iBio Reports Successful Preclinical Immunization Studies with Next-Gen Nucleocapsid COVID-19 Vaccine Candidate
July 15 2021 - 5:10PM
iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a biotech
innovator and biologics contract manufacturing organization, today
announced that preclinical studies of IBIO-202, its subunit vaccine
candidate that targets the nucleocapsid protein (“N protein”) of
SARS-CoV-2, demonstrated a robust, antigen-specific, memory T-cell
response.
Data on commercially available COVID-19 vaccines
- all of which target the spike protein (“S protein”) - suggests
that neutralizing titers are effective, but likely to wane over
time. In addition, the robustness of T-cell priming and cellular
immunity achieved by S protein-directed vaccines may not be
sufficient to create a durable immune response, especially in the
context of emerging variant strains of the virus. In contrast, the
N protein gene is more conserved and stable than the spike, with
90% amino acid homology and fewer mutations over time. Notably, the
SARS-CoV-2 N protein shares substantial sequence conservation with
the nucleocapsid of other coronaviruses.
It has been observed that the N protein can
induce SARS-specific T-cell proliferation. The IBIO-202
immunization data are consistent with that, as a strong, cytotoxic,
memory T-cell response was seen, rather than an inflammatory
response. In addition, T-cell priming was achieved via both
intramuscular and intranasal administration, allowing for the
further exploration of multiple routes of administration and their
respective benefits.
“Studies of convalescent sera from patients that
have recovered from SARS-CoV-2 infection have shown that the
combination of N-directed and S-directed immunity is important,”
said Martin Brenner, DVM. Ph.D., iBio’s CSO. “Accordingly, we
believe the N protein strategy of IBIO-202 may be complementary
with existing S-directed vaccines, conferring additional protective
effects that more closely mimic the natural immune responses of
patients that have cleared the virus.”
Additional characterization studies of IBIO-202
are ongoing.
About iBio, Inc.
iBio is a global leader in plant-based biologics
manufacturing. Its FastPharming System® combines
vertical farming, automated hydroponics, and novel glycosylation
technologies to rapidly deliver high-quality monoclonal antibodies,
vaccines, bioinks and other proteins. iBio is developing
proprietary products which include biopharmaceuticals for the
treatment of cancers, as well as fibrotic and infectious diseases.
The Company’s subsidiary, iBio CDMO LLC, provides
FastPharming Contract Development and
Manufacturing Services along with Glycaneering
Development Services™ for advanced recombinant protein design. For
more information, visit www.ibioinc.com.
FORWARD-LOOKING STATEMENTS
Certain statements in this press release
constitute "forward-looking statements" within the meaning of the
federal securities laws. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "predict," "forecast," "project," "plan," "intend" or
similar expressions, or statements regarding intent, belief, or
current expectations, are forward-looking statements. These
forward-looking statements are based upon current estimates and
assumptions and include statements regarding the potential of
IBIO-202, the N protein strategy of IBIO-202 being complementary
with existing S protein directed vaccines, conferring additional
protective effects that more closely mimic the natural immune
responses of patients that have cleared the virus and plans to
complete additional characterization studies of IBIO-202. While the
Company believes these forward-looking statements are reasonable,
undue reliance should not be placed on any such forward-looking
statements, which are based on information available to us on the
date of this release. These forward-looking statements are subject
to various risks and uncertainties, many of which are difficult to
predict that could cause actual results to differ materially from
current expectations and assumptions from those set forth or
implied by any forward-looking statements. Important factors that
could cause actual results to differ materially from current
expectations include, among others, the Company’s ability to
successfully complete additional testing planned for IBIO-202, the
N protein strategy of IBIO-202 being complementary with existing S
protein directed vaccines, the Company’s ability to obtain
regulatory approvals for commercialization of its product
candidates, including its COVID-19 vaccines, or to comply with
ongoing regulatory requirements, regulatory limitations relating to
its ability to promote or commercialize the Company’s product
candidates for specific indications, acceptance of the Company’s
product candidates in the marketplace and the successful
development, marketing or sale of the Company’s products, the
Company’s ability to maintain its license agreements, the continued
maintenance and growth of its intellectual property portfolio, the
Company’s ability to establish and maintain collaborations, the
Company’s ability to obtain or maintain the capital or grants
necessary to fund its research and development activities,
competition, the Company’s ability to retain its key employees or
maintain its NYSE American listing, and the other risk factors
discussed in the Company’s most recent Annual Report on Form 10-K
and the Company’s subsequent filings with the SEC, including
subsequent periodic reports on Forms 10-Q and 8-K. The information
in this release is provided only as of the date of this release,
and we undertake no obligation to update any forward-looking
statements contained in this release on account of new information,
future events, or otherwise, except as required by law.
Contact:
Stephen KilmeriBio, Inc.Investor Relations(646)
274-3580 skilmer@ibioinc.com
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