- The “neoepitope” identification pipeline facilitates discovery
of immunotherapy targets unique to individual cancer patients as a
personalized and precision medicine approach to treatment
- The neoepitopes identified can be leveraged to improve outcomes
with adoptive cell transfer therapy and personalized vaccines
- Adenovirus and Yeast vaccine platforms in Phase1/2 clinical
trials to drive immunity to tumor-associated antigens and
neoantigens across multiple solid tumor types
ImmunityBio, Inc. (NASDAQ: IBRX), a publicly traded
immunotherapy company , and privately-held NantOmics today
announced publication of a stepwise approach or “pipeline” for
identification and validation of neoepitope and neoepitope-reactive
T cells from individual patients. The identification of
neoepitopes—short peptide sequences that are mutated in tumors and
are capable of generating an immune response—provides critical
support in the successful development of next-generation
immunotherapies delivered by ImmunityBio’s Adeno- and yeast-based
platforms. The pipeline is described in “Identification and
validation of expressed HLA-binding breast cancer neoepitopes for
potential use in individualized cancer therapy,” which recently
published in the Journal for Immunotherapy of Cancer.
The pipeline leverages the bioinformatics capabilities of
NantOmics and ImmunityBio to predict neoepitopes based on genomic
and expression analyses that have a high likelihood of generating a
tumor-fighting immune response and the generation of
neoepitope-specific CD4+ and CD8+ T cells when delivered using the
Adeno and yeast vaccine platforms. These predicted neoepitopes once
identified are synthesized as short peptides, and run through a
series of studies to confirm their potential utility in the cancer
vaccine platforms. The pipeline was developed in conjunction with
physicians and scientists at Friedrich Alexander University in
Germany and the National Cancer Institute (NCI) in the U.S.
In clinical use, this neoepitope discovery system supports the
targeted delivery of antigens with ImmunityBio’s second-generation
Adeno platform. This platform, which has shown promising results in
Phase 1 and 2 trials, activates CD4+ and CD8+ T cells after
delivery of tumor-associated antigens in patients with advanced
solid tumors and colon cancer. In preclinical studies conducted in
collaboration with the NCI, accurate prediction of neoepitopes,
delivered via the adenovirus platform, resulted in complete
response in colon cancer when combined with ImmunityBio’s IL-15
superagonist Anktiva and other immune-based therapies. That study
highlights the potential for neoepitope identification to inform
highly effective anti-tumor therapy.
“The future of immunotherapy is in a personalized approach,”
said Dr. Patrick Soon-Shiong, Founder and Executive Chairman of
ImmunityBio. “By tailoring therapies to the individual biology of
each patient’s cancer, we greatly increase the likelihood of
successful treatment using our ever-increasing arsenal of
immune-based therapies.”
“Validation of the neoepitope identification pipeline in actual
patients from the TILGen study was an important aspect of the
proposed method,” said Dr. Peter Fasching, who with Dr. Anita
Kremer, was senior author on the manuscript. “We were able to
isolate the specific immune cells that recognized the predicted
neoepitopes. Those immune cells aimed at the cancer cells’
neoepitopes are very important because they could potentially kill
a tumor. Clinically, the predicted and confirmed neoepitopes could
be targeted by vaccines or adoptive cell transfer therapies and
improve patient outcomes.”
Neoepitopes can be unique for each patient and when the pipeline
is applied, the analyses for identification of these neoepitopes
would be performed using tumor and other tissues collected from
individual patients.
This method for identifying tumor-specific immunogenic targets
for individualized treatment can be used as part of a program
including other immune and cell-based therapies available through
ImmunityBio, including CAR T-cell therapies and vaccines. Efficacy
of these therapies could be further enhanced by combination with an
immune enhancer such as ImmunityBio’s Anktiva® or Natural Killer
(NK) cells.
