NantKwest Announces Presentation of Positive Phase 2 Clinical Data of Natural Killer Cell Therapy in Metastatic Merkel Cell C...
November 07 2019 - 4:15PM
Business Wire
Durable Responses Demonstrated in 2 of 7
Patients with Refractory Metastatic MCC
Data Supportive of Planned Off-the-Shelf
Clinical Trial to Confirm Activity and Safety
NantKwest Inc. (Nasdaq: NK), a next generation, clinical-stage
immunotherapy company focused on harnessing the unique power of our
immune system using natural killer (NK) cells to treat cancer,
infectious diseases and other diseases, today announced the
presentation of results from their Phase 2 trial investigation
using aNK, NantKwest’s off-the-shelf natural killer cell-based
therapeutic, in combination with N-803, ImmunityBio’s IL-15
superagonist, in patients with advanced refractory metastatic
Merkel cell carcinoma (MCC) (NCT03853317) at The 34th Annual
Meeting of the Society for Immunotherapy for Cancer (SITC 2019) on
November 8, 2019 in National Harbor, Maryland. ImmunityBio is an
affiliate company of NantKwest.
Dr. Shailender Bhatia, Associate Professor of Medical Oncology
at the University of Washington/Fred Hutchinson Cancer Research
Center, will make an oral presentation entitled “Final results from
a phase 2 study using off-the-shelf activated natural killer (aNK)
cells in combination with N-803, an IL-15 superagonist, in patients
with metastatic Merkel cell carcinoma (MCC).” That study
demonstrated long term, durable responses in 2 of 7 patients with
advanced refractory MCC. One of these patients achieved a
radiologic complete response, and the second a durable partial
response with more than 75% tumor regression and no subsequent
therapy (response ongoing to date). Both patients with responses in
the trial remain alive to date, 29 and 44 months after the
initiation of treatment.
Results from this study provide evidence that treatment with aNK
cell therapy can stimulate immune responses to checkpoint
inhibitors, even in patients that have previously failed treatments
using these types of therapies. One heavily pretreated subject
refractory to pembrolizumab was rechallenged with this checkpoint
inhibitor subsequent to receiving aNK cell therapy resulting in a
durable complete response (CR) that is ongoing at this time, 44
months after receipt of first aNK cell infusion.
“We believe the results of this Phase 2 study are testament to
the potential of our natural killer cell-based therapeutics to
change the cancer treatment paradigm,” said Dr. Patrick
Soon-Shiong, Chairman and CEO of NantKwest. “Long term responses in
patients with refractory metastatic disease is a remarkable
achievement and is supportive of our upcoming trial, which will
evaluate NantKwest’s off-the-shelf CD16-targeted haNK cells in
combination with N-803 and Pfizer’s avelumab in patients with
advanced MCC who are refractory to immune checkpoint inhibitors. We
are particularly enthusiastic about the potential of aNK and N-803
to induce sensitization to checkpoint inhibitors, and thus, are
evaluating this in our upcoming trial. We remain deeply committed
to harnessing the power of immunogenic cell death across a wide
range of indications to provide innovative treatments to patients
with serious unmet need.”
Other presentation highlights include:
- Overall response rate of 29% (2 of 7 patients)
- Evidence that aNK cell treatment may induce sensitivity to
immune checkpoint inhibitors with a patient previously refractory
to pembrolizumab demonstrating an ongoing complete response to the
checkpoint inhibitor after completing aNK cell therapy
- aNK cell therapy resulted in increased levels of
tumor-infiltrating lymphocytes and increased immune
response-related gene expression within tumor tissue
- aNK cells in combination with N-803 were well-tolerated, with
no treatment-related serious adverse events or grade ≥3 adverse
events
- Infusions all safely administered in the outpatient setting
without observed immune related adverse events
Dr. Bhatia said, “Merkel cell carcinoma (MCC) is an aggressive
skin cancer that is estimated to be three times more deadly than
melanoma. PD-1 blockade works well for around 50 percent of
patients with metastatic disease, but a significant proportion do
not respond or progress later. Innate immunotherapy approach using
aNK cells can potentially overcome resistance mechanisms in PD-1
refractory tumors. I am particularly enthusiastic about the
preliminary results of the MCC study, with two complete responses
in patients with very advanced metastatic disease.”
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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Jen Hodson 562-397-3639 Jen@nant.com
NantKwest (NASDAQ:NK)
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