iBio Announces Second COVID-19 Vaccine Program
June 04 2020 - 7:00AM
iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”), a
biotechnology innovator and biologics contract manufacturing
organization, today announced initiation of preclinical
immunization studies for its second COVID-19 vaccine platform.
The new subunit vaccine (“IBIO-201”) combines
antigens derived from the SARS-CoV-2 spike protein fused with the
Company’s patented lichenase booster molecule (“LicKM”), which is
designed to enhance immune response. The addition of the LicKM
booster to a subunit antigen is expected to improve the likelihood
of achieving single-dose, prolonged immunity while also increasing
manufacturing capacity through increased potency.
“The launch of our second COVID-19 vaccine
program is emblematic of the speed, flexibility and scalability we
can achieve by combining our plant-based
FastPharming System™ with other technologies in
our intellectual property portfolio, such as LicKM,” said Tom
Isett, Co-Chairman & CEO of iBio. “As a company with
purpose-built pandemic response capabilities, we are pleased that
in a matter of weeks we successfully discovered and advanced two
promising, unique, internally-developed, COVID-19 vaccine programs
into IND-enabling studies. Equally important is that our
plant-based system avoids resource-intensive scale-up challenges
associated with traditional manufacturing approaches so that we
should be able to more rapidly produce high-quality material for
hundreds of millions of doses upon regulatory clearance.”
Based on extensive research, iBio believes that
the lichenase thermostable immunomodulator protein technology has
the potential to increase both the potency of subunit vaccines as
well as the durability of the immune response. Previously published
peer-reviewed laboratory data demonstrated that an iBio
lichenase-based vaccine candidate provided full protection against
aerosolized pneumonic plague in non-human primates. In addition,
published data have demonstrated the value of the lichenase
technology in vaccine candidate applications targeting both anthrax
and yellow fever virus.
“One of the common challenges with soluble
antigens is that they often require the use of an adjuvant to boost
their immunogenicity,” commented Dr. Sylvain Marcel, iBio’s VP of
Protein Expression Sciences. “Our LicKM technology has the
potential to achieve the same immune response as a soluble antigen
vaccine approach, but with lower vaccine antigen requirements. This
may prove to be valuable in reducing the number of vaccine doses
necessary to establish prolonged immunity.”
Along with the Company’s previously announced
virus-like particle (“VLP”) vaccine candidate (“IBIO-200”), the
LicKM-Subunit vaccine will be tested at Texas A&M University
System (“TAMUS”) laboratories as part of the Master Joint
Development Agreement established between iBio and TAMUS in 2016,
as well as a Memorandum of Understanding entered into between iBio
and Infectious Disease Research Institute (“IDRI”) in April 2020.
The Company’s decision to exercise its option to include one of
IDRI’s novel adjuvants in any COVID-19 vaccine programs will be
made within 60 days of completion of the immunization studies.
About iBio’s COVID-19 Vaccine
Development Program
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 the addition of the
LicKM booster to a subunit antigen improving the likelihood of
achieving single-dose, prolonged immunity while also increasing
manufacturing capacity through increased potency, being able to
more rapidly produce high-quality material for hundreds of millions
of doses upon regulatory clearance and lichenase thermostable
immunomodulator protein technology having the potential to increase
both the potency of subunit vaccines as well as the durability of
the immune response and the Company’s LicKM technology
proving to be valuable in reducing the number of vaccine doses
necessary to establish prolonged immunity. 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 more
rapidly produce high-quality material for hundreds of millions of
doses upon regulatory clearance, the ability of lichenase
thermostable immunomodulator protein technology to increase both
the potency of subunit vaccines as well as the durability of the
immune response, the ability to reduce the number of vaccine doses
necessary to establish prolonged immunity, the Company’s ability to
obtain regulatory approvals for commercialization of its product
candidates 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, its ability to retain its key employees or maintain
its NYSE American listing. 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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