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Omicron Variant Underscores Need for New COVID Vaccine Candidates Like IBIO-202

November 29, 2021

– Global Reliance on Spike Protein-Based Vaccines May Create Public Health Risks –

– Omicron’s Many Mutations Occur in Regions Outside Those of IBIO-202’s Nucleocapsid Antigen –

– Company Expecting Feedback from U.S. FDA on IBIO-202 in January –

BRYAN, Texas, Nov. 29, 2021 (GLOBE NEWSWIRE) — 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 Kilmer
iBio, Inc.
Investor Relations
(646) 274-3580
skilmer@ibioinc.com

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