- A recombinant ‘ACE2 Decoy’ shows robust binding to current
SARS-CoV-2 variants and potential to outsmart viral evolution
against antibodies
- Traps and neutralizes live SARS-CoV-2 viruses with the
potential of a hAd5 ACE2 Decoy to serve both as a therapeutic and a
protective vaccine
- Preclinical studies and GMP manufacturing of hAd5 ACE2 decoy
COVID therapeutic in progress
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy
company, today announced it is developing a novel hAd5 ACE2 Decoy
therapeutic vaccine to neutralize the SARS-CoV-2 virus, including
the E484K and N501Y mutations. The company presented the results in
an oral presentation at the 28th Conference on Retroviruses and
Opportunistic Infections (CROI) and published the positive findings
of high binding affinity to the variants in preprint server,
bioRxiv entitled: “A recombinant ACE2 triple decoy that traps and
neutralizes SARS-CoV-2 shows enhanced affinity for highly
transmissible SARS-CoV-2 variants.”
The hAd5 ACE2 Decoy candidate is based on modified ACE2
receptors that would compete with ACE2 on the cells of respiratory
tract for binding of the SARS-CoV-2 virus. The ACE2 Decoy would
trap the virus, preventing it from infecting cells and facilitate
clearance of the virus from the body. ImmunityBio’s advanced
molecular dynamic simulation capability previously reported in
December was leveraged to design the ACE2 Decoy so it would have
higher affinity for the virus, including SARS-CoV-2 variants, than
natural ACE2 found on cells.
“The rapid mutation of the SARS-CoV-2 virus, predominantly in
the structure of the spike protein, and the emergence of variants
over-taking the ‘first wave’ virus poses a real threat to our
ability to end the pandemic,” said Patrick Soon-Shiong, M.D.,
Executive Chairman of ImmunityBio. “Our goal is to outsmart these
variants by trapping them with decoy versions of the ACE2 receptor,
and the findings we presented at CROI show our lead ACE2 Decoy
binds with even greater affinity to the concerning viral variants
with E484K and N501Y mutations. These promising results warrants
our decision to advance a second hAd5 therapeutic vaccine into
clinical development.”
hAd5 ACE2 Decoy Therapeutic
The CROI presentation, titled “A SARS-CoV-2 Neutralizing ACE2
Decoy Shows High Affinity for N501Y and L452R Variants,”
highlighted ImmunityBio’s development of a recombinant protein
construct designed to act as a ‘decoy’ human angiotensin converting
enzyme 2 (ACE2) receptor that would compete with ACE2 on cells of
the respiratory tract to bind the receptor binding domain (RBD) of
the SARS-CoV-2 spike protein. An effective, high-affinity decoy
could potentially be used as a COVID-19 therapeutic by
out-competing human ACE2 receptors for binding to SARS-CoV-2 S RBD,
thereby inhibiting infection events in vivo. It also has the
potential to be used as a prophylactic that might be administered
to individuals at high risk for infection as a complement to
vaccination to assure protection.
Given the recent emergence and rapid spread of COVID-19 cases
due to several SARS-CoV-2 variants with mutations in the S RBD,
including variants originating in the United Kingdom, South Africa
and California, ImmunityBio scientists sought to identify a single
ACE2 decoy candidate with robust binding affinity across wild-type
and variant SARS-CoV-2 S RBDs, which might thus demonstrate
efficacy in neutralizing infection with SARS-CoV-2 of any known
genotype.
The ACE2 Decoy not only maintains its high affinity for S RBD
expressing these mutations, but shows enhanced affinity for S RBD
expressing the N501Y or L452R mutations and the highest affinity
for S RBD expressing both the E484K and N501Y mutations. The
candidate warrants continued development, beginning with testing in
challenge studies.
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 an unparalleled 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 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. 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. These 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) potential adverse effects or
changes to relationships with employees, suppliers or other parties
resulting from the completion of the merger , (ii) the outcome of
any legal proceedings that may be instituted against the parties
and others related to the merger, (iii) unexpected costs, charges
or expenses resulting from the merger, (iv) uncertainty of the
expected financial performance of the combined company following
completion of 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,
(v) 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, (vi) inability to
retain and hire key personnel, and (vii) the unknown future impact
of the COVID-19 pandemic delay on certain clinical trial 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 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/20210311005349/en/
Investors Sarah Singleton ImmunityBio 844-696-5235,
Option 5
Media Amy Jobe, Ph.D. LifeSci Communications 315-879-8192
ajobe@lifescicomms.com
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