- The Phase 1/2/3 trial will study the efficacy, safety, and
immunogenicity of ImmunityBio’s T-Cell COVID-19 vaccine as a boost
in participants who have already received a spike-only
antibody-based vaccine
- The study is designed to explore whether the T-cell-based
vaccine could prevent breakthrough infections from the Delta
variant in health care workers who are already vaccinated
- Goal of the second-generation hAd5 S+N T-Cell COVID-19 vaccine
is to potentially provide increased protection and long-term
immunity against the multiple variants and third wave infections
currently affecting South Africa and other countries
- Phase 1 studies of subcutaneous dosing in the US have
demonstrated no serious adverse events and potent T-cell responses
after a single prime dose
ImmunityBio, Inc., (NASDAQ: IBRX), a publicly traded
immunotherapy company, today announced authorization from the South
Africa Health Products Regulatory Authority (SAHPRA) to proceed
with the South Africa Sisonke T-Cell Universal Boost trial. The
Phase 1/2/3 study, which will begin in Q3 2021, is designed to
evaluate hAd5 Spike + Nucleocapsid (S+N) as a boost for South
African healthcare workers previously vaccinated with an S-only
vaccine.
“With the virus continuing to spread, moving forward with this
boost trial is crucial,” said Leonard Sender, M.D., Chief Operating
Officer of ImmunityBio. “We are encouraged by the preliminary
safety findings in our ongoing Phase 1 studies in both the U.S. and
South Africa. In addition, our U.S. data show that just a single
prime subcutaneous vaccination with our COVID-19 vaccine candidate
induces a 10-fold increase in T cell response—equivalent to T cell
responses from patients previously infected with SARS-CoV-2. We
have also shown that the T-cell responses are maintained against
variants, which is critical to providing protection against this
ever-changing virus.”
In the trial, the effect of combining vaccination by two routes
of administration—subcutaneous (SC) and sublingual (SL)—will be
assessed. This combination has the potential to deliver protection
from the virus with a single jab followed by droplets placed under
the tongue. Methods that do not require injection such as SL,
intranasal, and oral capsule offer potential advantages depending
on the participant’s needs or situation. Sublingual administration
results in the most rapid absorption, while nasal spray or oral
capsule delivery have the potential to provide mucosal immunity,
which could reduce both the chance of infection and potential
spread of the virus via the respiratory tract. The three non-jab
formulations also can be administered without a trained healthcare
worker and are easier to transport and store. The SL and nasal
routes of administration are also currently being tested in a
separate Phase 1 trial in South Africa.
“The number of new cases in South Africa is frightening,
particularly when you consider recent data suggesting currently
available COVID-19 vaccines may not provide the immune memory
needed to fend off infection from future variants. This highlights
an urgent need for a boost dose that confers long-term protection
by activating both antibodies and T cells, ” said Patrick
Soon-Shiong, M.D., Founder and Executive Chairman of
ImmunityBio.
“Several peer-reviewed studies demonstrate that patients who
have recovered from SARS-CoV in the 2003 outbreak possess long
lasting memory T cells reactive to the nucleocapsid protein of
SARS-CoV 17 years after infection. While antibodies block infection
when present, T cells are vital for long-term immune memory. We are
excited to begin this controlled, randomized trial of boosting a
previously administered DNA-based viral vector vaccine with our own
Ad5 dual-antigen S plus N vaccine to see if it can augment
protection in participants who have received the S-based vaccine
alone,” continued Soon-Shiong.
ImmunityBio’s COVID-19 Trials ImmunityBio is addressing
the serious need for a boost vaccine by conducting or imminently
planning five COVID-19-related studies, three in South Africa and
two in the U.S.
This is to our knowledge the first randomized control trial to
study a heterologous boost of an S-only vaccine with an Ad5 S+N
vaccine boost versus a single S-only prime vaccine as control. The
endpoints of the Sisonke T-cell Boost trial are to examine whether
the boost could reduce breakthrough infections currently occurring
in South Africa at a rapid rate.
About hAd5 T-Cell-Based, Viral-Vector Vaccine Candidate
This second-generation hAd5 viral-vector vaccine is unique in
targeting both S and N SARS-CoV-2 proteins to generate B and T cell
memory to these antigens and, potentially, long-term immunity to
the virus. Most of the COVID-19 vaccines approved by the FDA or in
late-stage clinical trials deliver only the S protein which, by
some estimates, has already mutated thousands of times.
