Pivotal QUILT 88 trial based on combination
immunotherapy of “Cancer Moonshot” strategy; early indications of
increased survival rate for pancreatic cancer patients with no
other approved treatment options
- In initial Cancer Moonshot QUILT trials of haNK and avelumab
(PD-L1 checkpoint inhibitor) completed in 2019, median overall
survival rate more than doubled compared to historical controls
(eight months versus three months)
- A complete remission was achieved when replacing haNK and PD-L1
checkpoint inhibitor avelumab with PD-L1 t-haNK and four out of
five patients are alive 8-16 months since beginning treatment on
these expanded protocols
- Based on this encouraging early data, a single-arm Phase 2
study (QUILT 88, Cohort C) was initiated in October 2020, for which
the primary endpoint is overall survival and 15 out of 18 (83%) of
patients enrolled with second-line or greater pancreatic cancer
remain alive to date
- Randomized trials in first- and second-line pancreatic cancer
are actively recruiting at three sites with more than 50 patients
enrolled or being evaluated in QUILT 88 to date
NantKwest, Inc. (NASDAQ: NK), a clinical-stage,
natural killer cell-based therapeutics company, and ImmunityBio,
Inc., a privately-held immunotherapy company, today announced early
interim results of its PD-L1 t-haNK protocols showing median
survival rates more than doubled that of the historic rate in
patients with advanced metastatic pancreatic cancer for which no
other FDA-approved treatment exists. These trials, which were based
on the original Cancer Moonshot hypothesis and exploratory QUILT
trials initiated in 2017, appear to validate the theory that by
orchestrating natural killer and T-cell therapy, survival rates
could be improved without high-dose chemotherapy.
The early collaborative Cancer Moonshot trials involved the
combination of cell therapy and immunotherapeutics from multiple
biotech and pharmaceutical companies, including NantKwest,
ImmunityBio, Celgene, and Pfizer. These trials explored the
hypothesis that by activating the patient’s own immune system, a
paradigm change in cancer therapy could evolve to eradicate cancer
cells without high-dose chemotherapy. From 2017 to 2020, multiple
QUILT clinical trials exploring this combination of cell therapy,
immunomodulating antibodies, adenovirus-based cancer vaccines, and
low-dose chemotherapy provided preliminary results showing the
median survival rate can be more than doubled and a complete
remission can be achieved in patients with metastatic pancreatic
cancer for which there are no other FDA-approved treatment options.
Based on the data from these trials, ImmunityBio is conducting a
pivotal, three-cohort pivotal trial (QUILT 88) in metastatic
pancreatic cancer.
Interim Study Results
- In the Cancer Moonshot QUILT trials of haNK combined with PD-L1
inhibitor avelumab, which were completed in 2019, the median
overall survival rate more than doubled (three months historic
control versus 8 months in the treatment arm) in the 12-patient
study. See related press release here for details.
- A complete remission was achieved when replacing haNK and PD-L1
inhibitor avelumab with PD-L1 t-haNK and four out of five patients
who had not yet reached median survival time (three months) are
alive 8-16 months since beginning treatment on these expanded
protocols
- A single-arm Phase 2 study (QUILT 88, Cohort C) was initiated
in October 2020, for which the primary endpoint is overall survival
and 15 out of 18 (83%) of patients enrolled with second-line or
greater pancreatic cancer remain alive to date.
- A randomized Phase 2 study (QUILT 88, Cohorts A and B) for
first- and second-line metastatic pancreatic cancer is actively
enrolling at three sites.
“The goal of the Cancer Moonshot program was to explore the
hypothesis that by orchestrating natural killer cells and T cells,
a paradigm change for the treatment of cancer could evolve. The
initial results of these Cancer Moonshot trials combining
immunotherapy molecules—including Abraxane from Celgene, haNK from
NantKwest, Anktiva from ImmunityBio, and a PD-L1 inhibitor Avelumab
from Pfizer—provided promising early data that a doubling of median
overall survival rate in patients with advanced metastatic disease
across multiple tumor types was possible,” said Patrick
Soon-Shiong, M.D., Chairman, and CEO of ImmunityBio.
