Inovio Biomedical Corp. has announced that interim data from a clinical study of an experimental DNA-based prostate cancer vaccine demonstrated that Inovio’s DNA delivery technology significantly enhanced the potency of the gene-based vaccine.
Dr. Christian H. Ottensmeier, MD, PhD, Cancer Research UK Senior Clinical Research Fellow at the University of Southampton, will present interim data at the 3rd International Conference on DNA Vaccines in Malaga, Spain, from this University of Southampton Phase I/II clinical study of a prostate cancer vaccine, a proprietary product owned by a third party, delivered by Inovio’s electroporation technology.
The results demonstrated safety, tolerability and significantly higher antibody responses for patients who received the vaccine with Inovio’s delivery system versus those who were treated without it.
Inovio’s electroporation-mediated DNA delivery system is designed to enhance the potency of DNA-based immunotherapies against cancers and infectious diseases.
Inovio Biomedical has been collaborating with Dr. Ottensmeier since 2005 on this University of Southampton clinical study, titled “A Phase I-II Trial of a DNA Vaccine with a PSMA27/pDOM Fusion Gene Given by Intramuscular Injection in HLA2+ Patients with Prostate Carcinomas with or without Electroporation.”
This study of patients with recurrent prostate cancer, approved by the United Kingdom Medicines and Healthcare Products Regulatory Agency, is assessing safety, tolerability, and cellular (T-cell) and humoral (antibody) immune responses to a plasmid-based cancer vaccine delivered using Inovio’s proprietary DNA delivery technology.
In each of the two arms of this study, i.e. with and without electroporation-enhanced delivery, three patient groups are being treated using escalating dosage levels. A total of 24 patients have been treated out of a total objective of 30 patients.
An analysis of interim data from the first and partially from the second dose treatment groups demonstrated the following points:
• Electroporation appears safe and it is well tolerated.
• The number of patients with significant antibody responses was four of 10 in the patient groups treated without electroporation compared to nine of 10 in the patient groups treated with electroporation.
• The magnitude of the antibody response was significantly higher in patients treated using electroporation. Data on the T-cell response is being compiled.
The investigators continue to enroll and treat patients in the higher-dosage treatment groups.
“These data demonstrate for the first time in a clinical trial that the significant enhancement in potency of a gene-based vaccine delivered by electroporation in animals can also be seen in humans,” said Dr. Christian Ottensmeier, clinical investigator of the study.
“Achieving validation that the compelling pre-clinical data generated by Inovio and partners in large animal models can be achieved in humans is a key milestone for Inovio,” stated Avtar Dhillon, MD, Inovio’s CEO.
“These results suggest that Inovio’s electroporation DNA delivery technology may provide an important alternative to viral and other DNA delivery technologies and could play a profound role in safely augmenting the immune response generated by future prophylactic and therapeutic immunotherapies against cancers and infectious diseases such as HIV and hepatitis C,” added Dr. Dhillon.”