– Manufacture of the first batch of drug substance under cGMP conditions –
– Analysis of data from the ongoing challenge study –
BRYAN, Texas, Aug. 16, 2022 (GLOBE NEWSWIRE) — iBio, Inc. (NYSEA: IBIO) (“iBio” or the “Company”), a developer of next-generation biopharmaceuticals and pioneer in sustainability FastPharming® Manufacturing System, today provided an update on IBIO-202, its next-generation vaccine candidate under development for multivariate COVID-19 disease.
The Company recently completed its first manufacturing cycle of its proprietary core 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 spike (“S”) protein that mutates frequently – resulting in periods of waning immunity and the spread new variants1 – IBIO-202 uses part of the nucleocapsid (“N”) protein, which is more highly conserved.2 The newly produced antigen N is currently undergoing release testing and if it clears, it is intended for use in clinical studies of IBIO-202.
“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, chief executive officer 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 advanced protein-based COVID-19 vaccines have undoubtedly prevented serious illness and death for millions of people, hospitalizations and deaths have nevertheless recently increased again in the United States.3 This is mainly due to specific mutations in the virus’s spike protein, such as those associated with the BA.5 variant, which cause existing vaccines to offer less protection or shorter periods of immunity.
On July 26 Future of COVID Vaccines Summit, these recent developments prompted Raj Panjabi, MD, MPH, director of the White House Office of Pandemic Preparedness, to state that “predicting where the virus will go is difficult, but so is asking people to get vaccinated two or three times a year. year. It’s a huge challenge. So we need long-lasting vaccines. We need vaccines that provide broader, 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, Senate Appropriations Committee Chairman Patrick Leahy (D-VT), in partnership with the chairs of the subcommittees responsible for national health care and global health, Patty Murray (D-WA) and Chris Coons (D-DE), presented an additional funding bill of $21 billion to provide the resources needed to prepare for the next phase of the COVID-19 pandemic and fight other emerging infectious diseases. This important legislation includes $750 million for next-generation COVID-19 vaccines to protect against worrisome variants of today and tomorrow and underscores the need to sustain and increase domestic manufacturing capacity.
“We continue to engage directly with these members and other members of Congress about funding opportunities for next-generation COVID-19 vaccines,” Isett added. “In addition, we regularly maintain direct dialogue with administration officials about the need and value of funding iBio’s work in this area.”
In addition, iBio has confirmed that it is in the process of compiling and analyzing initial data from IBIO-202’s Enabling New Drug (“IND”) challenge studies.
About iBio’s COVID-19 Vaccine Development Program
In November 2020, iBio began exploring a second-generation N-protein-based COVID-19 vaccine program. In July 2021, iBio announced positive results from variable-dose preclinical studies that demonstrated that IBIO-202 could generate a robust, antigen-specific memory T cell response. Additionally, T-cell priming was achieved by intramuscular and intranasal administration, allowing further exploration of multiple routes of administration and their respective advantages. In September 2021, iBio submitted a pre-IND dossier for IBIO-202 to the FDA. In November 2021, the company announced that it had entered into a collaboration agreement with a leading innovator in the field of microarray patch systems to assess the feasibility of intradermal delivery of a COVID-19 vaccine antigen. Based on comments received from the FDA, in January 2022 iBio announced that it was pursuing IND-Enabling studies for IBIO-202, administered intramuscularly. Today, the company announced that it has completed its first production of its proprietary core antigen under cGMP conditions in support of the production of drug substance IBIO-202. Further information on the COVID-19 vaccination program is available on the Company’s website.
The scientific rationale for 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 several immunogenic epitopes. Second, protein N is more highly conserved than protein S and therefore new variants may be less likely to escape vaccine protection. Third, research has shown that protein N appears to be significantly more effective than protein S in stimulating the activation of antibody-dependent natural killer cells, a critical component of the adaptive immune response that the SARS-CoV-2 virus attempts to mount. ‘to avoid.2,4.5,6,7
1 Goldberg et al. Protection and decline of natural and hybrid COVID-19 immunity.
2 Dutta, NK, Mazumdar, K. & Gordy, JT SARS-CoV-2 nucleocapsid protein: a target for vaccine development. Journal of Virology 94, (2020).
4 Zhao, P. et al. Immune responses against SARS-coronavirus nucleocapsid protein induced by DNA vaccine. Virology 331, 128-135 (2005).
5 Oliveira, SC, de Magalhães, MTQ & Homan, EJ Immunoinformatics analysis of SARS-CoV-2 nucleocapsid protein and identification of COVID-19 vaccine targets. Front. Immunol. 11, (2020).
6 Dai, L. & Gao, GF Viral targets for COVID-19 vaccines. Nature Reviews Immunology 21, 73–82 (2021).
seven 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 spikeless antibodies. bioRxiv, (April 2021).
About iBio, Inc.
iBio is a developer of next-generation biopharmaceuticals and a pioneer in the sustainable manufacturing of plant-based biologics. His FastPharming® The system combines vertical farming, automated hydroponics, and novel glycosylation technologies to rapidly deliver high-quality monoclonal antibodies, vaccines, bioinks, and other proteins. iBio develops exclusive biopharmaceutical products for the treatment of cancers, as well as fibrotic and infectious diseases. The Company’s wholly-owned subsidiary, iBio CDMO LLC, provides FastPharming Development and contract manufacturing services with Glycaner™ Development services for the advanced design of recombinant proteins. For more information, visit www.ibioinc.com.
Certain statements contained in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may”, “could”, “will”, “should”, “believe”, “expect”, “anticipate”, “estimate”, “continue”, “predict”, “plan” , “project”, “” These forward-looking statements are based on 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”, and not a “next dose” of a COVID-19 vaccine; N-, not S-, reactive T cells playing a protective role against SARS-CoV-2 and potentially other betacoronaviruses as well; there is a substantial unmet need for a vaccine that protects against existing – and potentially new – variants and for longer periods; continue to engage directly with these members 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. Although the Company believes that these forward-looking statements are reasonable, undue reliance should not be placed on these forward-looking statements, which are based on information available to the Company as of the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, which could cause actual results to differ materially from current expectations and assumptions than those set forth or implied by the 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 may provide enhanced protection against future variants; iBio’s prospect of securing funding opportunities for next-generation COVID-19 vaccines from Congress; iBio’s ability to obtain regulatory approvals to commercialize IBIO-202 and its other product candidates, or to comply with ongoing regulatory requirements; regulatory limitations on its ability to promote or commercialize its product candidates for specific indications; the market acceptance of its product candidates and the successful development, commercialization or sale of products; and other factors discussed in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2021 and the Company’s subsequent filings with the SEC. 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 as a result of new information, future events or otherwise, except as required by law. .