- Findings from NCI-led study suggest that Memory
Cytokine-Enriched Natural Killer cells (M-ceNK) may provide benefit
to patients with small cell lung cancer and patients with other
types of neuroendocrine tumors
- M-ceNK may provide an additional line of therapy in other cases
of immunologically cold tumors lacking MHC expression after a
checkpoint blockade therapy
- The first-in-class M-ceNK cells use the patient’s own NK cells,
which have been enriched with cytokines including ImmunityBio’s
IL-15 superagonist N-803, to recognize and kill cancer targets with
longer persistence
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy
company, today announced new data showing that the company’s Memory
Cytokine-Enriched Natural Killer cells (M-ceNK) may provide benefit
to patients with small cell lung cancer and patients with other
types of neuroendocrine tumors. Findings from the study titled
“Characterization of the anti-tumor activity of memory cytokine
enriched NK cells (M-ceNK) against tumors with neuroendocrine
features” were presented by Kristen Fousek, Ph.D., Research Fellow
with the Center for Immuno-Oncology of the National Institutes of
Health’s National Cancer Institute (NCI) in a poster session
(Abstract #358) at the annual meeting of the Society for
Immunotherapy of Cancer (SITC) in San Diego, November 4, 2023.
Small cell lung cancer (SCLC) is an aggressive neuroendocrine
(NE) carcinoma and has few treatment options. Although immune
checkpoint blockade (ICB) is approved in combination with
chemotherapy in extensive stage disease, only a subset of patients
experience an improvement in overall survival. Studies suggest that
a lack of response to ICB is partially attributable to low
expression of MHC-class I. Recently, an NCI research group (Fousek
et al., 2023) reported that the lack of MHC-class I can be
leveraged to enable targeting by NK cells stimulated with
ImmunityBio’s IL-15 cytokine superagonist N-803. These findings led
researchers to hypothesize that M-ceNK cells may be effective in
targeting SCLC.
In the new study, the killing capacity of M-ceNK cells was
assessed in four SCLC cell lines representing the major molecular
subtypes. M-ceNK cells, generated from cells from several healthy
donors, were found to express high levels of activating receptors
and low levels of inhibitory receptors, as well as elevated
IFN-γ and granzyme B production – all of which are
important for anti-tumor activity. The M-ceNK cells were highly
cytotoxic against all types of SCLC models, as well as against
prostate neuroendocrine cancer. Overall, the study revealed the
potential for M-ceNK-based approaches for the treatment of NE
tumors, including all molecular subtypes of SCLC and supports
future studies in other tumor types that are unresponsive to
ICB.
“These results are further evidence of the potential of M-ceNK
therapy as a new immunotherapy approach for treating cancers that
do not respond to immune checkpoint blockade, the current standard
of care,” said Patrick Soon-Shiong, M.D., Executive Chairman and
Global Chief Scientific and Medical Officer at ImmunityBio. “We are
encouraged by the data coming out of this study and we look forward
to assessing the potential for M-ceNK therapy in other tumor
types.”
About M-ceNK
Memory-like cytokine-enhanced natural killer (M-ceNK cells are a
unique set of white blood cells (lymphocytes) that are first
collected from individual patients (autologous cells) then
differentiated into the specialized NK cells with enhanced
anti-cancer function by brief pre-activation with interleukin-12
(IL-12), IL-15, and IL-18. These cells are characterized by their
unique cell-surface marker profile and enhanced responses to
cytokine re-stimulation that include increased IFN-γ production and
cytotoxicity against leukemic cell lines. They are called
‘memory-like’ due to their highly desirable feature of
immune-memory, reflected by their persistence and pronounced
anti-cancer activity observed in clinical studies for weeks to
months in duration (reviewed in Berrien-Elliott et al., 2023).
Through the application of ImmunityBio’s proprietary GMP-in-a-Box
bioreactors and cytokines, the company has not only developed a new
method that yields multiple doses from a single lymphocyte
collection, but also a method to generate M-ceNK cells from cord
blood (allogeneic) so that collection from the patient may not be
necessary. The company has also found that the efficacy of M-ceNK
cells can be further amplified by the IL-15 superagonist N-803.
