EnGeneIC launches groundbreaking new Australian trial for innovative cancer therapy, with international trial site in Singapore to follow

• First Patient dosed in Phase I/IIa Basket Trial for Solid Tumours at Mater Hospital, North Sydney
• Recruitment to open this month at Frankston Hospital, Victoria
• Further site to follow at Curie Oncology, Singapore
  

/EIN News/ -- SYDNEY, May 12, 2025 (GLOBE NEWSWIRE) -- EnGeneIC Pty Ltd, a Sydney-based biotechnology company and leader in innovative cancer therapies, has announced the successful dosing of the first patient in its open-label, multicentre, Phase I/IIa clinical trial at Mater Hospital, Sydney. The trial (ENG19) is an essential next step in progressing EnGeneIC’s novel platform technology through the clinic and to market. It will assess the safety and efficacy of EGFR-targeted EDV^TM (EnGeneIC Dream Vector) nanocells carrying the super-cytotoxic drug PNU-159682, together with EDVs loaded with an immune-stimulating adjuvant in patients with advanced solid tumours expressing Epidermal Growth Factor Receptor (EGFR).

This groundbreaking 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. Commenting on the significance of this trial, 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 expansion of the trial, EnGeneIC will open recruitment at Frankston Hospital, Victoria, this month under the guidance of Principal Investigator, Professor Vinod Ganju before adding further Australian sites. Additionally, the trial will 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 EnGeneIC’s local representative, as required by the Health Sciences Authority, Singapore.

Dr Himanshu Brahmbhatt, co-CEO of EnGeneIC commented: “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. 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.”

“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.

EnGeneIC's EDV nanocells form the backbone of the company's ongoing commitment to revolutionise cancer therapy by utilising advanced nanotechnology to improve both the precision and efficacy of treatments to stimulate an anti-tumor immune response and to overcome the drug resistance that plagues successful treatment of low survival tumour types.

For more information about the trial or to inquire about participation, please visit www.engeneic.com or contact Stephen Parker whose details are listed below. The trial is registered on the Australia and New Zealand clinical trial site https://www.anzctr.org.au/ACTRN12625000203459.aspx

About EnGeneIC

EnGeneIC is a clinical stage biopharmaceutical company focused on developing novel cancer therapies based on its proprietary platform of EnGeneIC Dream Vector (EDV) nanocells. These nanocells are designed to deliver highly potent drugs directly to cancer cells, providing targeted treatment while minimizing damage to healthy tissue and at the same time stimulate a powerful anti-tumour innate and adaptive immune response. The company’s approach aims to improve the quality of life and extend survival for cancer patients by offering new and more effective therapies for hard-to-treat cancers.

For media inquiries, please contact:

Stephen Parker
Business Operations
sparker@engeneic.com