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.
- Price Action: IBIO shares are down 1.29% at $0.47 during the market session on the last check Wednesday.
