Type: Subunit vaccine candidate targeting the nucleocapsid protein (N protein) of SARS-CoV-2.
2022 Status: IND-Enabling Studies–iBio said January 26 that it was moving ahead with IND-enabling challenge studies IBIO-202 and plans to file an IND application before the end of 2022, after receiving a response from the FDA to its pre-IND package.
2021 Status: Presenting the Case vs. Omicron–iBio said November 29 that its vaccine development strategy, which targets the genetically more conserved nucleocapsid or N protein rather than the mutable S protein, can succeed vs. the Omicron variant (B.1.1.529) of SARS-CoV-2, since Omicron’s mutations do not occur in the region selected for IBIO-202, 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.” added Tom Isett, iBio’s Chairman and CEO.
According to iBio, the N protein represents an important target for next-generation COVID-19 vaccines because the N protein is abundantly expressed during infection and contains multiple immunogenic epitopes; the N protein is more highly conserved than the S protein, thus new variants may be less likely to escape vaccine protection; and because 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 key element of the adaptive immune response that the SARS-CoV-2 virus attempts to evade.
Focusing on IBIO-202–iBio on May 6 disclosed the development of IBIO-202. “In light of the successful global roll-out of COVID-19 vaccines targeting the S protein and the emergence of variant strains of the disease, we decided to focus our efforts on the continued development of IBIO-202 as a differentiated vaccine candidate,” stated Tom Isett, iBio’s chairman and CEO.
The company reasons that N proteins of many coronaviruses are highly immunogenic and are expressed abundantly during infection—and that as the N protein is more highly conserved than the S protein, new viral variants may be less likely to escape vaccine protection.
Using its plant-based FastPharming® manufacturing system, iBio said, it has successfully expressed N protein antigens and initiated both intramuscular and intranasal preclinical studies to identify favorable antigen-adjuvant combinations. Results are expected in early Q1 FY2022.
“The N protein strategy of IBIO-202 is complementary to existing first-generation, S protein-directed vaccines and may be suitable as a more universal coronavirus vaccine,” added Martin Brenner, PhD, iBio’s CSO.
iBio said it recently filed four provisional patent applications with the U.S. Patent and Trademark Office in support of the IBIO-202 program.
In parallel with the development of IBIO-202, iBio said, it continues to evaluate the potential of a multi-subunit vaccine candidate to further increase vaccine protection from variants by targeting two or more important elements of SARS-CoV-2.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: