EnGeneIC plans for Phase 2a trial of EGFR-targeted doxorubicin-packaged EDV nanocells for GBM

EnGeneIC, Ltd., an emerging biopharmaceutical company focused on revolutionizing the treatment of cancer through the targeted delivery of therapeutic agents directly to cancer cells, today 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. 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.

Jennifer MacDiarmid, Ph.D., joint-CEO of EnGeneIC, commented:

The EDV™ nanocell technology is unprecedented in that it combines highly targeted and highly potent drug delivery directly to the tumor with the ability to stimulate an immunogenic response to further eradicate the cancer cells. Due to the bacterial nature of the EDV™ nanocells, they are remarkably stable and do not ‘leak’ their payload until they are internalized by cancer cells. In doing so, EDV™ nanocells enable the use of highly cytotoxic chemotherapeutic agents that are normally limited due to unacceptable toxicity to normal tissues, thus offering the potential to maximize efficacy against drug-resistant tumors.

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.

Despite the advances made in oncology treatments, GBM remains a fatal disease, with very few cases resulting in long term survival. In addition to GBM tumor cells being multi-drug resistant, conventional therapies have a difficult time crossing the blood-brain barrier, and even if this protective barrier is bypassed, the brain is highly sensitive to the broad attack these therapies unleash on not just the tumor cells, but also healthy brain cells. EnGeneIC’s EDV™ nanocell technology platform is designed to address these issues, with early human clinical studies showing minimal to no toxicity.

Dr. Brahmbhatt concluded, “Pre-clinical and early human results strongly suggest that EDV™ nanocells could be a potential breakthrough in the treatment of brain cancers and in improving overall survival in these patients – something that has not been done in decades. Based on our current experiences, we also believe our technology platform could maximize the efficacy against difficult-to-treat and drug resistant tumors. We are currently in the initial or planning stages for studies evaluating our drug-loaded EDV™ nanocells in mesothelioma, non-small cell lung cancer and melanoma.”