Inovio Pharmaceuticals has appointed Mark Stephen Gelder, M.D., as vice president, clinical development. Gelder will be responsible for planning and executing Inovio's clinical development strategy for its immunotherapies against human papillomavirus (HPV)-caused cervical cancer and dysplasia. He will report to Dr. Mark Bagarazzi, Inovio's chief medical officer.
Gelder brings well over a decade of experience in the pharmaceutical industry. Prior to joining Inovio, Gelder was chief medical officer at Heron Therapeutics, an oncology-focused biotechnology company. Gelder's previous experience includes leading therapeutic oncology programs at Pfizer, Wyeth and Bayer, where he was involved in the approval and launch of several cancer therapeutics. He has led international trials, developed global product launch plans and directed the development and execution of phase I to phase IV studies.
In 2014, Inovio reported top-line data from a large, controlled phase II study showing that VGX-3100 was able to eliminate HPV infection and cause complete regression of high grade cervical dysplasia (CIN 2/3). Inovio is taking the steps to publish a paper with the full data set in a peer-reviewed medical journal this year. Based on the results of the phase II, Inovio plans to initiate a phase III study in early 2016.
Inovio has also expanded clinical development of its DNA-based immune therapy products to treat different HPV types and the many diseases they cause by conducting clinical trials for HPV-associated cervical cancer, aero-digestive cancers and head and neck cancer, the fastest growing cancer in men. Interim safety and immunogenicity data from these studies are expected in 2015.
With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include Roche, MedImmune, University of Pennsylvania, DARPA, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program and University of Manitoba.