- All participants in the Phase 1 pilot study experienced a
marked decrease in the burden of infection, and the procedures were
found to be safe and well tolerated
- N-803 is being studied in three other HIV cure-related clinical
trials
ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy
company, today announced data from a Phase 1 pilot study showed
N-803 combined with natural killer cells could have the potential
to reduce viral load in people living with HIV.
Published in The Journal of Infectious Diseases, researchers at
the University of Minnesota Medical School gave six HIV-positive
individuals infusions of healthy NK cells from close relatives,
along with N-803 to boost NK cell activity. All participants in
this Phase 1 study experienced significant reduction in infection
levels following treatment with N-803. The approach was well
tolerated with no unexpected adverse events.
Tim Schacker, MD, senior author of this paper, and colleagues at
the University of Minnesota Medical School are planning a follow-on
study in additional participants to further investigate these
immunotherapies in HIV infected individuals.
HIV affects tens of millions globally and currently has no known
cure. HIV can disable NK cells—a frontline defense against viral
infections—making it difficult to clear the infection. One current
strategy for curing HIV is known as the "kick and kill" approach.
N-803 is under evaluation using this strategy, given the molecule’s
ability to activate viral transcription in CD4+ T cells ("kick")
and boost CD8+ and NK cells, crucial for identifying and
eliminating infected cells ("kill"), directing them to viral
reservoirs.
"Antiretroviral therapies have had a profound impact on society,
making it possible for those living with HIV to live longer lives
with better outcomes. However, these therapies are not a cure, and
still place a significant burden on people living with the HIV
virus and the healthcare system,” said Patrick Soon-Shiong, M.D.,
Chairman and Global Chief Scientific and Medical Officer at
ImmunityBio. “These data preliminarily appear to validate what we
know about the benefit of enhancing NK cell function and the
potential utility of N-803 in infectious diseases.”
In addition to this study, three other clinical trials are
underway involving N-803 in HIV Cure-related strategies. Two Phase
1 clinical trials are investigating N-803 in combination with bNAbs
in HIV-infected individuals (ACTG A5386, NCT04340596: and
NCT05245292 at the Rockefeller University) and a Phase 2 study is
also underway to investigate the effect of combining N-803 with ART
during acute HIV infection, sponsored by the Thai Red Cross and the
U.S. Military HIV Research Program. To learn more about these
studies, please visit our website.
ImmunityBio’s IL-15 superagonist N-803 (also called Anktiva®
and nogapendekin alfa inbakicept)
The cytokine interleukin-15 (IL-15) plays a crucial role in the
immune system by affecting the development, maintenance, and
function of the natural killer (NK) and T cells. N-803 is a novel
investigational IL-15 superagonist complex consisting of an IL-15
mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion
protein. Its proposed mechanism of action is direct specific
stimulation of CD8+ T cells and NK cells through beta gamma T-cell
receptor binding with generation of memory T-cells while avoiding
T-reg stimulation. N-803 is designed to have improved
pharmacokinetic properties, longer persistence in lymphoid tissues
and enhanced anti-tumor activity compared to native, non-complexed
IL-15 in vivo.
N-803 is currently being evaluated in adult patients in two
clinical NMIBC trials. QUILT-2.005 is investigating use of N-803 in
combination with BCG for patients with BCG-naïve NMIBC; QUILT-3.032
is studying N-803 in combination with BCG in patients with
BCG-unresponsive NMIBC CIS and Papillary Disease.
N-803 is investigational. Safety and efficacy 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 clinical trial data, results and
plans, 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 follow-on study referenced, (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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240305877538/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@Salutemcomms.com
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