Inovio’s Phase II/III COVID-19 vaccine study delayed pending resolution of partial hold, funding
FDA’s partial hold on Inovio’s planned Phase II/III COVID-19 vaccine trial comes as the company is seeking additional funding to support the study.
Inovio Pharmaceuticals Inc. (NASDAQ:INO) fell $4.80 (28%) to $12.14 Monday, losing $804 million in market value, after revealing that FDA has additional questions regarding the planned trial of INO-4800 and its Cellectra device for delivering the DNA vaccine.
An Inovio representative told BioCentury FDA asked about the “use of INO-4800” in the Phase II/III trial, but did not provide additional details about the agency’s concerns. The trial has not yet begun enrollment.
The company plans to respond to FDA in October, after which the agency will have 30 days to decide whether to lift the hold. Inovio is continuing to prepare for the study, pending resolution of the partial hold and receipt of new funds to run the trial.
Inovio had previously predicted a July or August start for its Phase II/III study; in August, the company revised its guidance for September.
Inovio was one of the first companies to announce a COVID-19 vaccine program. In January, the company received a grant from Coalition for Epidemic Preparedness Innovations (CEPI) for up to $9 million to fund Phase I testing of INO-4800, and in April, CEPI granted the biotech and its partners an additional $8.2 million to support manufacturing and clinical trials (see “Biopharma Racing”).
However, the company has not received financial support for clinical trials or manufacturing through Operation Warp Speed.
An August New England Journal of Medicine perspective co-penned by that initiative’s Chief Scientific Adviser Moncef Slaoui, which laid out the criteria for Operation Warp Speed vaccine candidates, suggests that INO-4800 has been excluded because of its modality. The article stated that candidates had to use one of four platforms: mRNA, replication-deficient live vectors, adjuvanted recombinant subunit proteins or attenuated replicating live vectors.
Despite its lack of Operation Warp Speed funding, Inovio has said the initiative selected INO-4800 for inclusion in a non-human primate study. The company has also received financial support from the U.S. government.
In March, the Department of Defense awarded Inovio and one of its CDMO partners, Ology Bioservices Inc., a contract for up $11.9 million to manufacture INO-4800 for clinical trials. DoD also awarded Inovio a $71 million contract in June to procure the intradermal Cellectra 2000 devices and scale up production of the biotech’s Cellectra 3PSP vaccine delivery device.
Prior to COVID-19, Defense Research Advanced Projects Agency (DARPA) had supported Inovio’s early R&D at a time when many scientists and investors considered its DNA-encoded vaccine and therapeutics platform speculative (see “DARPA’s Gambles”).