Phase Ib/II Clinical Trial Data Reported at
2019 Annual Meeting of the American Society of Clinical Oncology
Shows High Overall Objective Response Rate (ORR) of 58% and
Complete Response Rate (CR) of 33% in Relapsed/Refractory Lymphoma
Patients
NantKwest Inc. (Nasdaq:NK) announced today that its strategic
partner Viracta Therapeutics presented updated clinical data on its
HDAC inhibitor, nanatinostat (VRx-3996) at the Annual Meeting of
the American Society of Clinical Oncology (ASCO) in Chicago, IL,
from May 31st – June 4th, 2019.
In April 2017, NantKwest announced that it was the lead investor
in Viracta’s Series B financing round. Concurrent with the
financing, NantKwest secured an exclusive license with
commercialization rights to nanatinostat for use in combination
with natural killer (NK) cell therapies, including NantKwest’s NK
cell platforms.
Nanatinostat is a Class 1 histone deacetylase (HDAC) inhibitor
currently in phase Ib/II clinical trials (NCT03397706). In
preclinical studies, nanatinostat has been shown to reactivate
silenced transgenes in tumor cells thereby turning them into
preferential targets for NK cell killing, while also serving to
broadly stimulate a patient’s immune system, offering the potential
for improved clinical responses in cancer patients.
The activity of HDAC inhibitors are believed to be based on the
upregulation of natural killer group 2D (NKG2D) ligand expression
on cancer cells, which serve as “eat-me” signals for NK cells and
can drive NK proliferation, activation and cancer cell killing.
NantKwest is preparing to initiate clinical trials that include
nanatinostat in combination with its haNK and t-haNK cell therapy
platforms, which we believe will work synergistically to enhance
the efficacy of the company’s NK cell therapies and further
distinguish us in the market.
Interim results presented at the 2019 annual ASCO meeting from
the phase Ib portion of the ongoing phase Ib/II clinical trial of
nanatinostat was in combination with the antiviral valganciclovir
for the treatment of relapsed/refractory Epstein Barr Virus
(EBV)-associated lymphomas. Three doses of the combination were
evaluated with responses seen at all dose levels. Both drugs are
taken orally and can be administered in an out-patient setting.
EBV-associated cancers are known to be an extremely difficult
cancer to treat. Early clinical data with the combination of
nanatinostat and anti-viral therapy in EBV-associated lymphoma from
the phase Ib/II study has provided encouraging efficacy signals.
Currently, there are no approved treatments for EBV-associated
lymphomas that specifically target the virus.
The combination therapy produced an objective response rate
(ORR) of 58%, a complete response rate (CR) of 33% and a disease
stabilization rate (DSR) of 75%. Based on these encouraging
results, Viracta anticipates advancement of the clinical trial to
the phase II stage that will evaluate intermittent dosing of
nanatinostat (4 days on and 3 days off) in combination with daily
valganciclovir.
Patrick Soon-Shiong, M.D., Chairman and CEO of NantKwest
commented, “EBV-associated lymphomas represent a heterogenous group
of cancers that are often aggressive and poorly responsive to
available therapy. In this phase Ib stage, we are pleased to see
encouraging objective responses including a 33% complete response
rate in relapsed/resistant EBV positive cancer patients. We look
forward to our continued partnership with Viracta to transition to
phase II clinical trials, while also moving nanatinostat forward in
combination with NantKwest’s haNK and t-haNK cell therapies.”
Ivor Royston, M.D., Viracta’s CEO added, "Our ASCO presentation
and clinical trial update highlights the potential of our
proprietary 'Kick & Kill' therapeutic approach to treat a wide
range of EBV positive cancer patients, with responses seen across
all doses in both T cell and B cell lymphomas in our ongoing phase
Ib/II study. "This data enable us to move forward with the phase II
portion of our study with a well-tolerated dose combination of
nanatinostat with valganciclovir, which we expect to initiate in
the third quarter of 2019."
About Nanatinostat
Nanatinostat (VRx-3996) is a histone deacetylase (HDAC)
inhibitor that is being investigated in a range of clinical
indications. Nanatinostat is selective for Class 1 HDACs, including
isoforms targeted in Viracta's “Kick & Kill” therapeutic
approach. Viracta is investigating nanatinostat in a phase Ib/II
clinical study [NCT03397706] in combination with an antiviral
valganciclovir for the treatment of EBV-associated cancers. Both
drugs are taken orally and can be given on an out-patient basis.
