FDA Removes Clinical Hold On Inovio Pharma's VGX-3100, Its First Drug To Enter A Pivotal Study

Inovio's study will assess the efficacy of VGX-3100 in regressing cervical high-grade squamous intraepithelial lesions, a direct precursor to cervical cancer, and eliminating the HPV infection that causes these lesions.

The company suffered a setback when the U.S. Food and Drug Administration placed a clinical hold on the phase 3 trial but after satisfying the agency's request for information the clinical hold has since been removed. The announcement helped boost Inovio's stock higher by around 1.35 percent ahead of Thursday's market open.

H.C. Wainwright Maintains At Buy

Raghuram Selvaraju of H.C. Wainwright & Co maintains a Buy rating and $13 price target after Inovio's announcement.

VGX-3100 happens to be the first candidate within the company's extensive pipeline to proceed with a pivotal study, the analyst noted. In fact, it also happens to be the first immunotherapy and non-surgical treatment for HSIL.

"We note that the design of the REVEAL studies is similar to the design of the Phase 2b trial, in which VGX-3100 was given intramuscularly at 0, 4, and 12 weeks," the analyst said. "The primary endpoint in the Phase 2b trial was regression to CIN 1 or normal pathology at 36 weeks."

The analyst added:

"Importantly, overall HPV-specific T cell levels in VGX-3100 recipients in the Phase 2b trial were greater than those in placebo recipients at all observation periods. CD8+ T cells were generated in the blood and had substantial infiltration in the cervical tissue of VGX-3100 recipients. This clearly demonstrates the correlation of antigen-specific CD8+ T cells to clinical efficacy, in our view."

At time of publication, shares of Inovio were up 4.8 percent at $7.74.