INOVIO Says FDA Grants Breakthrough Therapy Designation For INO-3107; Stock Up 15%

RTTNews | vor 645 Tagen
INOVIO Says FDA Grants Breakthrough Therapy Designation For INO-3107; Stock Up 15%

(RTTNews) - Biotechnology company Inovio Pharmaceuticals, Inc. (INO) announced Thursday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for INO-3107 as a potential treatment for patients with Recurrent Respiratory Papillomatosis (RRP).

The FDA's Breakthrough Therapy designation is a process designed to expedite the development and review of drug candidates that are intended to treat a serious or life-threatening condition.

INO-3107 is an investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types that cause RRP and other HPV-related disease.

This Breakthrough Therapy designation for INO-3107 follows receipt of Orphan Drug designation from the European Commission in May 2023 and from the FDA in 2020.

INOVIO plans to initiate a pivotal trial of INO-3107 in the first quarter of 2024, subject to FDA clearance.

The Breakthrough Therapy designation is supported by data from INOVIO's completed Phase 1/2 open-label, multicenter trial that assessed INO-3107's safety, tolerability, immunogenicity, and efficacy in patients with HPV-6 and/or HPV-11-related RRP (NCT:04398433).

Overall, 81.3% patients in the trial had a decrease in surgical interventions in the year after INO-3107 administration compared to the prior year, including 28.1% that required no surgical intervention during or after the dosing window.

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

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

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.
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