Advertisement
Inovio Pharma Receives FDA Feedback On Submission Of BLA For INO-3107 To Treat RRP
(RTTNews) - 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.
For More Such Health News, visit rttnews.com
INOVIO Says FDA Grants Breakthrough Therapy Designation For INO-3107; Stock Up 15%
INOVIO Pharma Announces Positive Results From Phase 1b Clinical Trial Evaluating INO-4201
INOVIO Reports Positive Interim Phase 1/2 Trial Results For INO-3107 For Respiratory Papillomatosis
INOVIO Announces Corporate Reorganization, Including Workforce Reduction, To Reduce Expenses
European Shares Seen Higher At Open
NZ Dollar Rises Against Majors
Sensex, Nifty Edge Lower On Tariff Concerns