About the Neoepitope Identification Pipeline
- The bioinformatics methodology, well-established at NantOmics,
readily and accurately predicts neoantigens;
- Practical cell-based assays of synthesized neoepitope peptides
refines candidates to those most likely to induce an immune
response;
- and Tissues and cells routinely collected from individual
cancer patients can be used to confirm and further narrow
neoepitope candidates.
The neoepitope identification and validation pipeline is
feasible, practical and accurate, as this first report suggests. It
is anticipated that it will be applied in future clinical studies
of immunotherapies to determine the merits of this personalized
approach to precision medicine for cancer.
About ImmunityBio ImmunityBio is a leading
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.”
ImmunityBio has a comprehensive immunotherapy pipeline with more
than 40 clinical trials (company sponsored or investigator
initiated)—of which 25 are at Phase II and III stage of
development—across 19 indications in solid and liquid cancers and
infectious diseases. Currently 17 first-in-human immunotherapy
agents are in clinical testing and, to date, over 1,800 patients
have been studied with our antibody cytokine fusion proteins,
albumin chemo immunomodulators, Adeno and yeast vaccines and our
off-the-shelf natural killer cell products. 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’s platforms are based on the foundation of four
separate modalities: Antibody cytokine fusion proteins, synthetic
immunomodulators, second-generation human adenovirus (hAd5) and
yeast vaccine technologies, and state-of-the-art, off-the-shelf
natural killer cells, including autologous and allogenic
cytokine-enhanced memory NK cells. ImmunityBio is currently
developing a dual construct COVID-19 vaccine candidate using its
hAd5 platform.
ImmunityBio is a leading producer of cryopreserved and clinical
dose forms of off-the-shelf natural killer (NK) cell therapies. The
company has established GMP manufacturing capacity at scale with
cutting-edge cell manufacturing expertise and ready-to-scale
facilities, as well as extensive and seasoned R&D, clinical
trial, and regulatory operations and development teams. For more
information, please visit: www.immunitybio.com
About NantOmics NantOmics, a member of the NantWorks
ecosystem of companies, is a leader in molecular testing and the
first company to employ an integrated panomic approach to inform
personalized treatment options for patients with cancer. Combining
DNA sequencing, RNA sequencing, and quantitative proteomics,
NantOmics offers extensive testing capabilities that provide a
comprehensive molecular profile of a patient’s cancer. Our
proprietary analytical platform delivers molecular diagnostic
capabilities that provide actionable intelligence and molecularly
driven decision support for cancer patients and their providers at
the point of care. For more information, please visit:
www.nantomics.com.
Forward Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. 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”, “could”,
“estimates,” “expects,” “intends,” “may,” “plans,” “potential”,
“predicts”, “projects,” “seeks,” “should,” “will,” and variations
of such words or similar expressions. Statements of past
performance, efforts, or results of our 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 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 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, (ii) inability to retain and hire key
personnel, (iii) uncertainty of the expected financial performance
and successful integration of the combined company following
completion of the recent merger of ImmunityBio with NantCell (the
“Merger”), including the possibility that the expected synergies
and value creation from the Merger will not be realized or will not
be realized within the expected time period, (iv) whether interim,
initial, “top-line” and preliminary data from our clinical trials
that we announce or publish from time to time may change as more
patient data become available and are subject to audit and
verification procedures that could result in material changes in
the final data, (v) our ability to obtain additional financing to
fund our operations and complete the development and
commercialization of our various product candidates, and (vi) the
unknown future impact of the COVID-19 pandemic delay on certain
clinical trials or their milestones and/or ImmunityBio’s operations
or operating expenses. 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 8-K filed with the
U.S. Securities and Exchange Commission (“SEC”) on March 10, 2021,
Form 10-Q filed with the SEC on May 14, 2021 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/20210628005267/en/
Investors Sarah Singleton ImmunityBio, Inc. 844-696-5235,
Option 5 Media Katie Dodge Salutem 978-360-3151
Katie.Dodge@salutemcomms.com
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