iBio Provides Update on IBIO-201 COVID-19 Vaccine Program
August 10 2020 - 7:15AM
iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”), a
biotechnology corporation and biologics contract manufacturing
organization, today provided an update on one of its proprietary
vaccine candidates being designed to prevent infection from the
SARS-CoV-2 virus. iBio is investigating an array of adjuvants in
combination with iBio’s proprietary lichenase carrier molecule
(“
LicKMTM”) fused to a coronavirus subunit protein
(“IBIO-201”) with the goal of producing a safe and effective
vaccine for COVID-19 disease, and especially one for our most
vulnerable populations, including the elderly.
Ten distinct preclinical study arms for the
IBIO-201 antigen-adjuvant combinations have been concluded.
These include combinations delivered via intramuscular and
intranasal routes, and datasets are under evaluation.
Anti-SARS-CoV-2 spike titers to IBIO-201were
observed 21 days after immunization. Titers continued to
increase over the 42-day study. Distinct, favorable Th1 and Th2
immune profiles were observed.
Early functional testing of mouse antisera from
IBIO-201 immunized mice demonstrates the presence of antibodies
that interfere with the binding of SARS-CoV-2 spike protein
sequences to human ACE2 in ex vivo assays. iBio plans to conduct
additional testing of IBIO-201 antisera, including further
evaluations of neutralizing titers in multiple assay formats. In
addition, significant immune profiling studies are ongoing to
evaluate safety and immune protection correlates, including
antigen-specific T cell responses and memory B cell testing. The
additional testing for both IBIO-201 and IBIO-200 is occurring in
collaboration with the Texas A&M University System (“TAMUS”)
laboratories.
“We are encouraged by these pre-clinical data,
which demonstrate IBIO-201’s ability to generate an immune response
to SARS-CoV-2 sequences and neutralize protein interaction,” said
Tom Isett, Chairman & CEO of iBio. “We expect to gain more
insight as we complete data analysis of both of our COVID-19
vaccine candidates.”
About iBio’s COVID-19 Vaccine
Development Programs
On March 11, 2020, the Company filed four
provisional patent applications with the U.S. Patent and Trademark
Office in support of its COVID-19 vaccine platforms. The virus-like
particle (“VLP”) program (“IBIO-200”) was subsequently announced on
March 18, 2020. The LicKM-Subunit program
(“IBIO-201”) was announced on June 3, 2020. If the program(s) move
into clinical trials, iBio has the capability to rapidly develop
and manufacture at clinical and commercial scales in its 130,000
square foot facility in Bryan, Texas. Originally built in 2010 with
funding from the U.S. Defense Advanced Research Projects Agency
[DARPA], iBio’s FastPharming Facility® was part of
the “Blue Angel” initiative to establish factories capable of rapid
delivery of medical countermeasures in response to a disease
pandemic.
About iBio, Inc.
iBio is a global leader in plant-based biologics
manufacturing. Its FastPharming System® combines
vertical farming, automated hydroponics, and glycan engineering
technologies to rapidly deliver high-quality monoclonal antibodies,
vaccines, bioinks and other proteins. The Company’s subsidiary,
iBio CDMO LLC, provides FastPharming Contract
Development and Manufacturing Services. iBio’s
FastGlycaneering Development Service™ includes an
array of new glycosylation technologies for engineering
high-performance recombinant proteins. Additionally, iBio is
developing proprietary products, which include IBIO-100 for the
treatment of fibrotic diseases, and vaccines for COVID-19 disease.
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 producing a safe
and effective vaccine for COVID-19 disease and especially one
for our most vulnerable populations, including the elderly, plans
to conduct additional testing of IBIO-201 antisera, including
further evaluations of neutralizing titers in multiple assay
formats, and gaining more insight as we complete data analysis of
both of our COVID-19 vaccine candidates. 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 both SARS-CoV-2 vaccine
candidates, IBIO-201 and IBIO-200, and to produce a safe and
effective vaccine for COVID-19 disease, 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 its product candidates for
specific indications, acceptance of its product candidates in the
marketplace and the successful development, marketing or sale of
products, its ability to maintain its license agreements, the
continued maintenance and growth of its patent estate, its ability
to establish and maintain collaborations, its ability to obtain or
maintain the capital or grants necessary to fund its research and
development activities, competition, or its ability to retain its
key employees and the other factors discussed in the Company’s
Annual Report on Form 10-K for the year ended June 30, 2019 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.
Contacts:
Stephen KilmeriBio, Inc.Investor Relations(646)
274-3580 skilmer@ibioinc.com
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