- 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 -
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
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