- Confirmatory trial builds on results of QUILT 3.055, a Phase 2
trial demonstrating ANKTIVA rescued T cells and activity of
checkpoint inhibitors (CPIs) in patients with non-small cell lung
cancer (NSCLC), who progressed on CPI therapies
- QUILT 3.055 showed prolonged overall survival in these second-
and third-line NSCLC patients exceeding historical survival rates
following chemotherapy
- ImmunityBio anticipates submitting a biologics license
application (BLA) in 2025 for this indication based on the QUILT
3.055 data
- The ImmunityBio patent for ANKTIVA and CPI combinations extends
to 2035
ImmunityBio, Inc. (NASDAQ: IBRX) today announced it has entered
into a collaboration and supply agreement with BeiGene, Ltd. (to be
changed to BeOne Medicines, Ltd.), a global oncology company, to
conduct a confirmatory randomized Phase 3 clinical trial
(ResQ201A-NSCLC), combining BeiGene's tislelizumab, a PD-1
checkpoint inhibitor (CPI), and ImmunityBio's ANKTIVA (nogapendekin
alfa inbakicept-pmln). The Phase 3 ResQ201A-NSCLC study
(NCT06745908) aims to confirm the efficacy and safety of
combination ANKTIVA plus CPI therapy previously demonstrated in the
trial QUILT 3.055 and provide evidence of the potential for these
two immunotherapeutic agents to improve overall survival in
patients with advanced or metastatic NSCLC who have acquired
resistance to immune CPI therapy.
The Phase 3 trial design is based on the synergistic potential
already demonstrated in the QUILT 3.055 study that a CPI and
ANKTIVA, an IL-15 superagonist, prolongs overall survival (OS) in
the study population compared to historical controls in this
setting. In Phase 1 and 2 studies, ANKTIVA has demonstrated the
capability of rescuing T cells, and thus CPI efficacy, through the
molecule’s unique mechanism of action. ANKTIVA is the first FDA
approved molecule that has demonstrated the ability to increase
lymphocytes via its proliferative IL-15 stimulatory action. ANKTIVA
stimulates the proliferation of natural killer cells and CD4+ and
CD8+ T cells, which in turn restores MHC-1 presentation, allowing T
cells to regain their cytotoxic activity, and thereby rescue CPI
activity.
Multiple Phase 1 and 2 studies have demonstrated prolonged
overall survival with this combination approach, in comparison to
historical results with chemotherapy in this patient population.
1,2 In these multi-site trials, the combination of ANKTIVA plus the
CPI, with no intervening therapy when the patient progressed on the
CPI, demonstrated a median OS (mOS) of 17.1 months (95% CI: 4.6,
NR) in patients with PD-L1 ≥ 50% and a mOS of 19.6 months (95% CI:
6.2, NR) in patients who relapsed on checkpoint inhibitor. QUILT
3.055 confirmed these findings with a mOS of 14.1 months (95% CI:
11.7, 16.3), as presented at World Lung on Oct 2024.3, 4
The mechanism of the rescue of NSCLC patients who had failed
checkpoint inhibitors is through the MOA of ANKTIVA in which NK
cells and T cells are proliferated with rescue of lymphocytes and
MHC-I. Proliferation of lymphocytes has been observed In healthy
volunteers, and is due to the unique mechanism of ANKTIVA as an
IL-15 agonist as described on the package insert. 5,6 On the basis
of these findings, ImmunityBio intends to file a BLA for ANKTIVA +
checkpoint inhibitor in second / third line NSCLC patients who have
progressed on CPI therapy.
ImmunityBio will conduct this confirmatory Phase 3 trial
globally across multiple sites; when fully enrolled, it is expected
to include 462 participants.
