Safe in pre-clinical animal studies
No toxicities in animals including mice, monkeys, dogs and pigs despite repeat dosing. Many of the brain tumor dogs received between 50 to 100 doses of EGFR-targeted, doxorubicin-packaged EDVs.
Safe in human trials
EnGeneIC has completed a first-in-Man, Phase I safety trial (246 doses of EGFR-targeted, paclitaxel-packaged EDVs administered) in end-stage cancer patients and a Phase I trial (123 doses of EGFR-targeted, doxorubicin-packaged EDVs administered) in recurrent glioblastoma patients. Additionally, a Phase I/IIa trial is currently on-going (so far 197 doses of EGFR-targeted, microRNA-16a-packaged EDVs administered) in end-stage recurrent mesothelioma patients. In all 3 studies, the EDVs were found to be safe for intravenous administration. About 50 percent of the patients experienced a mild rise in body temperature approximately an hour after the dose and some patients also experienced a rigor which subsided within approximately 20 minutes. The temperature returned to normal by about four hours.
Repeat dosing in humans is safe
Many patients received between 15 to 45 repeat doses with no ill effects.
Versatile delivery system
EDV™ can carry many different anti-cancer agents including more potent drugs that can’t otherwise be used, or molecular therapies such as plasmid DNA, siRNA or miRNA.
- No EDV™ modifications are necessary for each therapeutic (unlike requirements for transport via liposomal, nanoparticle and polymer vectors).
Easy to load
The process of payload packaging is easily accomplished.
- Quick and cost-effective.
Delivers substantial drug payloads
Up to ~ 1 million drug molecules can be packaged per EDV™ and ~10,000 siRNA/miRNA molecules per EDV. ~ 50 – 100 copies of plasmid per EDV. Each of these concentrations have been found to be therapeutically effective against human tumors in mouse, canine and human studies.
Easy to store
EDV™ can be dehydrated to a powder (lyophilised), permitting storage for at least 12 months without loss of activity.
- Can be shipped worldwide
- Anti-tumor activity is maintained
EDV™ do not carry DNA from the bacterial source.
- No endogenous genetic material
- Cannot reproduce
Small enough to escape blood stream through the leaky vasculature and into the tumor micro-environment without entering into normal tissues.
- ~ 400nm diameter
Resilient outer biological membrane
- Unlike synthetic particles, the contents of EDV™ do not leak out once packaged in the particle
- This results in minimal to no toxicity from the payload of toxic chemotherapeutic drug or siRNA when carried in EDV™.
Can be targeted to any tumor cell surface receptor
Since the targeting of the EDVs to tumor cell is accomplished via a bispecific antibody attached to the surface of the EDV, such antibodies can readily be synthesized to target any tumor cell surface receptor of choice. Therefore, the EDVs can be targeted to a range of different tumors.