On July 23, 2015 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported that it is collaborating with the European Organization for Research and Treatment of Cancer (EORTC) to evaluate Inovio’s immunotherapy, INO-3112, in combination with traditional chemo-radiotherapy for the treatment of patients with locally advanced stage cervical cancer. The trial, primarily funded by the EORTC, is expected to begin by the end of the year (Press release, Inovio, JUL 23, 2015, View Source [SID:1234506613]).

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Partnership with the EORTC will offer Inovio clinical trial efficiency and speed in recruiting patients in Europe and in obtaining and analyzing results. The EORTC encompasses all aspects of cancer research, from translational research and new drug development to large phase III clinical trials and meta-analyses. EORTC is the only organization which carries out clinical studies throughout Europe for all types of cancer. Collaboration with the EORTC also leverages their connections to a network of more than 2,500 pre-clinical scientists and oncologists in more than 300 hospitals in over 30 countries.

Dr. J. Joseph Kim, President and CEO, said, "Inovio is focused on taking immunotherapy to the next level. We are the only immunotherapy company that is generating, in vivo, T cells in high quantity that are fully functional and which have demonstrated killing capability correlated with relevant clinical outcomes. We are very pleased that Inovio’s approach attracted the attention of a premier cancer organization like the EORTC to sponsor this important study in women with cervical cancer."

INO-3112 consists of Inovio’s HPV 16 and 18 immunotherapy (VGX-3100) and its IL-12-based immune activator (INO-9012). In this prospective, randomized, three arm phase II study, INO-3112 will be administered during standard chemo-radiotherapy (CRT) or during and after standard CRT as an adjuvant in patients with locally advanced cervical cancer. The primary endpoint is to demonstrate sufficient activity in the experimental combination arms to warrant a further pivotal phase III trial based on progression free survival (PFS) at 18 months. Efficacy will be assessed within each experimental arm while the standard arm will serve as a reference arm to check the reliability of the results. PFS at 18 months will be determined via RECIST criteria as assessed by the local investigator. The co-primary investigators are Georges Coukos, M.D. and Fernanda G. Herrera, M.D., both of whom are with the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland.

Secondary endpoints include overall survival, clinical response, immunogenicity, tolerability and safety.

This international study will enroll patients in several European countries and will complement and build on an Inovio-sponsored study already underway at several centers in the United States (Phase I/IIA, Open-Label, Safety, Tolerability, and Immunogenicity Study of INO-3112 Delivered by Electroporation in Women with Cervical Cancer after Chemoradiation for Newly Diagnosed Disease or Therapy for Recurrent and/or Persistent Disease).

The efficacy and immunogenicity of VGX-3100, the basis of INO-3112, in patients with the precursor to cervical cancer (high grade cervical dysplasia) has already been demonstrated in a large, prospective, randomized, double blind, placebo-controlled phase II study, HPV-003. Treatment with VGX-3100 resulted in histopathological regression of high grade cervical dysplasia to low grade or no disease, meeting the study’s primary endpoint. In addition, the trial demonstrated clearance of the HPV virus in conjunction with regression of cervical lesions, meeting the secondary endpoint. Robust T-cell activity was observed in subjects who received VGX-3100 compared to those who received placebo.