“The challenge oncologists face in the next five years is how to
manage the many patients who do not respond to CPI therapy after an
initial response,” said Dr. Patrick Soon-Shiong, Founder, Executive
Chairman and Global Chief Scientific and Medical Officer of
ImmunityBio. “Currently, options are limited for these second- and
third-line patients with NSCLC whose cancer continues to progress
on CPIs. The finding that these ‘cold’ tumors, which have evaded T
cells, can now be rendered ‘hot’ through the activation of natural
killer cells with ANKTIVA, is exciting. To our knowledge, ANKTIVA
is the first approved cytokine to address low white cell count
(lymphopenia), which occurs following chemo-immunotherapy and
radiotherapy. On the basis of ANKTIVA’s mechanism of action of
proliferating T cells as well as NK cells, ANKTIVA has the
potential to serve as the foundational cytokine to address loss of
activity in the multiple tumors in which CPIs are approved.”
According to the American Cancer Society, lung cancer is the
second most common cancer in the U.S. In 2025, it is estimated that
226,650 new cases of lung cancer will be diagnosed in the U.S. and
124,730 deaths will be attributed to the disease. NSCLC accounts
for about 87% of all lung cancer diagnoses, and there are very few
successful treatment options for these patients once the cancer
spreads beyond the lungs.
“ImmunityBio and BeiGene share a similar vision to advance the
next generation of oncology immunotherapies to address unmet needs.
We are excited to explore the potential of our PD-1 inhibitor,
tislelizumab, in combination with ANKTIVA,” said John V. Oyler,
Co-Founder, Chairman and CEO of BeiGene. “I’ve admired Dr.
Soon-Shiong’s bold approach to medicine and look forward to working
with him and his team as the ResQ201A-NSCLC study gets underway.
Together, we hope to help metastatic lung cancer patients who may
have few options left.”
The primary endpoint of the study is overall survival, with
secondary endpoints including disease control rate,
progression-free survival, objective response rate and safety.
For more information about the trial, please visit
www.Immunitybio.com.
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 ImmunityBio.com (Founder’s
Vision) and 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 (Founder’s Vision) and connect
with us on X (Twitter), Facebook, LinkedIn, and Instagram.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines Ltd.,
is a global oncology company that is discovering and developing
innovative treatments that are more affordable and accessible to
cancer patients worldwide. With a broad portfolio, it is expediting
development of its diverse pipeline of novel therapeutics through
its internal capabilities and collaborations. It is committed to
radically improving access to medicines for far more patients who
need them. Its growing global team of over 11,000 colleagues spans
five continents. To learn more about BeiGene, please visit
www.beigene.com and follow it on LinkedIn, X (formerly known as
Twitter), Facebook and Instagram.
References:
-
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30148-7/abstract
- https://www.jto.org/article/S1556-0864(19)33786-4/fulltext
- https://doi.org/10.1200/JCO.2021.39.15_suppl.2596
- https://www.jto.org/article/S1556-0864(24)00917-1/abstract
-
https://journals.aai.org/jimmunol/article/208/6/1362/234562/Phase-I-Trial-Characterizing-the-Pharmacokinetic
-
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf
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 clinical supply agreement
with BeiGene in connection with the proposed RESQ201A-NSCLC
clinical trial as described herein, ImmunityBio’s intent to submit
a BLA for second- and third-line treatment of NSCLC patietns who
are progressing on checkpoint inhibitors, ImmunityBio’s plan to
conduct RESQ201A-NSCLC as a confirmatory registrational trial
globally, anticipated site and patient enrollment for
RESQ201A-NSCLC, market data, 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) whether the FDA and/or other
regulatory agencies will accept or approve the clinical trial
strategy and regulatory pathway as described herein, (ii) whether
the FDA will accept the BLA and other regulatory submissions
referenced herein for filing, (iii) whether the FDA will ultimately
approve such BLA and submissions and the risks and uncertainties
associated with the regulatory review process and timing thereof,
(iv) risks and uncertainties regarding third party collaborations
and supply agreements and performance outside of ImmunityBio’s
control, (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, (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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250129629819/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
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