iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a developer of
next-generation biopharmaceuticals and pioneer of the sustainable
FastPharming Manufacturing System®, today shared
an update on its lead COVID-19 vaccine program, IBIO-202.
iBio recently received the U.S. Food and Drug
Administration’s (“FDA”) response to its pre-investigational new
drug (“IND”) package for IBIO-202. In light of the feedback
received, the Company is moving forward with IND-enabling challenge
studies for its second-generation vaccine candidate targeting the
nucleocapsid (“N”) protein and plans to file an IND application
before the end of calendar 2022.
Commercially available first-generation vaccines
target the frequently mutating spike ("S") protein, resulting in
waning periods of immunity and the spread of new
variants.1 These developments have prompted the World
Health Organization to state that, “a vaccination strategy based on
repeated booster doses of the original vaccine composition is
unlikely to be appropriate or sustainable.”2 Meanwhile, evidence
continues to emerge that “N-, not S-, reactive T cells appear to
play a protective role” for SARS-CoV-2 and potentially other
betacoronaviruses as well.3
“Science is showing us that real-world vaccine
effectiveness has diminishing returns with an overreliance on
S-based vaccines,” said Tom Isett, Chairman & Chief Executive
Officer of iBio. “Several studies have demonstrated that the N
protein appears to be more effective than the S protein towards
stimulating a durable immune response. Obviously, the emergence of
variants like Omicron underscores how mutations to the S protein
can enable the virus to spread and sicken millions of people,
despite steadily increasing immunization rates. So, we intend to
move forward quickly with our IND-enabling studies and be in
position to file an IND application for IBIO-202 as soon as
possible.”
The Company previously reported that it had
completed extensive preclinical studies and identified an
antigen-adjuvant pairing with a favorable Th1 skew. The cytokine
response observed with this pairing indicated activation of a
primary immune response, differentiation of mature T cells, and
reactivation of memory T-cells.
“We selected a highly conserved region of the N
protein and used advanced epitope design techniques to create
IBIO-202,” said Martin Brenner, DVM. Ph.D., iBio’s Chief Scientific
Officer. “We believe the data suggests this candidate has the
potential to address many of the unmet needs that remain in the
fight against COVID, a pandemic which may very well continue to
wreak havoc if we continue to focus only on S-based vaccines. We
need to work towards a ‘last dose’, not a ‘next dose’.”
About iBio’s COVID-19 Vaccine
Development Program
In November 2020, iBio began 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 FDA. In November 2021, the Company announced that it entered a
collaboration agreement with a leading innovator of microarray
patch systems, which are a painless alternative to intramuscular
injections, to evaluate feasibility of intradermal delivery of a
COVID-19 vaccine antigen. Today, iBio announced that, based on
feedback it has received from the FDA, it will pursue IND-enabling
studies for IBIO-202. 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 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.4,5,6,7,8
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
https://www.who.int/news/item/11-01-2022-interim-statement-on-covid-19-vaccines-in-the-context-of-the-circulation-of-the-omicron-sars-cov-2-variant-from-the-who-technical-advisory-group-on-covid-19-vaccine-composition
3 Kundu, R., Narean, J.S., Wang, L. et
al. Cross-reactive memory T cells associate with protection
against SARS-CoV-2 infection in COVID-19 contacts. Nat
Commun 13, 80 (2022)
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 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).
7 Dai, L. & Gao, G. F. Viral targets for vaccines against
COVID-19. Nature Reviews Immunology 21, 73–82 (2021).
8 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 filing an IND application for
IBIO-202 before the end of calendar 2022; the intent to move
forward quickly with IND-enabling studies and be in position to
file an IND application for IBIO-202 as soon as possible; N-, not
S-, reactive T cells playing a protective role for SARS-CoV-2 and
potentially other betacoronaviruses as well; IBIO-202 having the
potential to address many of the unmet needs that remain in the
fight against COVID, a pandemic which may very well continue to
wreak havoc if we continue to focus only on S-based 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 better
protection against future variants; 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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