Full Press Release Details
iBio Reports Successful
Preclinical Immunization Studies with Next-Gen Nucleocapsid COVID-19 Vaccine Candidate
Bryan, TX / July 15, 2021 / (GLOBE NEWSWIRE)
/ 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
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.