Inovio slapped with FDA PhIII clinical hold, shares tumble


Inovio Pharmaceuticals ($INO) has been stopped before it started as its planned Phase III trial of an experimental therapy designed to eliminate precancerous cervical lesions was halted this morning by the FDA.

In a brief update, Inovio said the U.S. regulator “has placed a clinical hold on its proposed Phase III clinical program for VGX-3100,” with the FDA apparently concerned about the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device.

It wants additional data to support the trial, according to a statement from the biotech, which Inovio believes will push back the start of the late-stage test into the first half of next year.

Virtual Roundtable

ESMO Post Show: Highlights From the Virtual Conference

Cancer experts and pharma execs will break down the headline-making data from ESMO, sharing their insights and analysis around the conference’s most closely watched studies. This discussion will examine how groundbreaking research unveiled over the weekend will change clinical practice and prime drugs for key new indications, and panelists will fill you in on the need-to-know takeaways from oncology’s hottest fields.

“Inovio is working diligently with the FDA to address its concerns and anticipates that the requested data will be available before the end of this year,” the company said in a statement.

Back in 2014, the biotech released data showing its experimental med had hit its primary endpoint, but the tests have proven controversial with some, such as the TheStreet’s Adam Feuerstein, saying it had only won out by spinning the data.

Time has not dampened his feelings on the drug, saying today on Twitter: “INO--great work once again, guys. Let’s recall, ph2 study of ‘3100 finished late '14. Nearing end ’16, ph3 not started, now on FDA hold.”

Its shares dropped by more than 14% premarket on the news.


Suggested Articles

Novartis is forging ahead with the development of spartalizumab in "many, many other indications" despite the setback.

Chi-Med has detailed plans to seek approval from the FDA later this year in part on the strength of data from Chinese phase 3 trial.

Takeda tapped Roche’s Foundation Medicine to develop tissue- and blood-based companion diagnostic tests for its portfolio of lung cancer therapies.