DNA Vaccine Delivered Using Electroporation Shows Potential to Treat Cervical Cancer and Precursor Dysplasias; Vaccine to Start Phase II in Early 2011
BLUE BELL, Pa., Sep 13, 2010 (BUSINESS WIRE) — Inovio Pharmaceuticals, Inc. /quotes/comstock/14*!ino/quotes/nls/ino (INO 1.11, 0.00, 0.00%) , a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has achieved best-in-class immune responses in its Phase I dose escalation study of VGX-3100, its DNA vaccine to treat pre-cancerous cervical dysplasias and cervical cancers caused by human papillomavirus (HPV) types 16 and 18. This vaccine targets HPV E6 and E7 proteins and is delivered via in vivo electroporation. All dose groups developed significant antibody and T-cell immune responses; however, more notably, in the third and final dose group, five of six (83%) patients developed unprecedented T-cell responses not achieved by any other non-replicating vaccine platform in humans. Inovio is planning to start a Phase II clinical study in the first quarter of 2011.
Preliminary data from the trial indicate:
— Antigen-specific, dose-related T-cell responses across the three dose groups, averaging 1362 SFU per million cells in the high dose group responders
— Strong antigen-specific antibody responses in all three dose groups
— VGX-3100 delivered using Inovio’s proprietary CELLECTRA(R) intramuscular electroporation delivery device was generally safe and well tolerated at all dose levels
— There were no vaccine-related serious adverse events. Reported adverse events and injection site reactions were mild to moderate and required no treatment.
Stanley A. Plotkin, M.D., Emeritus Professor, Wistar Institute and University of Pennsylvania, stated: “Considering that cellular (T-cell) immune responses are known to correlate with suppression of oncogenic transformation (i.e. cell changes that lead to cancer) by HPVs, this study shows the potential for a new therapeutic vaccine to treat cervical dysplasias and cancers caused by those viruses. These are diseases with great unmet medical needs affecting millions of women around the world. The results include some of the best-ever T-cell immune responses induced by a non-replicating vaccine in humans. Therefore, Inovio’s DNA vaccine platform could have significant implications and promise for the advancement of DNA vaccines against cancers and other infectious diseases globally.” Dr. Plotkin, a member of Inovio’s scientific advisory board, is a vaccine pioneer who developed the rubella and rabies vaccines still being used today.
Read Full Article…