- QUILT 3.055 trial completed and shows median overall survival
almost double that of standard of care chemotherapy in 2nd- and
3rd-line non-small cell lung cancer (NSCLC) patients whose cancer
did not respond to checkpoint inhibitors with or without
chemotherapy
- Positive results seen in both PD-L1 negative and PD-L1 positive
participants with NSCLC
- Data reaffirms the mechanism of action of ANKTIVA as an
immune cell enhancer that activates natural killer (NK) cells and
memory T cells to rescue checkpoint inhibitor (pembrolizumab,
nivolumab, atezolizumab) failures across multiple tumor types
- Meeting scheduled with FDA in June to discuss path to
registration filing of ANKTIVA plus checkpoint inhibitors in 2nd-
and 3rd-line NSCLC patients whose cancer previously did not respond
to checkpoint therapy
- $100 million in non-dilutive cash infusion with ANKTIVA
approval brings cash-on-hand to approximately $240 million for
launch of ANKTIVA in non-muscle invasive bladder cancer
(NMIBC)
- Company has scheduled a conference call to discuss registration
plans for NSCLC, status of ANKTIVA launch readiness for NMIBC, and
ANKTIVA as the backbone of our clinical trial pipeline for multiple
tumor types
ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company,
today announced positive overall survival results in the QUILT
3.055 study of 2nd- and 3rd-line NSCLC patients who progressed
after checkpoint inhibitor therapy (pembrolizumab, nivolumab, or
atezolizumab) and standard-of-care chemotherapy to be discussed
during the upcoming conference call. The results continue to
reinforce ImmunityBio’s belief in the unique mechanism of action of
ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) and its
potential efficacy as a next-generation immunotherapy across
multiple solid and liquid tumor types.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240424428572/en/
In NSCLC patients who relapsed or were refractory to checkpoint
inhibitors, ANKTIVA was administered together with the same
checkpoint inhibitor. The addition of ANKTIVA resulted in the
rescue of the checkpoint therapy efficacy, with significant
prolongation of overall survival. These positive results were noted
regardless of the patient’s PD-L1 status, consistent with the
mechanism of action of ANKTIVA in activating and proliferating
natural killer cells, and stimulating CD8+ Killer Memory T cells.
This prolongation of survival in NSCLC following checkpoint failure
is consistent with ImmunityBio’s findings of durable complete
responses following BCG failure in NMIBC.
A meeting with the FDA has been scheduled for June to discuss
the company’s overall survival results in PD-L1 negative and
positive patients and registration plans for 2nd-line and 3rd-line
NSCLC patients whose cancer did not respond or continue to respond
to checkpoint therapy and for whom few alternative therapies are
available.
The positive overall survival data of patients enrolled in QUILT
3.055, a basket trial across multiple tumor types, in which
checkpoint inhibitors failed, will be discussed, along with the
status of launch readiness for ANKTIVA for its recently approved
indication in NMIBC on an investor conference call Friday, April 26
at 8 am PDT/11 am EDT.
“The results we noted with the completion of the QUILT 3.055
basket trial across multiple tumor types in patients with
late-stage cancers for whom standard of care plus checkpoints
failed, validates our hypothesis that orchestration of NK cells
with killer T cells and memory T cells could result in meaningful
clinical improvements to current standards of care. We hypothesized
that activation and proliferation of natural killer cells through
IL-15 stimulation could rescue T cells after checkpoint failure,
regardless of tumor type or of tumor location. As with non-muscle
invasive bladder cancer, we believe that ANKTIVA enhanced the NK
and T cell activity critical for targeting and killing cancer cells
which have entered the phase of tumor evasion and resistance,” said
Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief
Scientific and Medical Officer at ImmunityBio. “QUILT 3.055 was the
initial and seminal study of our Cancer Moonshot program launched
in January 2016 (see related video here). The findings of a
significant extension of overall survival in 2nd- and 3rd-line lung
cancer affirms that combination therapy, with the orchestration of
the innate and adaptive immune system, could potentially lead to
the evolution of immunotherapy beyond T cells for all cancer
patients. We are excited that these results continue to demonstrate
the broad potential for ANKTIVA across multiple tumor types and its
role as the next-generation immunotherapy. We are committed to
pursuing additional indications for ANKTIVA in our pipeline with a
mission to deliver new hope to patients with serious, advanced
cancers where standard therapies have failed.”