“For five patients for whom no other treatment was available, we
replaced haNK and avelumab with the investigational NK cell therapy
PD-L1 t-haNK and were pleased to observe a complete remission in
the first patient to receive this combo therapeutic,” continued
Soon-Shiong. “To date, four out of five of these patients remain
alive since beginning treatment. These observations confirmed the
promise of our hypothesis that activating the patient’s own immune
system with low-dose chemo immunomodulation therapy could improve
outcomes. On the basis of our initial studies, we initiated our
QUILT 88 randomized trials in metastatic pancreatic cancer and are
pleased to present today those findings, including Cohort C
survival rates. While this data is still early, a doubling of the
survival rate is encouraging and warrants further confirmation
through QUILT 88.”
QUILT 88 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).
Cancer Moonshot QUILT trial numbers include QUILT 3.039, 3.060,
3.070, and 3.080.
QUILT 88 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). More than 50 patients are
currently enrolled in or being evaluated for the trial.
Pancreatic cancer is the fourth leading cause of cancer-related
death in the U.S., with an estimated 47,050 deaths and 57,600 new
cases expected in 2020. It is the 12th most common cancer
worldwide, with around 338,000 new cases diagnosed in 2012 (2% of
all cancer diagnoses). Pancreatic cancer continues to increase
today with no standard of care available for patients beyond second
line. A clear unmet medical need exists in these patients with
short expected survival time and high levels of existing
comorbidities.
NantKwest Transaction
As previously announced, on December 21, 2020, ImmunityBio
entered into an agreement to combine in a stock-for-stock
transaction with NantKwest. The combination, which is expected to
close in the first half of 2021, would create a leading
immunotherapy and cell therapy company focused on oncology and
infectious disease.
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.
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
1 clinical trials in Canada and Europe, as well as in multiple
Phase 1 and 2 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 presentation contains forward-looking statements relating
to the proposed transaction involving NantKwest, Inc. (“NantKwest”)
and ImmunityBio, Inc. (“ImmunityBio”), including financial
estimates and statements as to the expected timing, completion and
effects of the proposed transaction and statements relating to
NantKwest and ImmunityBio’s future success in improving the
treatment of various diseases and illnesses, including, but not
limited to COVID-19 and cancer. Statements in this communication
that are not statements of historical fact are considered
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the “Securities Act”), and
Section 21E of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), which are usually identified by the use of words
such as “anticipates,” “believes,” “continues”, “could”,
“estimates,” “expects,” “intends,” “may,” “plans,” “potential”,
“predicts”, “projects,” “seeks,” “should,” “will,” and variations
of such words or similar expressions. These forward-looking
statements are neither forecasts, promises nor guarantees, and are
based on the current beliefs of NantKwest’s management and
ImmunityBio’s management as well as assumptions made by and
information currently available to NantKwest and ImmunityBio. Such
statements reflect the current views of NantKwest and ImmunityBio
with respect to future events and are subject to known and unknown
risks, including business, regulatory, economic and competitive
risks, uncertainties, contingencies and assumptions about NantKwest
and ImmunityBio, including, without limitation, (i) inability to
complete the proposed transaction because, among other reasons,
conditions to the closing of the proposed transaction may not be
satisfied or waived, (ii) uncertainty as to the timing of
completion of the proposed transaction, (iii) potential adverse
effects or changes to relationships with employees, suppliers or
other parties resulting from the announcement or completion of the
proposed transaction, (iv) the outcome of any legal proceedings
that may be instituted against the parties and others related to
the potential transaction between NantKwest and ImmunityBio, (v)
possible disruptions from the proposed transaction that could harm
NantKwest’s or ImmunityBio’s respective business, including current
plans and operations, (vi) unexpected costs, charges or expenses
resulting from the proposed transaction, (vii) uncertainty of the
expected financial performance of the combined company following
completion of the proposed transaction, including the possibility
that the expected synergies and value creation from the proposed
transaction will not be realized or will not be realized within the
expected time period, (viii) the ability of each of NantKwest or
ImmunityBio to continue its planned preclinical and clinical
development of its respective development programs, and the timing
and success of any such continued preclinical and clinical
development and planned regulatory submissions, (ix) inability to
retain and hire key personnel, and (x) the unknown future impact of
the COVID-19 pandemic delay on certain clinical trial milestones
and/or NantKwest’s or ImmunityBio’s operations or operating
expenses. More details about these and other risks that may impact
NantKwest’s business are described under the heading “Risk Factors”
in NantKwest’s most recent Quarterly Report on Form 10-Q and Annual
Report on Form 10-K filed with the U.S. Securities and Exchange
Commission (“SEC”) and in subsequent filings made by NantKwest with
the SEC, which are available on the SEC’s website at www.sec.gov.
