- BLA for N-803 plus BCG in high-risk non-muscle-invasive bladder
cancer (NMIBC) was resubmitted to the Agency on October 23,
2023
- A new PDUFA date of April 23, 2024 has been communicated by the
Agency
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy
company, today announced that the U.S. Food and Drug Administration
(FDA) has accepted for review ImmunityBio’s resubmission of its
Biologics License Application (BLA) for N-803, a first-in-class
IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the
treatment of BCG-unresponsive non-muscle-invasive bladder cancer
carcinoma in situ (CIS) with or without Ta or T1 disease, and
considered it as a complete response to the FDA’s May 9, 2023
complete response letter. The FDA has set a user fee goal date
(PDUFA date) of April 23, 2024.
“We are pleased that the FDA has accepted ImmunityBio’s
resubmission of the BLA as a complete response, following our
productive interactions leading up to the resubmission. We look
forward to working closely with the Agency to finalize the review
and to bringing this important immune-enhancing therapeutic to
patients suffering from bladder cancer,” said Patrick Soon-Shiong,
M.D., Executive Chairman and Global Chief Scientific and Medical
Officer at ImmunityBio.
ImmunityBio’s IL-15 superagonist N-803 (also called Anktiva®
and nogapendekin alfa inbakicept)
The cytokine interleukin-15 (IL-15) plays a crucial role in the
immune system by affecting the development, maintenance, and
function of the natural killer (NK) and T cells. N-803 is a novel
investigational IL-15 superagonist complex consisting of an IL-15
mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion
protein. Its proposed mechanism of action is direct specific
stimulation of CD8+ T cells and NK cells through beta gamma T-cell
receptor binding with generation of memory T-cells while avoiding
T-reg stimulation. N-803 is designed to have improved
pharmacokinetic properties, longer persistence in lymphoid tissues
and enhanced anti-tumor activity compared to native, non-complexed
IL-15 in vivo.
N-803 is currently being evaluated in adult patients in two
clinical NMIBC trials. QUILT-2.005 is investigating use of N-803 in
combination with BCG for patients with BCG-naïve NMIBC; QUILT-3.032
is studying N-803 in combination with BCG in patients with
BCG-unresponsive NMIBC CIS and Papillary Disease.
N-803 is investigational. Safety and efficacy have not been
established by any Health Authority or Agency, including the
FDA.
About ImmunityBio
ImmunityBio is a vertically-integrated, clinical-stage
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 ImmunityBio’s resubmission of
its BLA and review thereof, ImmunityBio’s belief that the BLA
resubmission addresses the issues in the Complete Response Letter,
the timing of the regulatory review process for the BLA
resubmission, the development or commercialization of N-803 plus
BCG or other therapeutics for cancer indications and related
business strategies, potential regulatory pathway for certain of
ImmunityBio’s product candidates and target indications, and
ImmunityBio’s investigational agents as compared to existing
treatment options, among others. While ImmunityBio believes the BLA
resubmission addresses the issues identified in the CRL, there is
no guarantee that the FDA will ultimately agree that such issues
have been successfully addressed and resolved. 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 the regulatory review process, (ii) whether or not
the FDA will ultimately determine that the BLA resubmission is
complete, (iii) uncertainties regarding the timeline of FDA review
of the resubmitted BLA, (iv) any inability to successfully work
with the FDA to find a satisfactory solution to address any
concerns in a timely manner or at all during the review process for
the BLA, including any inability to provide the FDA with data,
analysis or other information sufficient to support an approval of
the BLA, (v) the ability of ImmunityBio and its third party
contract manufacturing organizations to adequately address the
issues raised in the CRL, (vi) any potential facility re-inspection
that may be required regarding ImmunityBio’s third party contract
manufacturing organizations or otherwise, (vii) whether the FDA
accepts the data and results as included in the BLA resubmission at
levels consistent with the published results, or at all, (viii) the
ability of ImmunityBio to execute a partnering relationship with a
large biopharmaceutical company for commercialization of N-803 plus
BCG for intravesical administration on acceptable terms, if at all,
(ix) the ability of ImmunityBio to continue its planned preclinical
and clinical development of its development programs, and the
timing and success of any such continued preclinical and clinical
development and planned regulatory submissions, (x) ImmunityBio’s
ability to retain and hire key personnel, (xi) ImmunityBio’s
ability to obtain additional financing to fund its operations and
complete the development and commercialization of its various
product candidates, (xii) ImmunityBio’s ability to successfully
commercialize its product candidates and uncertainties around
regulatory reviews and approvals, (xiii) ImmunityBio’s ability to
scale its manufacturing and commercial supply operations for its
product candidates 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 1,
2023 and the Company’s Form 10-Q filed with the SEC on August 8,
2023, 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/20231026155505/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@Salutem.com
ImmunityBio (NASDAQ:IBRX)
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