The QUILT trials initiated since the launch of the Cancer
Moonshot program across multiple tumor types can be found on
ImmunityBio.com and are summarized in the figure accompanying this
announcement. As can be seen, ANKTIVA (N-803) serves as the
backbone to the immunotherapy vaccine across multiple tumor types
at late-stage with exploratory evidence of complete remissions.
Updates to this figure denoting the QUILT trials at the time of
publication in 2021 will be forthcoming.
According to the American Cancer Society, lung cancer is the
second most common cancer in the U.S. In 2023, it is estimated that
238,340 new cases of lung cancer will be diagnosed in the U.S. and
127,070 deaths will be attributed to the disease. NSCLC accounts
for about 80% to 85% of all lung cancers diagnoses and there are
very few successful treatment options for these patients once the
cancer spreads beyond the lungs.
The development of checkpoint inhibitors in NSCLC has been
revolutionary, doubling the median overall survival in some
settings; however, patient response may be short lived, due to late
response and/or progression after achieving an initial response.
Historical and real-world experience (RWE) data show that the
median overall survival rates in these patients range from 7 to 9
months.
In addition, the company will provide information about the
status of launch readiness of ANKTIVA for NMIBC. Presentations by
the company on ANKTIVA data in NMIBC are scheduled at the upcoming
American Urological Association (AUA) conference in San Antonio,
Texas from May 3-6, 2024. It is anticipated the first vials of
ANKTIVA will be available for shipment the week of May 6, 2024.
Further details regarding ANKTIVA as the backbone of
ImmunityBio’s late-stage clinical pipeline across multiple solid
and liquid tumor types will be discussed during the conference
call, along with commercial launch readiness details, and the
corporate financial position to support launch of ANKTIVA for the
U.S. market.
Conference call details:
Investors may access the live audio webcast of the call via this
weblink. A replay of the webcast will be available at
https://ir.immunitybio.com. All participants may join the call by
dialing (800) 579-2543 (U.S. and Canada Toll-Free) or (785)
424-1789 and using the access code ANKTIVA.
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. 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 data and results from clinical
trials and potential implications therefrom, commercialization
plans and timelines, including product availability and shipments,
potential regulatory pathways and approval requests and
submissions, FDA meetings, timelines and potential results
therefrom, the regulatory review process and timing thereof, market
and prevalence data, potential benefits to patients, potential
treatment outcomes for patients, the described mechanism of action
and results and contributions therefrom, information regarding
potential benefit to patients, information regarding ongoing
pre-clinical studies and clinical trials, potential future uses and
applications of ANKTIVA and use in cancer vaccines and across
multiple tumor types, methods, conference call and webcast timing,
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,”
“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 commercial launch execution, success and timing,
(ii) risks and uncertainties related to the regulatory submission
and review process, (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, patient enrollment and planned regulatory submissions,
(iv) the timing and funding of the incremental $100 million of
non-dilutive financing following ImmunityBio’s receipt of FDA
approval of the BLA, (v) ImmunityBio’s ability to retain and hire
key personnel, (vi) ImmunityBio’s ability to obtain additional
financing to fund its operations and complete the development and
commercialization of its various product candidates, (vii)
potential product shortages or manufacturing disruptions that may
impact the availability and timing of product, (viii) ImmunityBio’s
ability to successfully commercialize its product candidates and
uncertainties around regulatory reviews and approvals, (ix)
ImmunityBio’s ability to scale its manufacturing and commercial
supply operations for its product candidates and future approved
products, and (x) 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 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/20240424428572/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
ImmunityBio (NASDAQ:IBRX)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
ImmunityBio (NASDAQ:IBRX)
Gráfica de Acción Histórica
De May 2023 a May 2024