Clinical Pipeline

Advancing precision cancer therapies with EDV™ nanocells for pancreatic cancer, EGFR-expressing tumours and recurrent glioblastoma

Clinical Trial

Location

Phase I

Phase II

Trial Design

Pancreatic Cancer

USA

In Progress 75%

Phase I/IIa – EGFR expressing 2L PDAC therapy, randomised, blinded with control arm. NCT07049055

Recurrent Glioblastoma

AUS

In Progress 75%

Phase I/IIa – Evaluate safety and tolerability in EGFR expressing recurrent glioblastoma. ACTRN12625000779471

Low Survival Cancers

AUS

In Progress 75%

Phase I/IIa – EGFR expressing cancers basket clinical trial. ACTRN12625000203459

Cancer Indications

EnGeneIC is advancing its EDV™ (EnGeneIC Dream Vector) nanocell technology in clinical studies for patients with advanced cancers, particularly those who have progressed after standard therapy or for whom standard treatments are not suitable. Current programs include metastatic pancreatic ductal adenocarcinoma (PDAC), EGFR-expressing solid tumours, and recurrent glioblastoma.

Metastatic Pancreatic Cancer (PDAC)

EnGeneIC is conducting a Phase I/IIa randomized, blinded trial in patients with EGFR-expressing PDAC whose disease has progressed following first-line therapy with a 5-fluorouracil-based combination including irinotecan and oxaliplatin. E-EDV-D682/GC will be given in combination with gemcitabine and nab-paclitaxel versus gemcitabine and nab-paclitaxel alone.

Recurrent Glioblastoma

EDV technology is being tested in a Phase I/IIa trial for EGFR-expressing recurrent glioblastoma patients whose disease has returned, or progressed after standard care. The study evaluates safety, efficacy, overall survival, progression-free survival, and tumour response using imaging and RANO 2.0 criteria, which distinguish real tumour growth from transient treatment effects.

EGFR-expressing solid tumours (basket study)

The EDV platform is also being evaluated in a Phase I/IIa trial across multiple EGFR-expressing cancers for patients who have progressed after one or two prior therapies, or for whom standard treatments are unsuitable. Indications include:

  • Lung cancer (NSCLC, mesothelioma)
  • Bladder and kidney cancer
  • Colorectal cancer
  • Triple-negative breast cancer (TNBC)
  • Pancreatic ductal adenocarcinoma (PDAC)
  • Other EGFR-expressing tumours (head and neck cancer, malignant melanoma, neuroendocrine tumours).

The study assesses safety, tolerability, overall survival, and tumour response using radiological and iRECIST criteria, which help differentiate true progression from temporary treatment-related changes.

Looking ahead, EnGeneIC is advancing clinical development, strategic partnerships, and global expansion – with the goal to deliver transformative therapies to patients with the most difficult-to-treat cancers.