iBio, Inc., a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, shared an update on its lead COVID-19 vaccine program, IBIO-202.
 
iBio recently received the U.S. FDA response to its pre-investigational new drug (IND) package for IBIO-202 and 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. 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.
 
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.