Inovio Pharma Receives FDA Feedback On Submission Of BLA For INO-3107 To Treat RRP

RTTNews | 611 dagar sedan
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

read more
Yen Rises Against Most Majors

Yen Rises Against Most Majors

The Japanese yen strengthened against most major currencies in the Asian session on Friday.
RTTNews | 53 minuter sedan
European Shares Set For Gap-down Open

European Shares Set For Gap-down Open

European shares are seen opening sharply lower on Friday as trade uncertainties and escalating geopolitical tensions sparked flight to safety.
RTTNews | 1h 33minuter sedan