IntellipulseTM Platform Technology for Effective Delivery of Therapeutic Agents

Ef Therapeutics Corp., Tampa FL

Investigators

Abstract

The long-term goal of EF Therapeutics is the development and commercialization of next generation technologies that can be used to administer therapeutics for cancer therapies. The specific goal of this project is the translation and eventual commercialization of a next-generation platform technology that can be used for effective administration of pulse electric field (PEF) based therapies. PEF based therapeutics have been utilized as an ablative technique (irreversible electroporation; IRE) as well as for drug (electrochemotherapy; ECT) and gene (gene electrotransfer; GET) delivery. The new platform developed by EF Therapeutics and their collaborators has the potential to enhance multiple PEF technologies and is designed to overcome several shortcomings of the current instrumentation. This specific project is focused on validating and translating the use of GET with the novel platform to enhance non-viral gene delivery for immunotherapy of solid tumors. While there have been significant achievements in utilizing PEF technologies for cancer therapy, the technology has not had any major advances in the past couple of decades and still falls short in achieving general acceptance. A major reason for the successful advances in immunotherapy of cancer is has been the utilization of immune checkpoint inhibitors (ICIs). While encouraging, the therapy is not without shortcomings. ICI therapies are most effective when combined with surgery, chemotherapy, and/or radiotherapy. The concept to be evaluated in this proposal is to deliver two plasmids, one encoding IL-12 and the other encoding the extracellular domain of PD1 directly to a tumor. By performing intratumor delivery, stimulation would be directed against the specific antigens within the tumor microenvironment and would not only result in an effective local response but would also stimulate a systemic response resulting in an abscopal effect. By utilizing a gene-based approach will potentially reduce toxicity and number of treatments needed. This will enable the approach to reach more people, particularly those that do not have access to advanced therapies. The therapy will first be further validated in a mouse model and in veterinary clinical trials of naturally melanoma tumors in companion dogs. The proposed research is described in these Specific Aims: Specific Aim 1. Optimize and validate the IntellipulseTM system for delivery of plasmid DNA encoding immune modulating agents. Specific Aim 2. Evaluate the IntellipulseTM system to deliver a safe and effective therapy for melanoma tumors in companion dogs.