Because the generated M-ceNK cells are stored using our optimized
cryopreservation protocol, they have maximum shelf-life and potency
upon recovery, a necessity for any off-the-shelf product.
The safety and preliminary efficacy of M-ceNK cells in locally
advanced or metastatic solid tumors are currently being assessed in
the Phase 1 clinical trial, QUILT-3.076, which is actively
enrolling patients at this time (NCT04898543).
M-ceNK cells and N-803 are investigational. Safety and efficacy
of these investigational agents have not been established by any
Health Authority or Agency, including the FDA.
About ImmunityBio
ImmunityBio is a vertically-integrated, clinical-stage
biotechnology company developing next-generation therapies and
vaccines that bolster the natural immune system to defeat cancers
and infectious diseases. The company’s range of immunotherapy and
cell therapy platforms, alone and together, act to drive and
sustain an immune response with the goal of creating durable and
safe protection against disease. We are applying our science and
platforms to treating cancers, including the development of
potential cancer vaccines, as well as developing immunotherapies
and cell therapies that we believe sharply reduce or eliminate the
need for standard high-dose chemotherapy. These platforms and their
associated product candidates are designed to be more effective,
accessible, and easily administered than current standards of care
in oncology and infectious diseases.
For more information, please visit: www.immunitybio.com
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, such as statements regarding the development of therapeutics
for SCLC and other indications, study results and potential
implications therefrom, potential benefits to patients, potential
additional studies and trials, methods, regulatory pathways and
ImmunityBio’s investigational agents as compared to existing
treatment options, among others. Statements in this press release
that are not statements of historical fact are considered
forward-looking statements, which are usually identified by the use
of words such as “anticipates,” “believes,” “continues,” “goal,”
“could,” “estimates,” “scheduled,” “expects,” “intends,” “may,”
“plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,”
“should,” “will,” “strategy,” and variations of such words or
similar expressions. Statements of past performance, efforts, or
results of our preclinical and clinical trials, about which
inferences or assumptions may be made, can also be forward-looking
statements and are not indicative of future performance or results.
Forward-looking statements are neither forecasts, promises nor
guarantees, and are based on the current beliefs of ImmunityBio’s
management as well as assumptions made by and information currently
available to ImmunityBio. Such information may be limited or
incomplete, and ImmunityBio’s statements should not be read to
indicate that it has conducted a thorough inquiry into, or review
of, all potentially available relevant information. Such statements
reflect the current views of 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 ImmunityBio,
including, without limitation, (i) the risks and uncertainties
associated with the regulatory review process, (ii) the ability of
ImmunityBio and its third party contract manufacturing
organizations to adequately address the issues raised in the FDA’s
complete response letter, (iii) the ability of ImmunityBio to
continue its planned preclinical and clinical development of its
development programs, and the timing and success of any such
continued preclinical and clinical development and planned
regulatory submissions, (iv) ImmunityBio’s ability to retain and
hire key personnel, (v) ImmunityBio’s ability to obtain additional
financing to fund its operations and complete the development and
commercialization of its various product candidates, (vi)
ImmunityBio’s ability to successfully commercialize its product
candidates and uncertainties around regulatory reviews and
approvals, (vii) ImmunityBio’s ability to scale its manufacturing
and commercial supply operations for its product candidates and
future approved products, and (viii) ImmunityBio’s ability to
obtain, maintain, protect and enforce patent protection and other
proprietary rights for its product candidates and technologies.
More details about these and other risks that may impact
ImmunityBio’s business are described under the heading “Risk
Factors” in the Company’s Form 10-K filed with the U.S. Securities
and Exchange Commission (“SEC”) on March 1, 2023 and the Company’s
Form 10-Q filed with the SEC on August 8, 2023, and in subsequent
filings made by ImmunityBio with the SEC, which are available on
the SEC’s website at www.sec.gov. ImmunityBio cautions you not to
place undue reliance on any forward-looking statements, which speak
only as of the date hereof. ImmunityBio does not undertake any duty
to update any forward-looking statement or other information in
this press release, except to the extent required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20231107571659/en/
Investors Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc. +1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media Greg Tenor Salutem +1 717-919-6794
Gregory.Tenor@Salutem.com
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