ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy
company, today announced findings from a Phase 1 study showing that
allogeneic cytokine-induced memory-like (CIML) natural killer (NK)
cells used in combination with ImmunityBio’s IL-15 superagonist
N-803 may induce tumor regression associated with persistent CIML
NK cell expansion in advanced head-and-neck cancer patients. The
results indicate the potential for a new treatment approach for the
disease in advanced cases that currently have extremely poor
prognoses.
The data from the proof-of-concept study were presented by Glenn
J. Hanna, M.D., Medical Oncologist with Dana-Farber Cancer
Institute and Assistant Professor of Medicine at Harvard Medical
School at the American Association for Cancer Research (AACR) and
the American Head and Neck Society (AHNS) joint conference in
Montreal, July 7-8, 2023.
Patients with recurrent incurable or metastatic (R/M) head and
neck cancers (HNCs) that do not respond to platinum chemotherapy
and immunotherapy have poor survival rates. Cellular therapies have
emerged as treatments with potential activity in solid tumors.
“It was exciting to observe some tumor regression among heavily
pre-treated patients with advanced head-and-neck cancer using a
live cell therapy approach,” said Dr. Hanna. “I am hopeful that
future studies can build on this work to further evaluate NK and
other immune cell therapies for these cancers.”
This study (NCT04290546) sponsored by Dana-Farber Cancer
Institute investigated allogeneic CIML NK cell infusion followed by
N-803 after lead-in CTLA-4 inhibition (ipilimumab) plus
lymphodepleting (LD) chemotherapy in advanced HNC. The study showed
that tumor regression was associated with expansion of the NK cell
type with cytolytic activity, CD56dimCD16+ NK cells, that target
and kill tumor cells.
This phase 1 single-center trial enrolled 10 patients with R/M
HNC (n=7 HNSCC, n=3 salivary cancer) regardless of human
papillomavirus (HPV) status who had prior platinum chemotherapy and
immunotherapy. Patients in cohort 1 received LD fludarabine (25
mg/m2) and cyclophosphamide (60 mg/m2/kg) on days -6 to -2 prior to
haploidentical CIML NK cell infusion on day 0 (5-10 x 106 viable
cells/kg=dose level 0) followed by N-803 (15 mcg/kg subcutaneously)
starting on day +1 every 21-days for 4-doses. Patients in cohort 2
received the same regimen with a dose of lead-in ipilimumab on day
-7. A total of 6 patients were treated in cohort 1 and 4 patients
in cohort 2.
The primary objective was safety and maximum tolerated dose of
CIML NK cells. The secondary objective was objective response rate
(ORR), progression-free survival (PFS), overall survival (OS), and
phenotypic expansion and function of adoptively transferred NK
cells.
“It is encouraging that allogeneic CIML NK cells supported by
N-803 may induce tumor regression in advanced head-and-neck cancer
patients,” said Patrick Soon-Shiong, M.D., Executive Chairman and
Global Chief Scientific and Medical Officer at ImmunityBio. “These
results may have potential implications for many of the estimated
68,000 men and women in the United States who are diagnosed with
head-and-neck cancers annually, and it is an ongoing pursuit of
ImmunityBio’s technology platform to orchestrate T and NK cells to
fight cancer.”
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 conference participation and
timing, the regulatory review process and timing thereof, timing of
data from the clinical trials for certain of ImmunityBio’s product
candidates, potential implications to be drawn from clinical
trials, the potential for allogeneic CIML NK cells given in
combination with N-803 to induce tumor regression in advanced head
and neck cancer patients, potential new treatment approaches, and
future studies and trials. 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 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, (ii) the risks and uncertainties associated
with the regulatory submission, review and approval process, (iii)
ImmunityBio’s ability to retain and hire key personnel, (iv)
ImmunityBio’s ability to obtain additional financing to fund its
operations and complete the development and commercialization of
its various product candidates, (v) ImmunityBio’s ability to
successfully commercialize its product candidates and uncertainties
around regulatory reviews and approvals, (vi) ImmunityBio’s ability
to scale its manufacturing and commercial supply operations for its
product candidates and future approved products, (vii)
ImmunityBio’s ability to obtain, maintain, protect and enforce
patent protection and other proprietary rights for its product
candidates and technologies, and (viii) the unknown future impact
of the COVID-19 pandemic on certain clinical trials or their
milestones and/or ImmunityBio’s business operations or operating
expenses. 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 May 11, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230710232438/en/
Investors Sarah Singleton ImmunityBio, Inc.
844-696-5235, Option 5 Sarah.Singleton@ImmunityBio.com
Media Greg Tenor Salutem +1 717-919-6794
Gregory.Tenor@Salutem.com
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