- High responder rate associated with a duration of response
ranging as long as 54 months in QUILT-3.032 with 100 patients
enrolled
- Updated data intended to be submitted as part of a European
Medicines Agency (EMA) Submission in Q4 2024
- Complete response data in 100 patients consistent with CR rate
of 71% reported for 82 patients published in NEJM
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy
company, today announced compelling new data from its ongoing QUILT
3.032 study. As of November 2024, 100 patients with Bacillus
Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder
cancer with carcinoma in situ (NMIBC CIS) have been treated with
ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with
BCG, achieving a 71% complete response (CR) rate. In these
responders, the range of durable response extended to 54 months.
This data update will be submitted to the European Medicines Agency
(EMA) in a Marketing Authorization Application (MAA) for ANKTIVA in
the European Union (EU), which is anticipated during Q4 2024.
This significant milestone underscores the potential of ANKTIVA
to provide durable responses in patients with limited treatment
options. The QUILT 3.032 study is a single-arm, multicenter trial
evaluating the safety and efficacy of ANKTIVA plus BCG in patients
with BCG-unresponsive NMIBC CIS. The observed 71% CR rate aligns
with previous findings reported in the New England Journal of
Medicine (NEJM Evidence, Chamie 2022) and reinforces the
therapeutic promise of this combination therapy.
“We are encouraged by the consistent complete response rates
observed in our expanded patient cohort,” said Patrick Soon-Shiong,
M.D., Executive Chairman and Global Chief Scientific and Medical
Officer of ImmunityBio. “These results highlight the potential of
ANKTIVA to transform the treatment landscape for patients with
BCG-unresponsive NMIBC CIS, offering hope for improved outcomes and
cystectomy avoidance, especially with the prolonged duration of
response now ranging as much as 54 months in this 100-patient
analysis. Duration of complete response is the key efficacy element
in driving cystectomy avoidance in this BCG-unresponsive
population. I am pleased that this updated ANKTIVA data confirms
that one of the highest durable responses is achieved when compared
to other approved products in this indication.”
The QUILT 3.032 study continues to monitor patients to assess
the durability of responses and overall survival outcomes.
ImmunityBio remains committed to advancing innovative
immunotherapies that harness the body's immune system to combat
cancer.
About ANKTIVA
The cytokine interleukin-15 (IL-15) plays a crucial role in the
immune system by affecting the development, maintenance, and
function of key immune cells—NK and CD8+ killer T cells—that are
involved in killing cancer cells. By activating NK cells, ANKTIVA
overcomes the tumor escape phase of clones resistant to T cells and
restores memory T cell activity with resultant prolonged duration
of complete response. ANKTIVA is a first-in-class IL-15 agonist
IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D)
fused with an IL-15 receptor alpha, which binds with high affinity
to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion
complex of ANKTIVA mimics the natural biological properties of the
membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic
cells and drives the activation and proliferation of NK cells with
the generation of memory killer T cells that have retained immune
memory against these tumor clones. The proliferation of the
trifecta of these immune killing cells and the activation of
trained immune memory results in immunogenic cell death, inducing a
state of equilibrium with durable complete responses. ANKTIVA has
improved pharmacokinetic properties, longer persistence in lymphoid
tissues, and enhanced anti-tumor activity compared to native,
non-complexed IL-15 in-vivo.
About ImmunityBio
ImmunityBio is a vertically-integrated 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. Designated an FDA Breakthrough Therapy, ANKTIVA is the
first FDA-approved immunotherapy for non-muscle invasive bladder
cancer CIS that activates natural killer cells, T cells, and memory
T cells for a long-duration response. The Company is applying its
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, visit ImmunityBio.com and connect with us on X
(Twitter), Facebook, LinkedIn, and Instagram.
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 anticipated regulatory
submissions and timing thereof, global expansion efforts, clinical
trial data and potential results to be drawn therefrom, the
development of therapeutics for cancer and infectious diseases,
potential benefits to patients, potential treatment outcomes for
patients, the described mechanism of action and results and
contributions therefrom, potential future uses and applications of
ANKTIVA and use in cancer vaccines and across multiple tumor types,
and ImmunityBio’s approved product and investigational agents as
compared to existing treatment options, among others. Statements in
this presentation 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,”
“is,” “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) risks and uncertainties
regarding commercial launch execution, success and timing, (ii)
risks and uncertainties related to the regulatory submission,
filing and review process and the timing thereof, (iii) the ability
of ImmunityBio to fund its ongoing and anticipated clinical trials,
(iv) whether clinical trials will result in registrational pathways
and the risks and uncertainties regarding the regulatory
submission, review and approval process, (v) whether clinical trial
data, including that reported herein, will be accepted by
regulatory agencies, (vi) 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, patient enrollment and planned regulatory submissions,
(vii) potential delays in product availability and regulatory
approvals, (viii) ImmunityBio’s ability to retain and hire key
personnel, (ix) ImmunityBio’s ability to obtain additional
financing to fund its operations and complete the development and
commercialization of its various product candidates, (x) potential
product shortages or manufacturing disruptions that may impact the
availability and timing of product, (xi) ImmunityBio’s ability to
successfully commercialize its approved product and product
candidates, (xii) ImmunityBio’s ability to scale its manufacturing
and commercial supply operations for its approved product and
future approved products, and (xiii) 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 19, 2024 and the Company’s
Form 10-Q filed with the SEC on November 12, 2024, 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/20241119975432/en/
Investors Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc. +1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media Sarah Singleton ImmunityBio +1
415-290-8045 Sarah.Singleton@ImmunityBio.com
ImmunityBio (NASDAQ:IBRX)
過去 株価チャート
から 11 2024 まで 12 2024
ImmunityBio (NASDAQ:IBRX)
過去 株価チャート
から 12 2023 まで 12 2024
