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

RTTNews | vor 644 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.

read more
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.
RTTNews | vor 611 Tagen
U.S. Weekly Jobless Claims Unexpectedly Unchanged At Eight-Month High

U.S. Weekly Jobless Claims Unexpectedly Unchanged At Eight-Month High

The Labor Department released a report on Thursday showing first-time claims for U.S. unemployment benefits came in flat in the week ended June 7th. The report said initial jobless claims in at 248,000, unchanged from the previous week's revised level. Economists had expected jobless claims to dip to 240,000 from the 247,000 originally reported for the previous week.
RTTNews | vor 2 Minuten
Bay Street Likely To Open On Negative Note

Bay Street Likely To Open On Negative Note

Canadian shares are likely to open with a negative bias on Thursday as trade concerns, and Middle East tensions may weigh on sentiment. A lack of specifics in the framework agreed to by U.S. and Chinese officials on Tuesday has raised uncertainty about the two nations reaching an agreement anytime soon.
RTTNews | vor 45 Minuten
U.S. Producer Prices Inch Up Less Than Expected In May

U.S. Producer Prices Inch Up Less Than Expected In May

After reporting an unexpected decrease by U.S. producer prices in the previous month, the Labor Department released a report Thursday showing producer prices crept slightly higher in the month of May.
RTTNews | vor 1Std 11 Minuten