ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy
company, today announced the recent publication of preclinical data
in the online issue of Science, First Release indicating that
combination therapy with N-803, an IL-15 superagonist, and broadly
neutralizing antibodies may potentially enable the immune system to
manage human immunodeficiency virus (HIV) without the need for
antiretroviral treatment.
In the preclinical non-human primate study, researchers led by
Dr. James Whitney, Ph.D. and funded by the National Institutes of
Health and the National Institute of Allergy and Infectious
Diseases (NIAID) demonstrated that using N-803, in combination with
broadly neutralizing antibodies (bNAbs), led to sustained viral
control after discontinuation of antiretroviral therapy (ART) in
ART-suppressed rhesus macaques infected with simian-human
immunodeficiency virus AD8 (SHIV-AD8). Treatment with N-803 and
bNAbs led to immune activation and transient viremia, but only
limited reductions in the SHIV reservoir. Upon ART discontinuation,
all animals experienced viral rebound, followed by long-term virus
control for up to 10 months in approximately 70% of those treated
with N-803 and bNAbs.
"The viral reservoir in people with HIV is established within
the first few days of infection and cannot be eliminated by the
body’s immune system or currently available treatments,
representing a significant obstacle in curing an established HIV
infection,” said James B. Whitney, M.D., study author and
researcher at the Center for Virology and Vaccine Research at Beth
Israel Deaconess Medical Center and Harvard Medical School. “When
combined with broadly neutralizing antibodies, N-803 has the
potential to provide viral control without significant reduction in
the viral reservoir, which further suggests that the complete
eradication of this reservoir may not be required to induce
sustained remission after discontinuing antiretroviral
therapy."
Following on from and directly attributable to these preclinical
results, two clinical trials were designed to investigate the
ability of N-803 and bNAbs to reduce viral loads in HIV-infected
individuals on antiretroviral therapy. These Phase 1 clinical
trials are investigating N-803 in combination with bNAbs in
HIV-infected individuals and will include an analytical treatment
interruption (ATI) to determine the effect of the immunotherapies
on post therapy viral loads. (ACTG A5386, NCT04340596: and
NCT05245292 at the Rockefeller University). The studies are
actively enrolling participants.
To learn more about ImmunityBio’s HIV research, 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 pre-clinical study results and
plans, information regarding 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 pre-clinical study referenced in this
release will continue to progress as anticipated, (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/20240306651162/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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