FDA places clinical hold on Inovio's proposed Phase III programme for VGX-3100

Inovio Pharmaceuticals on Monday revealed that the FDA placed a clinical hold on its proposed Phase III programme for the investigational therapy VGX-3100. The drugmaker said that start of the late-stage programme will likely be delayed until the first half of next year, pending resolutions of the agency's requests, which focus on the Cellectra 5PSP immunotherapy delivery device. Shares in Inovio fell nearly as much as 15 percent on the news.

The company stated that the initial FDA communication included requests for additional data supporting the shelf life of the newly designed and manufactured disposable parts of the Cellectra 5PSP device. Inovio said it is working with the FDA to address the concerns and anticipates that the requested data will be available before the end of this year.

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VGX-3100 is currently under the development for cervical dysplasia, while analysts have estimated that the therapy, if approved, could amass peak revenue of $500 million. Meanwhile, AstraZeneca's MedImmune unit licensed rights to Inovio's experimental immunotherapy INO-3112, which combines VGX-3100 with a DNA-based immune activator encoded for IL-12, last year in a deal potentially worth more than $700 million.

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