iBio Inc (NYSE: IBIO) received the FDA response to its pre-investigational new drug (IND) package for IBIO-202, the Company's lead COVID-19 vaccine program.
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.
It plans to file an IND application before the end of calendar 2022.
The Company previously reported completing extensive preclinical studies and identifying an antigen-adjuvant pairing with a favorable Th1 skew.
The cytokine response observed with this pairing indicated a primary immune response, differentiation of mature T cells, and reactivation of memory T-cells.
In September 2021, iBio submitted a pre-IND package for IBIO-202 to the FDA.
In November 2021, the Company entered a collaboration agreement with a provider of microarray patch systems to evaluate the feasibility of intradermal delivery of a COVID-19 vaccine antigen.
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