong,
the Chairman and CEO of NantKwest. “PD-L1.t-haNK is a
cryopreserved, off-the-shelf product that can rapidly deliver
treatment to patients in an outpatient setting while avoiding the
extensive manufacturing delays associated with autologous CAR-T
therapies. We look forward to reporting full study results from the
phase 1 cohort and moving toward a recommended phase 2 dose. We
continue to advance our innovative cell therapies such as
PD-L1.t-haNK in combination with ImmunityBio’s N-803, an IL-15
superagonist that is designed to stimulate the activation and
proliferation of the patient’s own NK cells to maximize the
potential of immunogenic cell death to treat cancer,” continued
Soon-Shiong. NantKwest and a wholly owned subsidiary of ImmunityBio
have entered into an exclusive collaboration agreement to
co-develop NantKwest’s proprietary off-the-shelf NK platforms in
combination with N-803.
On December 2, 2019 at the NantKwest Key Opinion Leader and
Investors conference, Dr. Soon-Shiong described the clinical
development plans for two of NantKwest’s first-in-class NK
products: haNK, which was developed to target binding to approved
monoclonal therapies such as Trastuzumab, Rituximab and Cetuximab;
and PD-L1.t-haNK, which was also designed to target these approved
therapies plus directly target PD-L1-expressing tumor cells.
PD-L1.t-haNK cells are a human-derived, allogeneic, natural
killer cell line engineered to express a chimeric antigen receptor
(CAR) targeting PD-L1, whose origins arise from NantKwest’s
proprietary NK-92 (aNK) master cell bank. In addition to targeting
PD-L1, PD-L1.t-haNK is engineered to produce intracellular IL-2 for
enhanced CD16-targeted antibody-dependent cellular cytotoxicity
capabilities.
John Lee, M.D., Clinical Senior Vice President at NantKwest,
said, “We are highly encouraged by the early safety results with
PD-L1.t-haNK in a patient population with advanced, difficult to
treat solid tumors. All patients were able to be infused in the
outpatient setting without any reported cytokine toxicities or
immune related adverse events. NantKwest’s approach has been
designed to overcome the challenges and limitations typically seen
when treating solid tumors with CAR-T and other immunotherapy
approaches and I look forward to progressing our studies to advance
this innovative new approach to cancer therapy.”
Study Design
The QUILT-3.064 study is an open-label, Phase 1 study of
PD-L1.t-haNK in subjects with locally advanced or metastatic solid
cancers to evaluate safety, preliminary efficacy, determine maximum
tolerated dose (MTD) or highest tolerated dose (HTD) and designate
the recommended Phase 2 dose (RP2D). The study is being conducted
in two parts: the first is evaluating dose escalation using a 3 + 3
design and the second part will evaluate the expansion of the
recommended Phase 2 dose (RP2D) to further assess the safety and
efficacy of PD-L1.t-haNK therapy. In part one, six subjects were
sequentially enrolled, starting at dose level 1 and assessed for
dose-limiting toxicities. The primary study objectives are to
determine the MTD or HTD, RP2D (recommended phase 2 dose), and
safety. The secondary endpoints include objective response rate
(ORR), progression free survival (PFS) and overall survival (OS).
More information can be found at ClinicalTrials.gov, Identifier:
NCT04050709.
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.
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/20191202005793/en/
Media Contact: Jen Hodson Jen@nant.com 562-397-3639
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