- The novel immunotherapy NANT Cancer Vaccine (NCV) developed at
ImmunityBio based on the concept of founder Patrick Soon-Shiong,
M.D. has been studied in both Phase 1 and 2 trials in tumor types
including pancreatic, breast, colorectal, and head and neck
cancers.
- The NCV is an innovative approach combining delivery of
low-dose chemotherapy with ImmunityBio’s adenoviral and yeast-based
cancer antigen vaccines, proprietary natural killer cell platform
and the IL-15 superagonist N-803 (Anktiva™).
- In clinical trials, the NCV approach has been shown to induce
complete remission across multiple tumor types in patients who
previously progressed on standard-of care therapy, with an adverse
effect profile that is favorable compared to high-dose
chemotherapy.
- With this issued patent, ImmunityBio’s intellectual property
portfolio includes more than 1,100 issued and pending patents
worldwide for its immunotherapy technologies, with patent life
extending to 2035 and beyond.
ImmunityBio, Inc., a publicly traded immunotherapy company,
announced today that it has been granted a patent by the U.S.
Patent and Trademark Office for its proprietary NANT Cancer Vaccine
(U.S. Patent 11,071,774). This novel investigational treatment for
cancer is designed to bolster a patient’s own immune response to
cancerous cells, augment that response with additional natural
killer and T-cell therapies to overcome the cancer’s resistance,
and induce long-term T-cell memory to induce remission across
multiple tumor types.
The NCV has been in clinical testing since 2017 and has its
foundation in earlier work that led to the development of
Abraxane®, an albumin nanoparticle that enables the delivery of
paclitaxel to the tumor microenvironment. The basis of the
orchestrated, multi-modal NCV approach is delivery of chemotherapy
agents in a ‘metronomic’ fashion—low doses spread over time—to
expose the tumor to immune system recognition by release of
tumor-specific antigens. The tumor antigens are then targeted by
antigen-specific T-cells activated via ImmunityBio’s adenoviral-
and yeast-based vaccine vectors. T cell activation can then be
enhanced further by infusion of the company’s proprietary,
off-the-shelf, natural killer cell platform and its IL-15
superagonist N-803 (Anktiva).
To study the safety and early efficacy signals across multiple
tumor types, the company has launched a series of Quantitative
Lifelong Trials (QUILT). To date, the NANT Cancer Vaccine has been
studied in more than 100 patients across multiple tumor types,
including pancreatic, breast, colorectal, and head and neck
cancers. Among these studies is QUILT 88, a Phase 2 trial studying
the NCV in metastatic pancreatic cancer patients. Enrollment of
Cohort C, patients who have previously failed two lines of
standard-of-care therapy, is expected to be completed in the third
quarter of 2021 and an early readout of survival data is expected
in the first quarter of 2022.
“We are excited to be developing this orchestrated approach to
activate as many elements of the immune system that we can and
overcome cancer’s ability to evade the immune system. Our
hypothesis is that by revealing tumor antigens to the immune
system, we activate tumor-specific T cells and targeted natural
killer cells to eradicate tumors by what is known as immunogenic
cell death,” said Patrick Soon-Shiong, M.D., Founder and Executive
Chairman of ImmunityBio. “The issuance of the NANT Cancer Vaccine
patent is recognition of this innovative approach to therapy that
not only potentially provides long-term immune system protection
from cancer, it does so with a reduced risk of the toxicity risk
that comes with using high-dose chemotherapy and radiation. This
closely aligns with the FDA’s recent ‘Project Optimist’ guidelines
for exploring lower doses of therapeutic agents.”
ImmunityBio’s intellectual property portfolio includes more than
1,100 issued and pending patents worldwide across multiple
categories including biologics, vaccine vectors, natural killer
cells, and GMP devices. Patents for key areas such as N-803
(Anktiva), adenovirus vaccine vectors, yeast vaccine vectors, NK-92
cells and therapies extend to 2035 and beyond.
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
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 patent protection, the potential
of the NCV and the timing of availability and release of data from
the Company’s clinical trials. 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 ImmunityBio’s
clinical trials that it announces or publishes 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) 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 obtain, maintain, protect
and enforce patent protection and other proprietary rights for its
product candidates and technologies and (vii) 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210727005426/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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