Recently, the nanatinostat plus valganciclovir combination therapy
received Orphan Drug Designation (ODD) from the U.S. Food &
Drug Administration (FDA) for three sub-types of EBV-associated
cancers: post-transplant lymphoproliferative disorder (PTLD),
plasmablastic lymphoma, and angioimmunoblastic T cell lymphoma.
About EBV-Associated Cancers
Approximately 95% of the world's adult population is infected
with Epstein-Barr Virus (EBV). Infections are commonly asymptomatic
or associated with mononucleosis. Following infection, the virus
remains latent in a small subset of lymphatic cells for the
duration of the patients' life. Cells containing latent virus are
increasingly susceptible to malignant transformation. Patients who
are immunocompromised are at an increased risk of developing EBV
lymphomas. In addition, EBV is also associated with a variety of
solid tumors, including nasopharyngeal carcinoma and gastric
cancer.
About NantKwest
NantKwest, a member of the NantWorks ecosystem of companies, is
an innovative clinical-stage immunotherapy company focused on
harnessing the power of the innate immune system by using the
natural killer cell to treat cancer and virally induced infectious
diseases.
NantKwest is uniquely positioned to implement precision cancer
medicine, with the potential to change the current paradigm of
cancer care. Natural Killer (NK) cells are a safeguard in the human
body designed to recognize and detect cells under stress due to
cancer or viral infection. NantKwest’s “off-the-shelf” activated NK
cell platform is designed to destroy cancer and virally infected
cells from the body. The safety of our 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. In addition to being
a universal cell-based therapy that does not require individualized
patient sourcing or matching, our NK cell products have been
largely administered in the outpatient setting as an
“off-the-shelf” living drug.
With the capacity to grow active killer cells as a cancer
therapy, our NK cells have been designed to induce cell death
against cancers and virally infected cells by several mechanisms,
including: (i) innate killing, whereby all of our NK platforms
recognize the stress proteins typically found on cancer cells,
which, upon binding, release toxic granules to immediately kill
their targets; (ii) antibody-mediated killing with our haNK®
platform, which are NK cells engineered to express antibody
receptors that can bind to therapeutic antibody products, thereby
enhancing the cancer cell killing effect of that antibody; and
(iii) Chimeric Antigen Receptor directed killing using the taNK®
platform, which includes NK cells engineered to incorporate
chimeric antigen receptors (CARs) to target tumor-specific antigens
found on the surface of cancer cells. All three modes of killing
(innate, antibody-mediated, and CAR directed killing) are employed
by our t-haNK™ platform, which is an innovative combination of our
aNK, haNK® and taNK® platforms in a single product.
Our haNK®, and t-haNK™ platforms have been designed to address
certain limitations of CAR T-cell therapy including the capability
to infuse cell therapy in an outpatient setting which allows for
potential reduction of risk for serious cytokine storms and
protracted serious adverse events. In phase I and II clinical
trials in patients with late stage cancer, our NK cells have been
administered as an investigational outpatient infusion safely with
greater than 500 infusions to date at a dose of 2 billion cells per
infusion.
By leveraging an integrated and extensive genomics and
transcriptomics discovery and development engine, together with a
pipeline of multiple, clinical-stage, immuno-oncology programs, we
believe NantKwest is uniquely positioned to be the premier
immunotherapy company and transform medicine by delivering living
drugs in a bag and bringing novel NK cell-based therapies to
routine clinical care.
NK-92, aNK, haNK, taNK, and t-haNK are trademarks 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 March 31, 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.
About Viracta Therapeutics, Inc.
Viracta is a clinical-stage drug development company focused on
advancing novel epigenetic therapeutics derived from its
proprietary “Kick & Kill” therapeutic approach to benefit
patients with viral-associated cancers and other serious diseases.
Viracta has entered into partnerships with Shenzhen Salubris
Pharmaceutical Co., Ltd. to bring treatments for EBV-associated
cancers to China, and with NantKwest, Inc. to utilize nanatinostat
in combination with their clinical-stage Natural Killer (NK) cell
immunotherapy. Viracta plans to enter into additional geographic
and combination therapy partnerships.
For additional information please visit www.nantkwest.com or
www.viracta.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20190604005474/en/
Media Contact:Jen Hodson562-397-3639Jen@nant.com
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