Trogenix doses first patient in Phase I/II clinical trial of TGX-007 gene therapy for glioblastoma

• UK and US trial sites open; first patient dosed with TGX-007, Trogenix’s proprietary dual-payload AAV gene therapy
• TGX-007 leverages Trogenix’s precision synthetic super-enhancer platform that selectively activates therapeutic immune payloads within tumour cells while limiting off-target toxicities
• Start of the ADePT trial supports the Company’s vision for a potentially transformative "one time" treatment across multiple solid cancers
  
  

Edinburgh, UK, 28 May 2026 – Trogenix Ltd (“Trogenix” or the “Company”), a clinical-stage oncology company engineering programmable immunotherapies, today announces that the first patient has been dosed in its Phase I/II clinical trial evaluating TGX-007, a dual-payload adeno-associated virus (AAV)-based gene therapy. It will treat patients with newly diagnosed or recurrent glioblastoma (GBM), one of the most common and aggressive forms of brain cancer.

The trial, named ADePT, is being conducted at two leading clinical sites: NHS Lothian, UK, and Ohio State University Hospital, USA. The seamless trial design will identify the optimal biological dose of TGX-007 and evaluate its safety and efficacy in newly diagnosed and recurrent GBM patients. It will generate clear and early insights into biological activity, tumour selectivity, safety, target engagement, immune activation and overall survival in GBM patients. The initial clinical data will immediately drive the Company’s broader vision, enabling testing of a potentially transformational treatment approach across many different solid tumours.

Ken Macnamara, Chief Executive Officer of Trogenix, commented: “We’re excited to advance the ADePT clinical trial and bring a potentially transformative “one time” treatment to patients with significant unmet need. With precisely controlled therapeutic delivery, a strong safety profile, and support from US and UK regulators, we are positioned to treat newly diagnosed and recurrent glioblastoma patients ahead of standard-of-care. The trial will provide meaningful clinical endpoints for high-grade gliomas and inform development across our broader solid tumour pipeline. We are grateful to the patients, investigators and clinical teams for making this possible and look forward to reporting data from the trial in due course.”

TGX-007 harnesses Trogenix's proprietary Synthetic Super-Enhancer (SSE) technology to exploit the core cancer cell identity. In doing so, the programmable immunotherapy can switch on combination payloads to precisely kill tumour cells and activate the immune response. The dual mechanism of action, delivered via a single vector, creates synergistic effects that act as an in-situ vaccination to provide long lasting protection from a “one time” treatment.

Faye Robertson, Chief Investigator, Consultant Clinical Oncologist and Honorary Clinical Senior Lecturer University of Edinburgh, added: “Despite decades of research, outcomes for patients with glioblastoma remain extremely poor, underscoring the urgent need for innovative therapeutic approaches. The start of the Phase I/II ADePT trial is a critical moment for patients facing this challenging and devastating disease. It is the culmination of more than a decade of research in pursuit of a therapy that delivers dual therapeutic payloads with exceptional precision directly to glioblastoma cells, while sparing surrounding healthy tissue. We are delighted to have treated the first patient in Edinburgh and look forward to progressing ADePT to determine whether this approach translates into meaningful clinical benefit for patients.”

The first patient dosing in the ADePT trial follows the publication in Nature in April 2026 of a breakthrough pre-clinical study led by Professor Steve Pollard, Chief Scientific Officer of Trogenix, demonstrating that a single dose of SSE-based therapy achieved complete tumour eradication in 83% of treated cases in an aggressive brain cancer model that closely mimics human GBM, with no toxicity over 11 months and no tumour recurrence. The ADePT trial will establish the clinical proof-of-concept that will guide the Company’s broader pipeline development across colorectal, liver, and lung cancers.

Further details of the ADePT trial can be found here: NCT07346144

-ENDS-

About Trogenix

Trogenix unites cutting-edge technologies in genomics, oncology, immunotherapy, and gene therapy to create a revolutionary therapeutic approach through its Odysseus® platform. Using proven AAV vectors, our proprietary Synthetic Super-Enhancers (SSEs) and linked payloads are delivered directly to tumour cells without detection. Our SSEs enable unprecedented precision in gene control, effectively revealing cancer to the body's immune system and killing tumour cells. For any cells escaping Trogenix's technology, our 'Trojan horse' can counter recurrence, therefore offering a single treatment for aggressive tumours that delivers long-lasting protection. With our lead asset in GBM now in the clinic, we're ready to transform treatment paradigms across multiple cancer types.

Trogenix launched in 2023 based on co-founder Professor Steve Pollard’s groundbreaking research at the University of Edinburgh – including its UK Centre for Mammalian Synthetic Biology and Institute for Regeneration and Repair – and the Cancer Research UK Scotland Centre. In October 2025, the Company completed a £70m/$95m Series A financing led by IQ Capital with investment from its existing investors and new investors Eli Lilly & Co., Meltwind, LongeVC and Calculus Capital. The funding is enabling the rapid advancement of Trogenix’s robust pipeline of potentially curative cancer therapies across multiple aggressive solid tumours into the clinic.

For more information, visit www.trogenix.com.

About TGX-007

TGX-007 is Trogenix’s lead investigational gene therapy asset, delivered via adeno-associated virus (AAV) vector directly into the tumour by intratumoural injection. It harnesses Trogenix’s proprietary Synthetic Super-Enhancer (SSE) technology, engineered genetic constructs that act as selective transcriptional switches, designed to exploit the unique transcriptional machinery of glioblastoma (GBM) stem cells, to deliver two therapeutic payloads with high precision to tumour cells whilst sparing surrounding healthy tissue. The first payload, herpes simplex virus thymidine kinase (HSV-tk), converts the orally administered pro-drug valaciclovir into an active cytotoxic agent that directly kills proliferating tumour cells. The second payload, interleukin-12 (IL-12), activates the immune system to recognise and attack the tumour, generating durable immunological memory that has the potential to prevent cancer recurrence. By combining direct tumour cell killing with immune activation in a single agent, TGX-007 acts as an in-situ vaccine, with potential to transform GBM treatment from a temporary intervention into lasting protection.

About ADePT

The ADePT (AAV Mediated Dual-Payload Gene Therapy in patients with high grade glioma) trial is a Phase I/II open-label clinical trial of TGX-007 in approximately 65 patients with newly diagnosed and recurrent GBM. Eligible patients will receive a single intratumoral injection of TGX-007 followed by the pro-drug valaciclovir orally for up to 21 days before proceeding to standard-of-care surgery. Patients will be monitored on an ongoing basis for safety and survival.

About Glioblastoma

Glioblastoma is the most common and aggressive primary brain tumour in adults, affecting approximately 200,000 people globally every year. Despite decades of research, standard of care treatments still leave newly diagnosed glioblastoma patients with a median overall survival of approximately 15 months, decreasing to approximately 6 months median survival in recurrent patients¹. There remains a critical unmet need for new treatment approaches capable of delivering durable responses and long-term immunological protection against this devastating disease.

For more information, please contact:
Trogenix Ltd.info@trogenixbio.com

Media and Investor Enquiries:

ICR Healthcare

Amber Fennell, Namrata Taak, Chris Welsh

Tel: +44 (0) 20 3709 5700

trogenix@icrhealthcare.com

¹ Sipos D, Raposa BL, Freihat O, Simon M, Mekis N, Cornacchione P, Kovács Á. Glioblastoma: Clinical Presentation, Multidisciplinary Management, and Long-Term Outcomes. Cancers (Basel). 2025 Jan 5;17(1):146. doi: 10.3390/cancers17010146. PMID: 39796773; PMCID: PMC11719842.