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# FDA Removes Hold on Inovio Immunotherapy
- URL: https://www.fdaweb.com/fda-removes-hold-on-inovio-immunotherapy/
- Published: 2017-06-08T12:00:00.000Z
- Updated: 2026-09-14T22:28:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138895

FDA has removed a clinical hold to allow Inovio Pharmaceuticals to begin a Phase 3 study to evaluate the efficacy of its DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus (HPV). Inovio says the study will evaluate VGX-3100 in regressing cervical HSIL (high-grade squamous intraepithelial lesions), a direct precursor to cervical cancer, and eliminating the HPV infection that causes these lesions. The pivotal data from this trial is intended to support the potential licensure of VGX-3100 as the first immunotherapy for the disease, it adds. The company says it recently “satisfied” the agency’s request for information relating to its Cellectra 5PSP delivery device.

  
VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, targeting the infection and destroying pre-cancerous cells, according to Inovio. “While surgery is effective at removing dysplastic lesions, it does not treat the underlying HPV infection and carries increased risk of cervical incompetence and pre-term birth, which can result in fetal morbidity and mortality,” it says.