- Company’s first clinical trial studying CAR-NK (CD19 t-haNK)
cellular therapy in liquid tumors
- First natural killer cell-based cellular therapy study
conducted in the continent of Africa
- Complete enrollment currently expected in Q1 2025
Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX),
announced today that the first patients have been dosed in an
initial trial studying the potential of the company’s CAR-NK cell
therapy targeting CD-19 in the treatment of non-Hodgkin’s lymphoma
(NHL). In the QUILT 106 trial, CD19-targeted high-affinity natural
killer (t-haNK) cells are being tested initially as a single agent,
and after demonstrating safety, then in combination with standard
NHL treatment rituximab, in participants with selected CD19+ and
CD20+ relapsed/refractory B-cell NHL. The phase 1, open label
clinical study is designed to enroll up to 10 participants and is
being conducted in Johannesburg, Pretoria, and Bloemfontein, South
Africa.
This is the first cellular-targeted natural killer (NK) cell
therapy study ever to be conducted in South Africa, and is designed
to provide important clinical information on a cancer with a
significant rate of diagnosis in the region, but with few treatment
options. Non-Hodgkin’s lymphoma is the 6th most common malignancy
among people in Sub-Saharan Africa and it is the 4th most diagnosed
cancer in men and the 5th most diagnosed cancer in women in South
Africa, according to the Cancer Association of South Africa.
“This trial is important for ImmunityBio as our first clinical
study of our CAR-NK, CD19 t-haNK cell line, as well as one of our
first studies in liquid tumors,” said Patrick Soon-Shiong, M.D.,
Executive Chairman, Founder and Global Chief Scientific and Medical
Officer at ImmunityBio. “We have chosen to undertake this trial
because Sub-Saharan African and, in particular, South African
populations are often overlooked when it comes to advanced clinical
research, despite the need for innovative immunotherapies in the
region.”
Full patient enrollment in this Phase 1 study of CD19 t-haNK is
currently expected in the first quarter of calendar year 2025 with
topline data readout expected in the second half of the calendar
year 2025.
This study, being conducted in South Africa, is similar to
ImmunityBio’s U.S.-based trial QUILT 3.092, a phase 1 open-label
study of CD19 t-haNK as a single agent and in combination with the
company’s IL-15 superagonist (N-803; ANKTIVA®) and rituximab in
participants with relapsed or refractory NHL.
About the QUILT 106 Study
The Phase 1, first-in-human (FIH), open-label study is designed
to enroll up to 10 participants at sites in Johannesburg, Pretoria,
and Bloemfontein, South Africa with the primary endpoint of the
trial to evaluate the safety and preliminary efficacy of CAR-NK,
CD19 t-haNK as a single agent and in combination with rituximab in
participants with selected CD19+ and CD20+ R/R B-cell non-Hodgkin
lymphoma (NHL). Participants will initially receive a single 3-week
cycle of the CD19 t-haNK as a single-agent regime. Following a
1-week safety pause, participants will then receive a 3-week cycle
of CD19 t-haNK in combination with rituximab. Patients will undergo
multiple assessments of safety and efficacy to help evaluate the
safety of CD19 t-haNK as a single agent and in combination with
rituximab in participants with R/R NHL, who have active disease
after completing ≥ 2 lines of cytotoxic chemotherapy.
About CAR-NK, CD19 t-haNK
CD19 t-haNK is a human, allogeneic, stable clonal NK cell line
generated from the parental activated NK (aNK) cell line (NK-92).
Based on the demonstrated therapeutic efficacy of chimeric antigen
receptor (CAR) targeting and on the important role of FcγR-mediated
antibody-dependent cellular cytotoxicity (ADCC) in the
effectiveness of therapeutic IgG1 monoclonal antibodies, it was
hypothesized that modification of the parental aNK cell line to
stably express both a CD19-targeted CAR and the high-affinity
variant of CD16 would result in potent and selective antitumor
activity. Therefore, the novel CD19 t-haNK cells have been
genetically engineered to stably express 3 main proteins: (1) a
human CD19-targeted CAR; (2) the high-affinity variant of the human
Fcγ receptor (FcγRIIIa/CD16a 158V) for enhanced ADCC; and (3)
endoplasmic reticulum-retained version of human interleukin-2
(ERIL-2) for independent growth.
Non-Hodgkin Lymphoma
Non-Hodgkin lymphoma (NHL) is a heterogeneous disease that most
commonly originates in B lymphocytes. In 2020, according to the
South Africa National Cancer Registry (SANCR 2020), it is estimated
that 1 in 174 men and 1 in 288 women will develop NHL. According to
Global Cancer Observatory (Sung 2021), the incidence of NHL is 4.1%
of all cancers. A comparative study of the distribution of NHL
subtypes in South Africa reported that Southern Africa had a
significantly lower proportion of low-grade B cell NHL (34.3%) and
a higher proportion of high-grade B cell NHL (51.5%) compared to
Western Europe (54.5% and 36.4%) and North America (56.1% and
34.3%) (Perry 2015).
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 www.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 clinical trial plans and timing,
patient enrollment and treatment, timing of data read outs, market
and prevalence data, the regulatory review process and timing
thereof, 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 presentation 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 clinical trial patient enrollment and timing and
potential results, including with respect to the trial described
herein, (ii) risks and uncertainties related to the regulatory
submission and review process, (iii) the ability of ImmunityBio to
fund its ongoing and anticipated clinical trials, (iv) whether
clinical trials will result in registrational pathways and the
risks and uncertainties regarding the regulatory submission, review
and approval process, (v) 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,
(vi) potential delays in product availability and regulatory
approvals, (vii) ImmunityBio’s ability to retain and hire key
personnel, (viii) ImmunityBio’s ability to obtain additional
financing to fund its operations and complete the development and
commercialization of its various product candidates, (ix) potential
product shortages or manufacturing disruptions that may impact the
availability and timing of product, (x) ImmunityBio’s ability to
successfully commercialize its approved product and product
candidates, (xi) ImmunityBio’s ability to scale its manufacturing
and commercial supply operations for its approved product and
future approved products, and (xii) 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 August 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241024393866/en/
Investors Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc. +1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media Sarah Singleton ImmunityBio +1
415-290-8045 Sarah.Singleton@ImmunityBio.com
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