iBio (NYSEA:IBIO) provided an update on IBIO-202, its next-generation vaccine candidate under development for multi-variant COVID-19 disease.
Unlike first-generation COVID vaccines that seek to provide immunity by presenting an antigen based on the frequently mutating spike (S) protein, which results in waning periods of immunity and the spread of new variants, IBIO-202 uses a portion of the nucleocapsid (N) protein, which is more highly conserved.
iBio recently completed its first manufacturing run of its proprietary nucleocapsid antigen under cGMP conditions using its FastPharming System. The batch is currently undergoing release testing and, if it clears, is intended for use in IBIO-202 clinical studies.
“This is another important step in our mission to develop a ‘last dose,’ not a ‘next dose,’ of a COVID-19 vaccine,” Tom Isett, chairman and CEO of iBio, said in a statement. “We believe there is a substantial unmet need for a vaccine that protects against existing – and potentially new – variants and for longer periods of time.”
Mr. Isett was responding to a July 26 Summit on the Future of COVID Vaccines, where the director of the White House Pandemic Preparedness Office said the U.S. needs vaccines that offer protection against multiple variants and protect people “no matter what Mother Nature throws at us.”
While currently available spike protein-based COVID-19 vaccines have prevented severe disease and deaths for millions of people, Mr. Isett said hospitalizations and deaths are again rising in the U.S. “This is primarily attributable to mutations specific to the virus’ spike protein, like those associated with the BA.5 variant, that result in existing vaccines providing less protection or shorter periods of immunity,” he added.
Last month, chair of the Senate Appropriations Committee, Patrick Leahy (D-VT), in partnership with the Subcommittee chairs, Patty Murray (D-WA) and Chris Coons (D-DE), introduced a $21-billion supplemental funding bill to provide necessary resources to prepare for the next phase of the COVID-19 pandemic and address other emerging infectious diseases.
The proposed legislation incudes $750-million for next generation COVID-19 vaccines to protect against variants and emphasizes the need to support, and increase, domestic manufacturing capacity.
“We continue to engage directly with these and other members of Congress on funding opportunities for next-generation COVID-19 vaccines,” Mr. Isett said. “In addition, we regularly maintain direct dialogue with Administration officials on the need for, and value of, funding iBio’s work in this field.”
iBio also confirmed that it is currently compiling and analyzing initial data from IND-enabling challenge studies of IBIO-202, delivered intramuscularly.
iBio believes 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 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.