iBio, Inc. (NYSEA:IBIO), a developer of next-generation biopharmaceuticals and pioneer of the sustainable vertical farming FastPharming® Manufacturing System, provided an update on IBIO-202, its next-generation vaccine candidate under development for multi-variant COVID-19 disease.
The Company recently completed the first manufacturing run of its proprietary nucleocapsid antigen under cGMP conditions using its FastPharming System. Unlike commercially available 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 variants1 -, IBIO-202 uses a portion of the nucleocapsid (“N”) protein, which is more highly conserved.2 The recently produced N antigen 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,” said Tom Isett, Chairman & CEO of iBio. “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. While currently, available spike protein-based COVID-19 vaccines have undoubtedly prevented severe disease and deaths for millions of people, hospitalizations and deaths have nevertheless again been on the rise recently in the U.S.3 This is primarily attributable to mutations specific to the virus’ spike protein, like those associated with the BA.5 variant, that results in existing vaccines providing less protection or shorter periods of immunity.”
During the July 26 Summit on the Future of COVID Vaccines, these recent developments prompted Raj Panjabi, MD, MPH, Director of the White House Pandemic Preparedness Office, to state that, “Predicting where the virus is going to go is hard, but so is asking people to get vaccinated two or three times a year. That is a huge challenge. So, we need vaccines that are durable. We need vaccines that offer broader and longer lasting protection. We need vaccines that offer protection against multiple variants. Ultimately, we need vaccines that can protect us no matter what mother nature throws at us.”3
Last month, Chair of the Senate Appropriations Committee, Patrick Leahy (D-VT), in partnership with the Subcommittee Chairs responsible for domestic health care and global health, 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. This important legislation incudes $750 million for next-generation COVID-19 vaccines to protect against variants of concern for today and tomorrow 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,” added Mr. Isett. “In addition, we regularly maintain direct dialogue with Administration officials on the need for, and value of, funding iBio’s work in this field.”
Additionally, iBio confirmed it is currently compiling and analyzing initial data from investigational new drug (“IND”)-Enabling challenge studies of IBIO-202.