Another unique characteristic of the hAd5 design is its use of a
second-generation hAd5 platform that was developed to elicit
anti-SARS-CoV-2 immune responses even in Ad-immune individuals,
meaning subjects can receive the vaccine multiple times, if
necessary. The stimulation of anti-hAd5 immune responses is
attenuated with the second-generation platform in comparison with
the first-generation platforms due to additional genetic
deletions.
Finally, ImmunityBio’s novel hAd5 vaccine candidate has been
developed in four formulations for different routes of
administration: SC injection, SL drops, intranasal spray, and a
room-temperature-stable oral capsule that could potentially
overcome the cold-chain distribution hurdles affecting many current
COVID-19 vaccines.
About ImmunityBio ImmunityBio is a leading
late-clinical-stage immunotherapy company developing
next-generation therapies that drive immunogenic mechanisms for
defeating cancers and infectious diseases. The company’s
immunotherapy platform activates both the innate (natural killer
cell and macrophage) and adaptive (T cell) immune systems to create
long-term “immunological memory.”
ImmunityBio has a comprehensive immunotherapy pipeline with more
than 40 clinical trials (company sponsored or investigator
initiated)—of which 25 are at Phase II and III stage of
development—across 19 indications in solid and liquid cancers and
infectious diseases. Currently 17 first-in-human immunotherapy
agents are in clinical testing and, to date, over 1,800 patients
have been studied with our antibody cytokine fusion proteins,
albumin chemo immunomodulators, Adeno and yeast vaccines and our
off-the-shelf natural killer cell products. Anktiva™ (ImmunityBio’s
lead cytokine infusion protein) is a novel interleukin-15 (IL-15)
superagonist complex and has received Breakthrough Therapy and Fast
Track Designations from the U.S. Food and Drug Administration (FDA)
for BCG-unresponsive CIS non-muscle invasive bladder cancer
(NMIBC).
The company’s platforms are based on the foundation of four
separate modalities: Antibody cytokine fusion proteins, synthetic
immunomodulators, second-generation human adenovirus (hAd5) and
yeast vaccine technologies, and state-of-the-art, off-the-shelf
natural killer cells, including autologous and allogenic
cytokine-enhanced memory NK cells. ImmunityBio is currently
developing a dual construct COVID-19 vaccine candidate using its
hAd5 platform.
ImmunityBio is a leading producer of cryopreserved and clinical
dose forms of off-the-shelf natural killer (NK) cell therapies. The
company has established GMP manufacturing capacity at scale with
cutting-edge cell manufacturing expertise and ready-to-scale
facilities, as well as extensive and seasoned R&D, clinical
trial, and regulatory operations and development teams. 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, including the planned
timing of the initiation of the Company’s trial in South Africa and
the development of a boost. 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,” “could,”
“estimates,” “expects,” “intends,” “may,” “plans,” “potential,”
“predicts,” “projects,” “seeks,” “should,” “will,” and variations
of such words or similar expressions. Statements of past
performance, efforts, or results of our 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 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) inability to retain and hire key
personnel, (iii) uncertainty of the expected financial performance
and successful integration of the combined company following
completion of the recent merger of ImmunityBio with NantCell (the
“Merger”), including the possibility that the expected synergies
and value creation from the Merger will not be realized or will not
be realized within the expected time period, (iv) whether interim,
initial, “top-line” and preliminary data from our clinical trials
that we announce or publish from time to time may change as more
patient data become available and are subject to audit and
verification procedures that could result in material changes in
the final data, (v) our ability to obtain additional financing to
fund our operations and complete the development and
commercialization of our various product candidates, and (vi) the
unknown future impact of the COVID-19 pandemic delay on certain
clinical trials or their milestones and/or ImmunityBio’s 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 8-K filed with the
U.S. Securities and Exchange Commission (“SEC”) on March 10, 2021,
Form 10-Q filed with the SEC on May 14, 2021 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/20210714005348/en/
Investors Sarah Singleton ImmunityBio, Inc. 844-696-5235,
Option 5 Media Katie Dodge Salutem 978-360-3151
Katie.Dodge@salutemcomms.com
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