iBio to Advance COVID-19 LicKM-Subunit Vaccine Candidate, IBIO-201
September 09 2020 - 8:45AM
iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”), a
biotech innovator and biologics contract manufacturing
organization, today announced that it has selected IBIO-201, its
LicKM™-ubunit vaccine, as its leading candidate
for the prevention of SARS-CoV-2 infection.
iBio previously announced that preclinical
immunization studies with IBIO-200 and IBIO-201, combined with
select adjuvants from the Infectious Disease Research Institute
(“IDRI”), induced anti-SARS-CoV-2 antibodies. Additional data from
cell-based pseudovirus neutralization assay testing demonstrate
that IBIO-201 induced the production of more anti-spike
neutralizing antibodies than IBIO-200 in immunized mice.
“Our decision to evaluate IBIO-200 and IBIO-201
in tandem, and in combination with multiple adjuvants, proved
beneficial given the results observed with IBIO-201 in preclinical
studies,” said Tom Isett, Chairman & CEO of iBio. “While
IBIO-201 produced significantly higher anti-spike neutralizing
antibody titers than IBIO-200, we are still encouraged by the
potential of IBIO-200.”
Mr. Isett continued, “We plan to conduct more
focused studies on each of IBIO-200 and IBIO-201, with the goal of
advancing IBIO-201 to toxicology studies ahead of planned clinical
development. Meanwhile, we intend to continue preclinical
development of IBIO-200 and our virus-like particle platform as a
potential ‘plug-and-play’ vaccine development system.”
iBio continues to work with IDRI and the Texas
A&M University System, and expects to engage additional
collaborators for further characterization and testing of IBIO-201
prior to performing GLP toxicology studies.
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 Company
subsequently announced its virus-like particle (“VLP”) program
(“IBIO-200”) and LicKM™-Subunit vaccine program
(“IBIO-201”) on March 18, and June 3, 2020, respectively, and
pre-clinical studies were subsequently initiated. On August 27,
2020, the Company secured exclusive worldwide rights to an ACE2-Fc
antibody therapeutic. On September 9, 2020, iBio announced that it
intended to advance IBIO-201 while it continued to evaluate
IBIO-200. If any of the COVID-19 biopharmaceutical development
program(s) move into clinical trials, iBio has the capability to
manufacture product candidates 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 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, as well as vaccines and
therapeutics for COVID-19 disease. 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-200, plans to conduct more focused studies on each of IBIO-200
and IBIO-201, with the goal of advancing IBIO-201 to toxicology
studies, continuing preclinical development of IBIO-200 and our
virus-like particle platform as a potential ‘plug-and-play’ vaccine
development system, continuing work with IDRI and the Texas A&M
University System, and expected engagement of additional
collaborators for further characterization and testing of IBIO-201
prior to performing GLP toxicology studies. 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-201 and
IBIO-200, and to develop and commercialize a 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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