- Third cohort added to independently evaluate the efficacy
of NantKwest’s PD-L1 t-haNK natural killer cells plus ImmunityBio’s
IL-15 superagonist Anktiva™ (N-803) in third-line or greater
therapy for patients with locally advanced or metastatic pancreatic
cancer.
- Two other cohorts for first-line maintenance and second-line
randomized against standards of care chemotherapy.
- 40 patients are currently enrolled in or being evaluated for
the Phase 2 trial at three sites.
- Metastatic pancreatic cancer patients treated with PD-L1 t-haNK
and Anktiva (N-803) through single-patient Expanded Access INDs
continue to have ongoing stable disease and a durable complete
response >11 months after initial treatment.
NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer
cell-based therapeutics company, and ImmunityBio, a privately-held
immunotherapy company, today announced they have added a third
cohort to their ongoing Phase 2 trial of a novel immunotherapy for
locally advanced or metastatic pancreatic cancer. The third cohort
enables pancreatic cancer patients who have failed all approved
standards of care to participate in the trial.
The randomized, open-label study is evaluating safety and
efficacy of a combination immunotherapy comprising NantKwest’s
PD-L1 t-haNK, ImmunityBio’s IL-15 superagonist Anktiva (N-803), and
aldoxorubicin, plus standard of care. The results will be compared
to standard-of-care chemotherapy for first- and second-line
treatment; the third-line cohort is a single arm, with no
comparator. Each cohort will be studied independently to provide
more precise comparative data for each disease stage.
“Pancreatic cancer is one of the deadliest forms of cancer, with
a five-year survival rate of just five percent, so new and more
effective therapies are desperately needed,” said Patrick
Soon-Shiong, M.D., Chairman and Chief Executive Officer of
NantKwest and ImmunityBio. “By adding the third cohort to this
important study, we’re able to enroll patients at all stages of the
disease, even those who experience disease progression after the
first- or second-line treatment.”
Trial Sites and Enrollment
Currently, three trial sites have been activated: Hoag Memorial
Hospital Presbyterian in Orange County, Calif., The Chan
Soon-Shiong Institute for Medicine in Los Angeles County, Calif.,
and Avera McKennan Hospital and University Health Center in Sioux
Falls, South Dakota, which will serve patients in the tri-state
area (Iowa, Nebraska and South Dakota). Forty patients are
currently enrolled in or being evaluated for the trial.
NantKwest and ImmunityBio’s combination immunotherapy is
designed to harness the body's immune system to target, kill, and
"remember" cancer cells. The agents in this trial are designed to
find pancreatic cancer cells and initiate a large immune response
against them. This may allow the body to develop its own antibodies
to fight the cancer.
“Our research in pancreatic cancer, as well as many other forms
of cancer, is focused on how we can recruit and amplify the power
of the human body’s own immune system to target and destroy even
the most difficult cancer cells,” said Dr. Soon-Shiong. “Our goal
is to attack the disease aggressively so that we can provide more
time and a higher quality of life to patients who today have a very
poor prognosis.”
Study Details
This Phase 2, randomized, three-cohort, open-label study will
evaluate the comparative efficacy and overall safety of
standard-of-care chemotherapy versus standard-of-care chemotherapy,
in combination with PD-L1 t-haNK, Anktiva (N-803), and
aldoxorubicin in subjects with locally advanced or metastatic
pancreatic cancer (QUILT-88, NCT04390399). Each treatment setting,
as well as each first- and second-line or later maintenance
treatment, will be evaluated independently as Cohort A, Cohort B,
and Cohort C, respectively, with cohorts A and B having independent
experimental and control arms. The study will initially enroll 298
subjects across all three cohorts. The primary objective of cohorts
A and B is progression-free survival (PFS) and the objective of
cohort C is overall survival (OS) per RECIST V1.1. Secondary
objectives include initial safety and additional efficacy measures,
including overall response rate (ORR), complete response (CR) rate,
durability of response (DoR), disease control rate (DCR), and
overall survival (OS).
Pancreatic cancer is the fourth leading cause of cancer-related
death in the US, with an estimated 47,050 deaths and 57,600 new
cases expected in 2020.1. It is the 12th most common cancer
worldwide, with around 338,000 new cases diagnosed in 2012 (2% of
all cancer diagnoses).
1.Siegel RL, Miller KD, and Jemal A. Cancer statistics, 2020. CA
Cancer J Clin. 2020;70:7-30
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 infectious diseases. NantKwest is
the leading producer of clinical dose forms of off-the-shelf
natural killer (NK) cell therapies. The activated NK cell platform
is designed to destroy cancer and virally-infected cells. The
safety of these optimized, activated NK cells—as well as their
activity against a broad range of cancers—has 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 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
www.nantkwest.com
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 or other critical illnesses, including
COVID-19. Risks and uncertainties related to these endeavors
include, but are not limited to, obtaining FDA approval of
NantKwest’s NK cells and MSC as well as other therapeutics and
manufacturing challenges.
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 June 30, 2020. 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 ImmunityBio
ImmunityBio, Inc. is a late-clinical-stage immunotherapy company
developing next-generation therapies that drive immunogenic
mechanisms for defeating cancers and infectious diseases. The
company’s immunotherapy platform activates both the innate (natural
killer cell and macrophage) and adaptive (T cell) immune systems to
create long-term “immunological memory.” This novel approach is
designed to eliminate the need for high-dose chemotherapy, improve
upon the outcomes of current CAR T-cell therapies, and extend
beyond checkpoint inhibitors.
ImmunityBio’s platform is based on the foundation of three
separate modalities: antibody cytokine fusion proteins, synthetic
immunomodulators, and second-generation human adenovirus (hAd5)
vaccine technologies.
Anktiva™ (ImmunityBio’s lead cytokine infusion protein) is a
novel interleukin-15 (IL-15) superagonist complex and has received
Breakthrough Therapy and Fast Track Designations from the U.S. Food
and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle
invasive bladder cancer (NMIBC). The company is also in Phase 2 or
3 trials for indications such as first- and second-line lung
cancer, triple-negative breast cancer, metastatic pancreatic
cancer, recurrent glioblastoma, and soft tissue sarcoma in
combination with the company’s synthetic immune modulator
(aldoxorubicin).
ImmunityBio is also developing therapies, including vaccines,
for the prevention and treatment of HIV, influenza, and the
coronavirus SARS-CoV-2 with its second-generation human adenovirus
(hAd5) vaccine technologies.
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 ImmunityBio will be successful in improving the
treatment of various diseases, including, but not limited to the
novel coronavirus and cancer. Risks and uncertainties related to
this endeavor include, but are not limited to, the company’s
beliefs regarding the success, cost, and timing of its development
activities and clinical trials.
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
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/20201006005985/en/
Media Contact: Jen Hodson Jen@nant.com 562-397-3639
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