NantKwest and ImmunityBio caution you not to place undue reliance
on any forward-looking statements, which speak only as of the date
hereof. NantKwest and ImmunityBio do not undertake any duty to
update any forward-looking statement or other information in this
communication, except to the extent required by law. No
representation is made as to the safety or effectiveness of these
product candidates for the therapeutic use for which such product
candidates are being studied.
Certain information contained in this presentation relates to or
is based on studies, publications, surveys and other data obtained
from third-party sources and NantKwest’s and ImmunityBio’s own
internal estimates and research. While NantKwest and ImmunityBio
believe these third-party sources to be reliable as of the date of
this communication, it has not independently verified, and makes no
representation as to the adequacy, fairness, accuracy or
completeness of, any information obtained from third-party sources.
In addition, all of the market data included in this communication
involves a number of assumptions and limitations, and there can be
no guarantee as to the accuracy or reliability of such assumptions.
Finally, while NantKwest and ImmunityBio each believes its own
internal research is reliable, such research has not verified by
any independent source.
No Offer or Solicitation
This presentation is not intended to and does not constitute an
offer to sell or the solicitation of an offer to buy, sell or
solicit any securities or any proxy, vote or approval in any
jurisdiction pursuant to or in connection with the proposed
transaction or otherwise, nor shall there be any sale of securities
in any jurisdiction in which such offer, solicitation or sale would
be unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offer of securities
shall be deemed to be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act.
Additional Information and Where to Find It
In connection with the proposed transaction, NantKwest intends
to file a registration statement on Form S-4 with the SEC, which
will include a prospectus and joint proxy / solicitation statement
of NantKwest and ImmunityBio (the “solicitation
statement/prospectus”). NantKwest may also file other documents
regarding the proposed transaction with the SEC. This communication
does not constitute an offer to sell or the solicitation of an
offer to buy any securities or a solicitation of any vote or
approval. This communication is not intended to be, and is not, a
substitute for such filings or for any other document that
NantKwest may file with the SEC in connection with the proposed
transaction. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION,
INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE
ENTIRE REGISTRATION STATEMENT AND SOLICITATION STATEMENT /
PROSPECTUS, WHEN THEY BECOME AVAILABLE, AND ANY OTHER RELEVANT
DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR
SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTION. Investors and security holders will be able to obtain
free copies of the registration statement and solicitation
statement/prospectus and other documents filed with the SEC by
NantKwest through the website maintained by the SEC at www.sec.gov.
In addition, investors and security holders will be able to obtain
free copies of the prospectus and other documents filed with the
SEC on NantKwest’s website at www.ir.nantkwest.com.
Participants in the Solicitation
NantKwest and certain of its respective directors and executive
officers may be deemed to be participants in the solicitation of
proxies from stockholders of NantKwest in connection with the
proposed transaction under the rules of the SEC. Investors may
obtain information regarding the names, affiliations and interests
of directors and executive officers of NantKwest in NantKwest’s
proxy statement for its 2020 annual meeting of stockholders, which
was filed with the SEC on April 24, 2020, as well as its other
filings with the SEC. Other information regarding the participants
in the proxy solicitation and a description of their direct and
indirect interests, by security holdings or otherwise, will be
included in the registration statement, solicitation statement /
prospectus and other relevant materials to be filed with the SEC by
NantKwest regarding the proposed transaction (if and when they
become available). You may obtain free copies of these documents at
the SEC’s website at www.sec.gov. Copies of documents filed with
the SEC will also be available free of charge from NantKwest using
the sources indicated above.
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version on businesswire.com: https://www.businesswire.com/news/home/20210113005928/en/
Investors Sarah Singleton 844-696-5235, Option 5
Media Andrew Siegel / Greg Klassen Joele Frank, Wilkinson
Brimmer Katcher 212-355-4449
Amy Jobe LifeSci Advisors 315-879-8192
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