iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a developer of
next-generation biopharmaceuticals and pioneer of the sustainable
FastPharming® Manufacturing System, today provided
an update on IBIO-202, its next-generation vaccine candidate under
development for multi-variant COVID-19 disease.
The Company recently completed its first
manufacturing run of its proprietary nucleocapsid antigen under
cGMP conditions using its FastPharming System.
Unlike commercially available first-generation COVID vaccines that
seek to provide immunity by presenting an antigen based on the
frequently mutating spike ("S") protein - which results in waning
periods of immunity and the spread of new variants1 - IBIO-202 uses
a portion of the nucleocapsid (“N”) protein, which is more highly
conserved.2 The recently produced N antigen is currently undergoing
release testing and, if it clears, is intended for use in IBIO-202
clinical studies.
“This is another important step in our mission
to develop a ‘last dose’, not a ‘next dose’ of a COVID-19 vaccine,”
said Tom Isett, Chairman & CEO of iBio. “We believe there is a
substantial unmet need for a vaccine that protects against existing
- and potentially new - variants and for longer periods of time.
While currently available spike protein-based COVID-19 vaccines
have undoubtedly prevented severe disease and deaths for millions
of people, hospitalizations and deaths have nevertheless again been
on the rise recently in the U.S.3 This is primarily attributable to
mutations specific to the virus’ spike protein, like those
associated with the BA.5 variant, that result in existing vaccines
providing less protection or shorter periods of immunity.”
During the July 26 Summit on the Future of COVID
Vaccines, these recent developments prompted Raj Panjabi, MD, MPH,
Director of the White House Pandemic Preparedness Office, to state
that, “Predicting where the virus is going to go is hard, but so is
asking people to get vaccinated two or three times a year. That is
a huge challenge. So, we need vaccines that are durable. We need
vaccines that offer broader and longer lasting protection. We need
vaccines that offer protection against multiple variants.
Ultimately, we need vaccines that can protect us no matter what
mother nature throws at us."3
Last month, Chair of the Senate Appropriations
Committee, Patrick Leahy (D-VT), in partnership with the
Subcommittee Chairs responsible for domestic health care and global
health, Patty Murray (D-WA) and Chris Coons (D-DE), introduced a
$21 billion supplemental funding bill to provide necessary
resources to prepare for the next phase of the COVID-19 pandemic
and address other emerging infectious diseases. This important
legislation incudes $750 million for next-generation COVID-19
vaccines to protect against variants of concern for today and
tomorrow and emphasizes the need to support, and increase, domestic
manufacturing capacity.
“We continue to engage directly with these and
other Members of Congress on funding opportunities for
next-generation COVID-19 vaccines,” added Mr. Isett. “In addition,
we regularly maintain direct dialogue with Administration officials
on the need for, and value of, funding iBio’s work in this
field.”
Additionally, iBio confirmed it is currently
compiling and analyzing initial data from investigational new drug
(“IND”)-Enabling challenge studies of IBIO-202.
About iBio’s COVID-19 Vaccine
Development Program
In November 2020, iBio began exploring a
second-generation COVID-19 vaccine program based on the N 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 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 FDA. In
November 2021, the Company announced it entered into a
collaboration agreement with a leading innovator of microarray
patch systems in order to evaluate feasibility of intradermal
delivery of a COVID-19 vaccine antigen. Based on feedback it
received from the FDA, in January 2022, iBio announced it was
pursuing IND-Enabling studies for IBIO-202, delivered
intramuscularly. Today, the Company announced it completed its
first manufacturing run of its proprietary nucleocapsid antigen
under cGMP conditions in support of IBIO-202 drug substance
production. More information on the COVID-19 vaccine program can be
found on the Company’s website.
The Scientific Rationale Behind
Targeting the N Protein of SARS-CoV-2
iBio believes 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 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.2,4,5,6,7
References
1 Goldberg, et al. Protection and waning of natural and hybrid
COVID-19 immunity.
https://www.medrxiv.org/content/10.1101/2021.12.04.21267114v1
2 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).
3
https://bestlifeonline.com/fauci-covid-vaccines-next-generation-news/
4 Zhao, P. et al. Immune responses against SARS-coronavirus
nucleocapsid protein induced by DNA vaccine. Virology 331, 128–135
(2005).
5 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).
6 Dai, L. & Gao, G. F. Viral targets for vaccines against
COVID-19. Nature Reviews Immunology 21, 73–82 (2021).
7 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, 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 the Company’s mission to
develop a ‘last dose’, not a ‘next dose’ of a COVID-19 vaccine; N-,
not S-, reactive T cells playing a protective role for SARS-CoV-2
and potentially other betacoronaviruses as well; there being a
substantial unmet need for a vaccine that protects against existing
- and potentially new - variants and for longer periods of time;
continuing to engage directly with these and other Members of
Congress on funding opportunities for next-generation COVID-19
vaccines; and the N protein representing an important target for
next-generation COVID-19 vaccines for several reasons. 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; iBio’s prospect to
secure funding opportunities for next-generation COVID-19 vaccines
from Congress; 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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