Reidy Center's Heller Leads Bioelectric Grant to Study Novel Gene Therapy Approach to Melanoma

Richard Heller (left) receiving an award from ODU Chief Operating Officer David Harnage

Researchers at Old Dominion University, Eastern Virginia Medical School and biomedical research firm OncoSec Medical, Inc., have received a $585,000 grant from the Virginia Biosciences Health Research Corp. to study a novel gene therapy approach in the treatment of malignant melanoma.

The deadliest form of skin cancer, occurring with increasing frequency, malignant melanoma will be diagnosed in an estimated 75,000 new patients in 2014, with 20 percent of diagnoses resulting in metastatic spread.

Recent advances in treatment have improved overall survival of malignant melanoma. However, the immunotherapy used in treatment - ipilimubab - has proven to be toxic and financially restrictive for patients, healthcare providers and insurers.

The ODU-EVMS-OncoSec study includes an approach for controlled delivery of plasmid DNA that can stimulate an anti-tumor response with minimal toxicity. The approach utilizes pulse electric fields to deliver the immunotherapy directly to the melanoma cells.

This localized delivery elicits responses both in treated and untreated lesions, indicating that anti-tumor immune responses are present. And since it is localized, toxicities that typically occur with systemic doses of the therapy are minimized.

The study, "Biomarker-Driven Optimization of IL-12 Gene Electrotransfer for the Treatment of Melanoma," brings together expertise from ODU's Frank Reidy Research Center for Bioelectrics, the EVMS Leroy T. Canoles Jr. Cancer Research Center and OncoSec Medical.

Each partner contributes expertise that is critical to the success of the proposed study. The Reidy Center has the experience and facilities to conduct preclinical studies and determine the best approach for the combination studies. The EVMS' Canoles center has world-class capabilities in proteomics and expertise in biomarker development. OncoSec has the clinical and regulatory teams in place to move the project forward and has experience with the technology, having conducted two clinical trials using this therapeutic approach.

Reidy Center Director Richard Heller, professor and Eminent Scholar of the School of Medical Diagnostics and Translational Sciences in Old Dominion University's College of Health Sciences, is principal investigator on the grant. Heller, a pioneer in electrogenetherapy, has developed the technology from the laboratory benchtop through clinical studies. He is an inventor of the IL-12 protocol being used in this project.

"This is an excellent opportunity to move this technology forward in a manner that will be beneficial to a larger number of patients," Heller said. "I am looking forward to working with Dr. Semmes and his team at EVMS and Dr. Pierce and his team at OncoSec on this exciting and ground breaking project."

EVMS' team, led by O. John Semmes, Ph.D., the Anthem Distinguished Professor for Cancer Research and director of the Leroy T. Canoles Jr. Cancer Research Center, is applying its expertise in proteomics to identify a biomarker - a protein signature of a specific biological process - that will indicate the presence and extent of the body's response to the IL-12 therapy. This insight will guide efforts to determine the dosing strategy that elicits the most effective anti-tumor response with the fewest undesirable side effects.

"We want to identify a panel of proteins that will inform us a strong IL-12 response has been generated," Semmes says. "Once we have that, we can begin to optimize the drug delivery to achieve the best clinical response in humans."

Dr. Robert H. Pierce, chief scientific officer of OncoSec, said medical researchers currently have to wait to observe clinical tumor regressions to know if a given treatment cycle has worked.

"If we had in our hands a near real-time blood-based biomarker, which indicated the success of a treatment and its relative strength, then we could quickly optimize and accelerate our development. Hopefully, we can find a biomarker approach that is generalizable - beyond IL-12 - to all of our future intratumoral gene-electro transfer targets."

ODU's Frank Reidy Research Center for Bioelectrics has as its mission increasing scientific knowledge and understanding of the interaction of electromagnetic fields and ionized gases with biological cells, and applying this knowledge to the development of medical diagnostics, therapeutics and environmental decontamination.

The EVMS Leroy T. Canoles Jr. Cancer Research Center is dedicated to translational research that leads to improved care for the types of cancer most prevalent in our community. Clinicians and scientists collaborate to connect the laboratory and the physician's office. The center's scientists seek to expand research into new diagnostic and therapeutic tools as a means to improve physicians' ability to identify the best course of treatment for each patient.

OncoSec Medical is a biopharmaceutical company developing its ImmunoPulse intratumoral cancer immunotherapy. As the company continues to evaluate ImmunoPulse in its current indications, it is also focused on identifying and developing new immune-targeting agents, investigating additional tumor indications, and evaluating combination-based immunotherapy approaches.