Australian biotechnology company EnGeneIC has announced the successful dosing of the first patient in a groundbreaking Phase I/IIa clinical trial of its proprietary EnGeneIC Dream Vector (EDV) nanocell technology for advanced solid tumors. The open-label, multicenter study is evaluating EGFR-targeted EDV nanocells loaded with the super-cytotoxic drug PNU-159682, administered in combination with EDVs containing an immune-stimulating adjuvant.
The trial, designated ENG19, commenced at Mater Hospital in Sydney and represents a critical step in advancing EnGeneIC's novel platform technology through clinical development. The study specifically targets patients with EGFR-positive cancers who have progressed on second-line therapy or for whom standard first- and second-line treatments are not appropriate.
Target Patient Population and Cancer Types
The trial focuses on difficult-to-treat EGFR-positive cancers with poor prognosis, including:
- Non-small cell lung cancer (NSCLC)
- Mesothelioma
- Kidney and bladder cancer
- Pancreatic cancer
- Head and neck cancer
- Medullary thyroid cancer
- Triple-negative breast cancer
Professor Fran Boyle, an investigator for the trial at Mater Hospital alongside Dr. Luke Ardolino, expressed optimism about the study's potential: "We are thrilled to be part of this innovative study, which has the potential to offer new hope to patients suffering from aggressive EGFR-expressing cancers. The treatment combines cutting-edge technology with a promising therapeutic approach, which has the potential to change the way we treat these challenging cancers."
Expanding Trial Sites
As part of its strategic expansion, EnGeneIC plans to open recruitment at Frankston Hospital in Victoria this month under the guidance of Principal Investigator Professor Vinod Ganju. Additional Australian sites are expected to join the trial in the coming months.
The company is also extending the trial internationally, with plans to launch at Curie Oncology in Singapore. Dr. Su Pin Choo will lead the Singapore arm of the study, with EnGeneIC collaborator Singapore Advanced Medicine (SAM, Dr. S.K. Djeng) serving as the company's local representative as required by Singapore's Health Sciences Authority.
Unique Mechanism of Action
The EDV nanocell platform represents a novel approach to cancer treatment. Unlike conventional therapies that typically target a single tumor-specific pathway, EDV nanocells are designed to stimulate a comprehensive anti-tumor immune response tailored to each patient.
Dr. Himanshu Brahmbhatt, co-CEO of EnGeneIC, explained the technology's unique advantages: "The EDV nanocell therapy is a globally unique technology that stimulates a complete orchestra of anti-tumor responses, individual to every patient. In early clinical studies, even patients who had exhausted all treatment options have responded."
He highlighted a key challenge in cancer treatment that EDV technology aims to address: "Most anti-cancer therapies are designed to hit only one tumor-specific target, but the difficulty lies in the fact that as the cancer progresses, it becomes highly heterogeneous, resulting in some cells escaping the therapy. This means that the multi-drug and/or immunotherapy-resistant tumor keeps coming back."
Trial Objectives and Future Directions
The primary objectives of the ENG19 trial include assessing safety and efficacy while identifying which cancer types show the most favorable responses to the EDV nanocell approach.
"In this clinical trial, we aim to identify which cancer indications show a favorable outcome," Dr. Brahmbhatt noted. "This trial will accelerate the development of this potentially life-changing treatment for patients, by EnGeneIC's engagement with a committed group of investigators and clinical sites. It is a huge step for us as we take EDV therapy forward in larger, defining, clinical trials for these unresponsive low survival cancers."
EnGeneIC's EDV nanocells form the backbone of the company's ongoing commitment to revolutionize cancer therapy by utilizing advanced nanotechnology to improve both the precision and efficacy of treatments. The platform is designed to stimulate anti-tumor immune responses while overcoming the drug resistance that often limits successful treatment of aggressive cancers.
The trial is registered on the Australia and New Zealand clinical trial registry (ACTRN12625000203459), and interested patients can find more information on the company's website or by contacting EnGeneIC directly.
