May 28, 2026 —
Trogenix announced that the first patient has been dosed in the ADePT Phase 1/2 clinical trial evaluating TGX-007, the company’s proprietary dual-payload AAV-based gene therapy for patients with newly diagnosed or recurrent glioblastoma, one of the most aggressive forms of brain cancer.
The trial is now open at two clinical sites: NHS Lothian in the UK and Ohio State University Hospital in the US. The study is designed to identify the optimal biological dose of TGX-007 and evaluate its safety and efficacy in glioblastoma patients. It will also assess early biological activity, tumour selectivity, target engagement, immune activation, and overall survival.
TGX-007 uses Trogenix’s proprietary Synthetic Super-Enhancer platform, which is designed to selectively activate therapeutic payloads within tumour cells while limiting off-target toxicities in healthy tissue. The therapy delivers two complementary immune payloads through a single AAV vector, aiming to directly kill tumour cells and stimulate an anti-tumour immune response.
This dual mechanism is intended to act as an in situ vaccination, potentially generating longer-lasting immune protection after a one-time treatment. By using tumour-selective transcriptional control, Trogenix aims to overcome one of the major challenges in solid tumour gene therapy: achieving potent local activity while sparing surrounding healthy tissue.
The start of the ADePT trial follows the publication of preclinical data in Nature in April 2026. In an aggressive brain cancer model designed to closely mimic human glioblastoma, a single dose of SSE-based therapy achieved complete tumour eradication in 83% of treated cases, with no reported toxicity over 11 months and no tumour recurrence.
If the clinical trial demonstrates safety and early activity, TGX-007 could provide proof-of-concept for Trogenix’s broader platform beyond glioblastoma. The company plans to use insights from ADePT to guide future development across additional solid tumours, including colorectal, liver, and lung cancers.
The first patient dosing marks an important milestone for programmable AAV immunotherapy in oncology. For glioblastoma, where outcomes remain poor despite decades of research, TGX-007 represents a novel attempt to combine tumour-selective gene expression, immune activation, and one-time AAV delivery into a single therapeutic strategy.
