Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.EnGeneIC has announced plans to move forward with a Phase 2a clinical trial in the U.S. using its formulation of EGFR-targeted, EDV nanocells packaged with doxorubicin for the treatment of recurrent glioblastoma (GBM), a common and aggressive type of brain tumor.
Subscribe to our email newsletter
In June 2014, EnGeneIC completed a Phase 1 trial in recurrent glioma in Australia and now plans to submit an IND and commence the U.S. clinical program in early 2015.
EnGeneIC’s bacterially-derived EDV nanocells are a powerful nanoparticle drug delivery system designed to directly target and effectively kill tumor cells with minimal toxicity, while at the same time stimulate the immune system’s natural anti-tumor response.
Intravenously injected EDV nanocells exit the leaky vascular system only within tumors and attach to cancer cells via a specially designed, targeted bi-specific antibody.
Once attached, the nanocell is able to enter the tumor cell and deliver a drug payload of up to one million drug molecules per nanocell. In parallel, the bacterial cell wall of the nanocells stimulates key components of the immune system, which are then activated to seek out and destroy cancer cells.
Himanshu Brahmbhatt, Ph.D., joint-CEO of EnGeneIC, continued, "The residual nanocells that do not get into the tumor are picked up by cells of the immune system, and this process reactivates these immune cells that then target the tumor as well. No other technology has been able to combine elements of highly targeted, cytotoxic chemotherapy and cancer immunotherapy into a single therapeutic. Therefore, the EDV™ nanocell is a first-in class cyto-immuno-therapeutic for cancer treatment."
EnGeneIC has conducted extensive pre-clinical, monkey toxicology and early clinical research of its EDV nancoell technology with no serious toxicities observed despite repeat dosing.
In pre-clinical canine brain cancer studies, drug-loaded EDV nanocells demonstrated significant tumor stabilization and regression, including multiple cases of near-complete elimination of a canine brain mass after five to 15 doses of EDV™ nanocells.
In its successful first-in-man Phase 1 clinical study of EGFR-targeted paclitaxel-packaged EDV nanocells, EnGeneIC observed a significant improvement in quality of life, alongside minimal toxicity, in the 22 end-stage, multi-drug resistant cancer patients who participated in the study.
These encouraging results were echoed in a completed Phase 1 trial in 14 recurrent GBM patients treated with EDV nanocells packaged with doxorubicin. Data confirmed the safety profile of EnGeneIC’s nanocell technology.