Inovio: VGX-3100 data showed immune correlates, signatures predictive of success
Inovio Pharmaceuticals announced that post-hoc analysis of data generated from its phase 2b trial of VGX-3100 identified immune correlates and biomarker signatures predictive of treatment success. VGX-3100, Inovio's lead product now in a pivotal phase 3 trial, would be the first non-surgical treatment for HPV-associated high grade cervical dysplasia which frequently progresses to cancer. Details of the new biomarker and immunologic data are highlighted in the peer-reviewed journal Clinical Cancer Research in the article, "Clinical and Immunologic Biomarkers for Histologic Regression of High-grade Cervical Dysplasia and Clearance of HPV-16 and HPV-18 after Immunotherapy," by Inovio and its academic collaborators. In this paper, Inovio has identified biomarker signatures which predicted success of VGX-3100 treatment as early as two weeks after the completion of treatment which was a full 22 weeks prior to the formal efficacy assessment. The company believes these biomarkers will aid physicians in guiding patient care during VGX-3100 treatment, and is pursuing the confirmation of these predictions in its phase 3 program. Inovio is also researching pre-treatment biomarkers which could identify patients most likely to respond to treatment with VGX-3100, increasing absolute efficacy of the product. Dr. J. Joseph Kim, President and CEO, said: "Inovio will transform the treatment of HPV-associated disease with the first immunotherapies to treat both pre-cancer and cancer caused by HPV which infects more than 70% of sexually active adults. Today's advancement in discovering a successful treatment biomarker moves us closer to that goal."