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

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 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 that provides 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 dualtherapeutic 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

Cancer Research Horizons is the innovation engine of Cancer Research UK – the world's largest charitable funder of cancer research. It brings together world-leading minds, bold ideas and the right partners to bridge the gap between academic research and taking drugs to market. It focuses on the tougher, more profound ideas that can lead to true innovation, translating them into effective treatments and diagnostics for cancer patients. To date, it has played an instrumental role in forming over 90 start-ups. It has helped bring 14 cancer drugs to market, born out of Cancer Research UK's pioneering research. Through these drugs, it has enabled in excess of 6 million courses of treatment for cancer patients across the world. With access to Cancer Research UK's network of 4,000 exceptional researchers, and £400m of annual research spend, it is a powerful partner in the fight to conquer cancer. By uniting its commercial partnerships and therapeutic innovation capabilities, Cancer Research Horizons is uniquely placed to support translational funding, entrepreneurial development, data licensing and collaboration, spin-out creation, and offer a full spectrum of drug discovery and clinical capabilities. Every penny it makes goes back into funding the next bold steps, to help bring forward the day when all cancers are conquered.  

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 a long-lasting protection. With our lead asset in GBM entering 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. Incubated by 4BIO Capital, additional seed funding was provided through IQ Capital, Cancer Research Horizons, the US National Brain Tumour Society’s Brain Tumour Investment Fund, AIN Ventures and the University of Edinburgh’s venture investment fund, Old College Capital. In addition, Innovate UK provided an Investor Partnership grant in support of Trogenix’s pre-clinical research into its liver hepatocellular carcinoma and colorectal cancer liver metastases programmes. 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 will enable 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.

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.

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.

Glioblastoma is the most common and aggressive primary brain tumour in adults, affecting approximately 200,000 people globally every year. Despite decades of research, the standard of care treatments still leave patients with a median overall survival of approximately 15 months from diagnosis. With only 25% of patients surviving beyond one year from diagnosis1 there remains a critical unmet need for new treatment approaches capable of delivering durable responses and long-term immunological protection against this devastating disease.

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