- Application covers 30 countries in the European Union
- Submission is based on the ongoing QUILT 3.032 study in which
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% (71/100)
complete response (CR) rate
- In these responders, the range of duration is 54 months and
ongoing, exceeding all duration of response in approved products in
this indication
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy
company, today announced the European Medicines Agency (EMA) has
accepted for review and begun assessing the marketing authorization
application (MAA) for ANKTIVA (nogapendekin alfa inbakicept-pmln)
in combination with Bacillus Calmette-Guérin (BCG) for the
treatment of patients with BCG-unresponsive non-muscle invasive
bladder cancer (NMIBC) with carcinoma in situ (CIS), with or
without papillary tumors. The EMA covers 27 countries in the
European Union (EU), as well as Iceland, Norway and
Liechtenstein.
“We are encouraged by the speed in which the EMA accepted our
marketing authorization application and determined it would begin
its assessment of our innovative treatment for this serious
condition, just nine months after it was first approved by the FDA
for use in the United States,” said Dr. Patrick Soon-Shiong,
Founder, Executive Chairman and Global Chief Scientific and Medical
Officer of ImmunityBio. “Along with our submission to the United
Kingdom’s Medicines and Healthcare products Regulatory Agency
(MHRA), this action by the EMA is strong evidence of the momentum
for putting ANKTIVA+BCG into the hands of physicians who are
treating patients with NMIBC.”
The EMA submission is based on the ongoing QUILT 3.032 study in
which the complete response rate for the 100 evaluable patients in
Cohort A as of the July 15, 2024 cut-off was 71%. In these
responders, the range of duration of response is 0.03 to 54 months
and is ongoing. These prolonged duration of complete response
results beyond four years with ANKTIVA and BCG exceed the benchmark
of 18 months for the magnitude of meaningful clinical results
suggested by a panel of experts at the International Bladder Cancer
Group.
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.
ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive
non-muscle invasive bladder cancer CIS with or without papillary
tumors. For more information, visit Anktiva.com.
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 the anticipated timing of the
EMA’s review of ImmunityBio’s MAA and ultimate decision regarding
whether to approve ANKTIVA for the treatment of patients with
BCG-unresponsive NMIBC CIS in the countries under its jurisdiction,
additional 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 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,” “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 the EMA regulatory review process, potential actions
required in connection with the same, and whether or not the EMA
will ultimately approve ImmunityBio’s MAA that has been accepted
for review, (ii) risks and uncertainties regarding commercial
launch execution, success and timing, (iii) risks and uncertainties
related to the regulatory submission, filing and review process and
the timing thereof, (iv) the ability of ImmunityBio to fund its
ongoing and anticipated clinical trials, (v) whether clinical
trials will result in registrational pathways, (vi) whether
clinical trial data will be accepted by regulatory agencies, (vii)
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, (viii) potential delays in
product availability and regulatory approvals, (ix) ImmunityBio’s
ability to retain and hire key personnel, (x) ImmunityBio’s ability
to obtain additional financing to fund its operations and complete
the development and commercialization of its various product
candidates, (xi) potential product shortages or manufacturing
disruptions that may impact the availability and timing of product,
(xii) ImmunityBio’s ability to successfully commercialize its
approved product and product candidates, (xiii) ImmunityBio’s
ability to scale its manufacturing and commercial supply operations
for its approved product and future approved products, and (xiv)
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.
Indication and Important Safety Information
INDICATION AND USAGE: ANKTIVA is an interleukin-15
(IL-15) receptor agonist indicated with Bacillus Calmette-Guérin
(BCG) for the treatment of adult patients with BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ
(CIS) with or without papillary tumors.
WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder
Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the
development of muscle invasive or metastatic bladder cancer, which
can be lethal. If patient with CIS do not have a complete response
to treatment after a second induction course of ANKTIVA with BCG,
reconsider cystectomy.
DOSAGE AND ADMINISTRATION: For lntravesical Use Only. Do
not administer by subcutaneous or intravenous routes. Instill
intravesically only after dilution. Total time from vial puncture
to the completion of the intravesical instillation should not
exceed 2 hours.
USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal
harm. Advise females of reproductive potential of the potential
risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common (≥15%) adverse
reactions, including laboratory test abnormalities, are increased
creatinine, dysuria, hematuria, urinary frequency, micturition
urgency, urinary tract infection, increased potassium,
musculoskeletal pain, chills and pyrexia.
For more information about ANKTIVA, please see the Full
Prescribing Information at www.anktiva.com.
You are encouraged to report negative side effects of
prescription drugs to FDA.
Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also
contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250127517387/en/
Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc.
+1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com
Media Sarah Singleton ImmunityBio, Inc. +1 415-290-8045
Sarah.Singleton@ImmunityBio.com
ImmunityBio (NASDAQ:IBRX)
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