Biotechnology company Inovio Pharmaceuticals, Inc. (INO) announced Tuesday that it has received feedback from the U.S. Food and Drug Administration (FDA) that data from its completed Phase 1/2 trial of INO-3107 for the treatment of RRP could support INOVIO's submission of a BLA for review under the FDA's accelerated approval program.
The FDA also advised that the company's previously planned Phase 3 randomized, placebo-controlled trial would not be required to support this submission.
INOVIO will be required to initiate a confirmatory trial prior to BLA submission for accelerated approval and satisfy all other FDA filing requirements.
If approved, INO-3107 would be the first DNA medicine in the U.S. and the first INOVIO candidate to receive regulatory approval.
INOVIO's completed Phase 1/2 open-label, multicenter trial assessed INO-3107's safety, tolerability, immunogenicity, and efficacy in patients with HPV-6 and/or HPV-11-related RRP. The trial evaluated the reduction in the number of surgical interventions in the year following initial administration of INO-3107 compared to the year prior to treatment.
INO-3107 is INOVIO's lead candidate and one of three clinical-stage DNA medicine candidates targeting HPV-related disease.
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