EnGeneIC has announced the dosing of the first patient in its open-label, multicentre, Phase I/IIa clinical trial at Mater Hospital in Sydney.
EnGeneIC stated that the trial (ENG19) is the next step in advancing its novel platform technology through the clinic and to market. The trial will assess the safety and efficacy of EGFR-targeted EDV (EnGeneIC Dream Vector) nanocells carrying the super-cytotoxic drug PNU-159682, in combination with EDVS loaded with an immune-stimulating adjuvant, in patients with advanced solid tumours expressing the Epidermal Growth Factor Receptor (EGFR).
This study targets patients for whom second-line therapy is no longer working or for whom first- and/or second-line treatments are not appropriate. The trial will focus on EGFR-positive cancers that are difficult to treat and have a poor prognosis, including but not limited to non-small cell lung cancer (NSCLC), mesothelioma, kidney and bladder cancer, pancreatic cancer, head and neck cancer, medullary thyroid cancer, and triple-negative breast cancer.
Professor Fran Boyle and Dr Luke Ardolino are investigators for the trial at the Mater Hospital.
Professor Boyle said, “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.”
As part of the trial's expansion, EnGeneIC will open recruitment at Frankston Hospital in Victoria this month, under the guidance of principal investigator Professor Vinod Ganju, before adding further Australian sites.
The trial will also be launched internationally at Curie Oncology in Singapore, where Dr Su Pin Choo will lead the study and EnGeneIC collaborator, Singapore Advanced Medicine (SAM, Dr. S. K. Djeng) will serve as the company's local representative, as required by Singapore's Health Sciences Authority.
Dr Himanshu Brahmbhatt, the co-CEO of EnGeneIC, said, “The EDV nanocell therapy is a globally unique technology that stimulates a complete orchestra of anti-tumour responses, individual to every patient. In early clinical studies, even patients who had exhausted all treatment options have responded. Most anti-cancer therapies are designed to hit only one tumour-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 tumour keeps coming back.”
“In this clinical trial, we aim to identify which cancer indications show a favourable outcome. 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,” he added.