iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a biotech
innovator and biologics contract manufacturing organization, today
provided an update on its IBIO-201 program and reported on its
progress in developing a second-generation subunit vaccine
candidate, IBIO-202, being designed for the prevention of
SARS-CoV-2 infection.
IBIO-201, the Company’s vaccine candidate
combining antigens derived from the spike protein (“S protein”)
fused with iBio’s patented LicKM™ booster
molecule, recently completed IND-enabling toxicology studies. The
studies identified no adverse effects at low or high doses.
“Combined with data from previous
immune-response studies, these pathology results help demonstrate
the potential value of LicKM as a useful tool in
our vaccine development toolbox,” said Tom Isett, Chairman and CEO
of iBio.
The Company also reported on development of
IBIO-202, a subunit vaccine candidate that targets the nucleocapsid
protein (“N protein”) of SARS-CoV-2. N proteins of many
coronaviruses are highly immunogenic and are expressed abundantly
during infection. In addition, the N protein is more highly
conserved than the S protein, and therefore new viral variants may
be less likely to escape vaccine protection.
"In light of the successful global roll-out of
COVID-19 vaccines targeting the S protein and the emergence of
variant strains of the disease, we decided to focus our efforts on
the continued development of IBIO-202 as a differentiated vaccine
candidate,” commented Mr. Isett. “The COVID-19 vaccine space
remains highly competitive, with multiple approved vaccines in use
in many countries. Nevertheless, various unmet needs remain,
including: vaccines that provide broader protection against
variants; the potential requirement for annual vaccine boosters;
vaccines that do not require significant cold chain management;
vaccines with alternative routes of administration; pan-coronavirus
vaccines; and wider vaccine availability in developing countries,"
said Mr. Isett.
Using its plant-based
FastPharming® System, iBio has successfully
expressed N protein antigens and has initiated both intramuscular
and intranasal preclinical studies to identify favorable
antigen-adjuvant combinations. Results are expected in early Q1
FY2022. iBio recently filed four provisional patent applications
with the U.S. Patent and Trademark Office in support of the
IBIO-202 program.
“Immunization with more conserved sequences,
such as the N protein, is expected to generate T-cells that could
clear spike protein variant viruses in addition to the original
virus,” said Martin Brenner, DVM. Ph.D., iBio’s CSO. “The N protein
strategy of IBIO-202 is complementary to existing first-generation,
S protein-directed vaccines and may be suitable as a more universal
coronavirus vaccine.”
In parallel with the development of IBIO-202,
the Company continues to evaluate the potential of a multi-subunit
vaccine candidate to further increase vaccine protection from
variants by targeting two or more important elements of the
SARS-CoV-2 virus.
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 on the FastPharming Platform,
which include biopharmaceuticals for the treatment of fibrotic and
infectious diseases, amongst others. The Company’s subsidiary, iBio
CDMO LLC, provides FastPharming Contract
Development and Manufacturing Services, including
Glycaneering™ Development Services for advanced
recombinant protein design. For more information, visit
www.ibioinc.com.
FORWARD-LOOKING
STATEMENTSCertain 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 value of LicKM™ as a useful
tool in the Company’s vaccine development toolbox, using the N
protein to generate T-cells that could clear spike protein variant
viruses in addition to the original virus, immunization with more
conserved sequences, such as the N protein, protecting against a
broader range of virus variants, the N protein strategy of IBIO-202
being suitable as a more universal coronavirus vaccine, new viral
variants being less likely to escape vaccine protection with the N
protein, and plans to develop one or more second-generation subunit
vaccines to further increase vaccine protection from variants by
targeting two or more important elements of the SARS-CoV-2 virus.
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 and develop one or more second-generation
subunit vaccines, the N protein strategy of IBIO-202 being suitable
as a more universal coronavirus vaccine and protecting against a
broader range of virus variants, 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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