- The first 20 participants have been enrolled in an important
national, multicenter trial to test whether ImmunityBio’s Nant
Cancer Vaccine (NCV) comprising a tri-valent Adenovirus (Tri-Ad5)
in combination with the company’s IL-15 superagonist N-803 could
potentially prevent colon and other cancers in individuals with
Lynch syndrome. With enrollment of the first two open-label phases
of the trial completed, the study will now proceed to the
randomized controlled phase.
- When fully enrolled, the completed randomized Phase 2 study
will include up to 186 individuals. In the randomized controlled
phase 138 participants will be randomized to ImmunityBio’s NCV or
placebo.
- Lynch syndrome is associated with a genetic mutation present in
an estimated one million Americans1 who are more likely to be
diagnosed with cancer at a younger age and are at increased risk of
developing multiple types of cancers during their lifetime.
- This NCV study is the first to evaluate vaccines, delivered by
an adenovirus vaccine platform, combined with an immune-enhancer,
N-803, to target cancer-specific proteins and activate natural
killer (NK) and T cells to prevent cancer.
ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy
company, today announced that enrollment and initial follow-up has
been completed for the safety portions of a clinical trial that is
studying ImmunityBio’s investigational cancer vaccine of a
tri-valent combination of antigens delivered by a second-generation
Adenovirus vector (Tri-Ad5 CEA/MUC1/brachyury) together with its
IL-15 superagonist N-803 for participants with Lynch syndrome. The
study, sponsored by the National Cancer Institute, part of the
National Institutes of Health, will include up to 186 participants
when fully enrolled and is now open to the randomized controlled
portion of the trial.
Each of the three vaccines in Tri-Ad5 targets different proteins
associated with precancer and cancer cells. The vaccine combination
is studying whether activation of dendritic cells and training the
immune system to recognize those proteins will destroy the
precancer cells before the cancer occurs. The IL-15 superagonist
N-803 is designed to enhance the effects of the vaccines by
increasing proliferation and activation of natural killer (NK) and
T cells, thereby increasing the potential for cancer prevention in
study participants.
“We are pleased to be selected to participate in this important
and innovative cancer prevention study, one that could provide
insights into how the immune system could be harnessed to prevent
cancer in individuals with hereditary risk,” said Patrick
Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific
and Medical Officer at ImmunityBio. “With an estimated 5 to 10
percent of cancers inherited, understanding mechanisms that might
prevent or delay their onset could potentially change the prospects
for tens of thousands of people annually.”
Lynch syndrome (also called hereditary non-polyposis colorectal
cancer or HNPCC) is one of the most common hereditary cancer
syndromes occurring in 1 in every 300 Americans.2 Not only can
people with Lynch syndrome develop colorectal cancer 20 years
before the average age of diagnosis for this cancer, they are also
at an increased risk of developing multiple types of other cancers,
including endometrial, stomach, ovarian, pancreas, ureter and renal
pelvis, biliary tract, brain, and small intestinal cancers.
Colorectal cancer is the second-deadliest cancer type in the U.S.,
and approximately 3% to 5% of the 153,000 cases of colorectal
cancer annually are thought to be due to Lynch Syndrome, as are 2%
to 3% of all cases of endometrial cancer.3
“We are encouraged by how rapidly this study has been able to
enroll participants,” said Asad Umar, D.V.M., Ph.D., a senior
advisor to the Director for Translational Research in NCI’s
Division of Cancer Prevention (DCP) and a scientific lead for the
trial. “It is a strong indication of an unmet need and of the
willingness of participants to help science make new discoveries in
the area of cancer prevention.”
To learn more about this study, please visit
https://clinicaltrials.gov/ct2/show/NCT05419011.
For patients interested in enrolling in this study, please
contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237)
(TTY: 1-800-332-8615) and/or the website: https://trials.cancer.gov
and/or NCIMO_referrals@mail.nih.gov.
ImmunityBio’s Tri-Ad5 Vaccines and N-803 are investigational.
Safety and efficacy of these investigational agents have not been
established by any Health Authority, including the FDA.
About ImmunityBio’s Tri-Ad5 Vaccines
ImmunityBio’s Tri-Ad5 vaccines target three tumor-associated
antigens: brachyury, carcinoembryonic antigen (CEA), and mucin-1
(MUC1). Pre-clinical studies have demonstrated Tri-Ad5 vaccines
elicit cytotoxic T cell-mediated tumor cell death and the
establishment of memory T cells, and thus may provide protection
against the growth and metastasis of cancer. Tri-Ad5 vaccines
utilize a second-generation replication-defective human adenovirus
serotype 5 (Ad5) vector with viral genes deleted to allow for
production of the antigen and a vigorous immune response, without
generating a host response to the vector and with the ability to
overcome previous adenovirus immunity in cancer patients. Notably,
in a phase 1 NCI trial, Tri-Ad5 generated antigen-specific T cells
to MUC1, CEA, and/or brachyury in all 10 patients with no evidence
of antigenic competition. The safety of multiple ImmunityBio
product candidates utilizing the Ad5 technology has been
demonstrated in phase 1 and 2 clinical trials for cancers across
several tumor types.
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
1-3. American Society of Clinical Oncology (ASCO) Cancer.net
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 clinical trial protocols, phases
and patient enrollment, information regarding potential patient
population, potential benefit 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 including without
limitation the Company’s BLA resubmission following receipt of the
complete response letter (CRL) from the FDA and the ability of
ImmunityBio and its third party contract manufacturing
organizations to adequately address the issues raised in the CRL,
(ii) whether or not the clinical trial referenced in this release
will continue to progress as anticipated, including without
limitation the ability to enroll additional patients, (iii) the
ability of ImmunityBio to continue its planned preclinical and
clinical development of its development programs through itself
and/or its investigators, 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 November 9, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240221666790/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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