iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a developer of
next-generation biopharmaceuticals and pioneer of the sustainable
FastPharming Manufacturing System®, today
announced an update for its lead COVID-19 vaccine program,
IBIO-202, in light of the emergence of the Omicron (B.1.1.529)
variant of SARS-CoV-2.
On November 26, 2021, the World Health
Organization’s (“WHO”) Technical Advisory Group on SARS-CoV-2 Virus
Evolution classified Omicron as a Variant of Concern.1 According to
the WHO, the Omicron variant has at least 30 mutations in the spike
("S") protein, which has been the target of first-generation
COVID-19 vaccines.
“It is becoming increasingly likely that new
COVID-19 vaccines will be needed to address the growing threats to
global public health from SARS-CoV-2 variants such as Omicron,”
said Tom Isett, Chairman & Chief Executive Officer of iBio.
“The emergence of Omicron has strengthened our belief that a
next-generation vaccine development strategy such as iBio’s, which
targets the genetically more conserved nucleocapsid, or N, protein
rather than the mutable S protein, is needed to help overcome this
pandemic. Based on the sequencing data posted on Nextstrain,
Omicron’s mutations do not occur in the region selected for our
IBIO-202 N protein subunit vaccine candidate, as was the case with
previous variants. We are looking forward to productive
interactions with regulators and other groups concerned with what
may be an overreliance on S protein-directed vaccines.”
The Company believes that the N protein
represents an important target for next-generation COVID-19
vaccines for several reasons. First, the N protein is abundantly
expressed during infection and contains multiple immunogenic
epitopes. Second, the N protein is more highly conserved than the S
protein, and therefore, new variants may be less likely to escape
vaccine protection. Third, research has shown that the N protein
appears to be significantly more effective than the S protein in
stimulating antibody-dependent natural killer cell activation, a
critical element of the adaptive immune response that the
SARS-CoV-2 virus attempts to evade.2,3,4,5,6
“The IBIO-202 program represents innovation
across multiple fronts,” said Martin Brenner, DVM, Ph.D., iBio’s
Chief Scientific Officer. “We are developing our COVID vaccine
candidate in line with an approach we call our
‘DAVi’ strategy, which stands for improved
Durability, Access and
Variant-inclusion. We believe
IBIO-202 may afford greater durability given the novel antigen and
adjuvant combination we have identified. We also seek to improve
patient access by avoiding distribution challenges for frozen
products that a number of first-generation vaccines require, and we
may ultimately be able to improve access by exploring more
convenient alternatives to intramuscular injections, such as
intradermal delivery via a microarray patch. Finally, we expect an
N-based vaccine to provide better protection against future
variants, given how mutable the S protein appears to be.”
As discussed in the Company’s recent Q1-FY2022
conference call, iBio filed a pre-IND application for IBIO-202 with
the U.S. Food and Drug Administration in September. A response from
the Agency is expected before the end of January.”
References
1
https://www.who.int/news/item/26-11-2021-classification-of-omicron-(b.1.1.529)-sars-cov-2-variant-of-concern
2 Zhao, P. et al. Immune responses against
SARS-coronavirus nucleocapsid protein induced by DNA vaccine.
Virology 331, 128–135 (2005).
3 Oliveira, S. C., de Magalhães, M. T. Q. &
Homan, E. J. Immunoinformatic Analysis of SARS-CoV-2 Nucleocapsid
Protein and Identification of COVID-19 Vaccine Targets. Front.
Immunol. 11, (2020).
4 Dutta, N. K., Mazumdar, K. & Gordy, J. T.
The Nucleocapsid Protein of SARS–CoV-2: A Target for Vaccine
Development. Journal of Virology 94, (2020).
5 Dai, L. & Gao, G. F. Viral targets for
vaccines against COVID-19. Nature Reviews Immunology 21, 73–82
(2021).
6 Fielding CA, Sabberwal P, Williamson JC,
Greenwood EJD, Crozier TWM, Zelek W, Seow J, Graham C, Huettner I,
Edgeworth JD, Morgan BP, Ladell K, Eberl M, Humphreys IR, Merrick
B, Doores K, Wilson SJ Lehner PJ, Wang ECY, Stanton RJ. ADNKA
overcomes SARS-CoV2-mediated NK cell inhibition through non-spike
antibodies. bioRxiv, (April 2021).
About iBio’s COVID-19 Vaccine
Development Program
In November 2020, iBio made the decision to
begin exploring a second-generation COVID vaccine program based
upon the nucleocapsid protein. In July 2021, iBio announced
positive results from dose-ranging, preclinical studies that
demonstrated IBIO-202 could generate a robust, antigen-specific,
memory T-cell 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. In September 2021, iBio submitted a
pre-IND package for IBIO-202 to the U.S. Food and Drug
Administration. On November 19, 2021, the Company announced that it
had entered into a collaboration with a leading innovator of
microarray patch systems, which are a painless alternative to
intramuscular injections. The first objective of the collaboration
is to evaluate feasibility of intradermal delivery of a COVID-19
vaccine antigen. More information on the IBIO-202 program can be
found on the Company’s website.
About iBio, Inc.
iBio is a developer of next-generation
biopharmaceuticals and a pioneer in sustainable, 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 biopharmaceuticals for the treatment of
cancers, as well as fibrotic and infectious diseases. The Company’s
wholly-owned 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 a next-generation
vaccine development strategy such as iBio’s, which targets the
genetically more conserved nucleocapsid, or N, protein rather than
the mutable S protein, being needed to help overcome the pandemic,
the N protein representing an important target for next-generation
COVID-19 vaccines, IBIO-202 affording greater durability given the
novel antigen and adjuvant combination iBio has identified,
improving patient access by avoiding distribution challenges for
frozen products that a number of first-generation vaccines require,
and improving access by exploring more convenient alternatives to
intramuscular injections, such as intradermal delivery via a
microarray patch, an N-based vaccine providing better protection
against future variants, and iBio receiving a response from the
U.S. Food and Drug Administration regarding iBio’s pre-IND
application for IBIO-202 before the end of January. 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 the Company
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 develop IBIO-202 as a vaccine that can provide
better protection against future variants, have greater durability
given the novel antigen and adjuvant combination iBio has
identified, and improve patient access by avoiding distribution
challenges for frozen products that a number of first-generation
vaccines require, iBio’s ability to obtain regulatory approvals for
commercialization of IBIO-202 and its other 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, and the other factors
discussed in the Company’s filings with the SEC including the
Company’s Annual Report on Form 10-K for the year ended June 30,
2021 and the Company’s subsequent filings with the SEC on Forms
10-Q and 8-K. The information in this release is provided only as
of the date of this release, and the Company undertakes 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)
274-3580skilmer@ibioinc.com
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