- BCG unresponsive non-muscle invasive bladder cancer (NMIBC) in
the papillary indication: Anticipated supplemental biologics
license application (BLA) submission in 2025
- Alternative source of BCG in partnership with Serum Institute
of India: Anticipated submission for market access as an
alternative source in Q1 2025
- Second- and third-line non-small cell lung cancer (NSCLC)
progressing on checkpoint inhibitors (QUILT-3.055): Anticipated BLA
submission in 2025 with ongoing randomized Phase 3 trial in NSCLC
patients who have failed checkpoint inhibitors
(ResQ201A-NSCLC)
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy
company, today announced significant progress in its ongoing
discussions with the U.S. Food and Drug Administration (FDA)
regarding three areas of its clinical development pipeline in
non-muscle invasive bladder cancer (NMIBC) and non-small cell lung
cancer (NSCLC).
NMIBC BCG Unresponsive Papillary Disease: ImmunityBio is
preparing to submit a supplemental Biologics License Application
(sBLA) in 2025 for its innovative treatment targeting Bacillus
Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder
cancer (NMIBC) in the papillary indication. As published in the
Chamie 2022 NEJM1 publication, the primary endpoint was met with a
disease-free rate of 55% at 12 months, 51% at 18 months, and 48% at
24 months. In addition, patients receiving ANKTIVA® + BCG achieved
a 93% avoidance of cystectomy with a median follow up of 20.7
months. This immunotherapy of rescuing BCG with ANKTIVA
(nogapendekin alfa inbakicept-pmln), now approved in the CIS
indication, represents a step towards providing therapeutic options
in patients with BCG unresponsive NMIBC in papillary disease who
currently have limited treatment choices and face radical total
cystectomy (removal of bladder). The addition of the papillary
indication could expand the potential patient population benefiting
from this therapy and may allow patients to avoid the high
morbidity and mortality associated with radical total
cystectomy.
Alternative Source of BCG: In collaboration with the
Serum Institute of India, ImmunityBio plans a regulatory submission
for an alternative source of BCG in the first quarter of 2025.
Serum Institute’s GMP capacity to manufacture large-scale volumes
of BCG, already tested for safety and efficacy in clinical trials
in Europe in subjects with NMIBC, aims to address the shortage of
BCG, ensuring a reliable supply for patients in need. This
initiative underscores ImmunityBio's commitment to addressing
critical supply issues and expanding the opportunity for patients
and physicians to have access to high quality and quantities of BCG
to initialize and maintain treatments for bladder cancer, subject
to regulatory approvals.
Second-Line and Third-Line NSCLC Patients Who Have Progressed
on Checkpoint Inhibitors: A Phase 2b study (QUILT-3.055)
included (N=86) NSCLC patients and demonstrated prolonged overall
survival when ANKTIVA was combined with the same checkpoint
inhibitors on which patients were progressing, validating the
rescue potential of ANKTIVA for T cells and checkpoint inhibitors.
Compared to the most frequently used chemotherapy docetaxel in this
setting with overall survival ranging from 7 to 10 months and
associated with high toxicities of this chemotherapeutic agent,
ANKTIVA plus a checkpoint inhibitor represents an immunotherapeutic
advance for this disease.
ImmunityBio plans to submit a Biologics License Application
(BLA) in 2025 for second- and third-line treatment of patients with
NSCLC, who are progressing on checkpoint inhibitors. As presented
at the IASLC 2024 World Conference on Lung Cancer by Dr. Wrangle2,
the QUILT-3.055 study (Phase 2b, N=86) has shown promising results
demonstrating a median overall survival for all patients at 14.1
months. In PD-L1 negative subjects, the median overall survival
extended to 15.8 months.
“The potential to improve outcomes for NSCLC patients who have
already relapsed on checkpoints is an unmet need. The combination
of administering ANKTIVA plus a checkpoint even after checkpoint
relapse/refractory represents a large potential for ANKTIVA to
rescue checkpoint failure and prolong overall survival without the
toxicities of chemotherapy,” said Dr. Patrick Soon-Shiong,
Executive Chairman and Global Chief Medical and Scientific Officer
of ImmunityBio. “This submission underscores ImmunityBio's
dedication to advancing cancer treatment and providing new hope for
patients battling this aggressive disease. This BLA submission
together with our randomized ResQ201A-NSCLC (NCT06745908) Phase 3
trial in NSCLC is a potential stepping stone towards advancing
novel immunotherapies in this indication for patients who have
failed checkpoint inhibitor therapy.”
Sources:
- https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200167
-
https://docwirenews.com/post/dr-wrangle-discusses-phase-2b-quilt-3-055-trial-at-iaslc-2024-world-conference-on-lung-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 receptor 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 ImmunityBio’s anticipated
submission of a supplemental BLA for ANKTIVA plus BCG in BCG
unresponsive NMIBC in the papillary indication, ImmunityBio’s
anticipated regulatory submission with the FDA for an alternative
source of BCG using the BCG manufactured by Serum Institute of
India, ImmunityBio’s anticipated submission of a BLA for second-
and third-line treatment for NSCLC patients who are progressing on
checkpoint inhibitors, commercial launch activities and market
access initiatives, medical insurance coverage and reimbursement,
market data, clinical trial data and potential results to be drawn
therefrom, the development of therapeutics for cancer and
infectious diseases, potential regulatory pathways and the
regulatory review process and timing thereof, potential expansion
of patient populations or 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, ImmunityBio’s approved product and
investigational agents as compared to existing treatment options,
and the supply of BCG, 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) whether the FDA will accept the
BLAs and other regulatory submissions referenced herein for filing,
(ii) whether the FDA will ultimately approve such BLAs and
submissions and the risks and uncertainties associated with the
regulatory review process and timing thereof, (iii) risks and
uncertainties regarding commercial launch execution, success and
timing, (iv) risks and uncertainties regarding market access
initiatives and timing, (v) whether clinical trials will result in
registrational pathways and the risks and uncertainties regarding
the regulatory submission, review and approval process, (vi)
whether clinical trial data will be accepted by regulatory
agencies, (vi) whether the BCG manufactured by Serum will receive
regulatory approval in the U.S. and/or other regions, (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) the risks and uncertainties associated with third party
collaborations and agreements and ImmunityBio’s reliance upon third
parties for manufacturing, shipping, testing and other activities,
(xiii) ImmunityBio’s ability to successfully commercialize its
approved product and product candidates, (xiv) ImmunityBio’s
ability to scale its manufacturing and commercial supply operations
for its approved product and future approved products, and (xv)
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
nonmuscle 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 Intravesical 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 ImmunityBio at 1-877-ANKTIVA (1-877-265-8482)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250115296860/en/
Investors Hemanth Ramaprakash, PhD, MBA +1-858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media Sarah Singleton +1-415-290-8045
Sarah.Singleton@ImmunityBio.com
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