TGX-007 / Trogenix - LARVOL DELTA

Trogenix doses first patient in Phase I/II clinical trial of TGX-007 gene therapy for glioblastoma (GlobeNewswire) - "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."

Trial status • Glioblastoma

ADePT: Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma (clinicaltrials.gov) - P1/2 | N=68 | Recruiting | Sponsor: Trogenix ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Gene Therapies • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

ADePT: Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma (clinicaltrials.gov) - P1/2 | N=68 | Not yet recruiting | Sponsor: Trogenix ltd

New P1/2 trial • Brain Cancer • Gene Therapies • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

An AAV-1 mediated dual-payload gene therapy for high grade glioma (SNO 2025) - "These findings provide the rationale for a first-in-human, phase I/II Bayesian optimal interval study to establish the safety and OBD of TGX-007 and to assess preliminary efficacy of TGX-007 in patients with newly-diagnosed GBM or with first radiological progression of previously treated GBM. TGX-007 will be administered with intra-operative MRI guidance via convection enhanced delivery. Patients will then receive 2 weeks valaciclovir (HSVtk substrate) prior to surgical debulking, then standard-of-care treatment."

Gene therapy • Brain Cancer • Gene Therapies • Glioblastoma • Glioma • High Grade Glioma • Solid Tumor • IL12A • SOX2 • SOX9

ADePT A phase I/II study of an AAV-1 mediated dual-payload gene therapy in patients with high grade glioma (SNO 2025) - "TGX-007 delivers dual genetic payloads, via AAV-1 mediated delivery, which are activated only in tumour cells under control of this SSE...HSV-tk is an enzyme that converts the nucleoside analogue valaciclovir to a cytotoxic molecule, resulting in cell death...Primary endpoints are: Phase I - safety and tolerability, OBD determination; Phase II – OS rate at 12 months (newly-diagnosed population) and 6 months (recurrent population). Secondary and exploratory endpoints include PFS, viral shedding, proof-of-mechanism within tumour tissue."

Clinical • Gene therapy • P1/2 data • Brain Cancer • Gene Therapies • Glioblastoma • Glioma • High Grade Glioma • Solid Tumor • IL12A • SOX2

An AAV-1 mediated dual-payload gene therapy for high grade glioma (WFNOS 2025) - "These findings provide the rationale for a first-in-human, phase I/II Bayesian optimal interval study to establish the safety and OBD of TGX-007 and to assess preliminary efficacy of TGX-007 in patients with newly-diagnosed GBM or with first radiological progression of previously treated GBM. TGX-007 will be administered with intra-operative MRI guidance via convection enhanced delivery. Patients will then receive 2 weeks valaciclovir (HSVtk substrate) prior to surgical debulking, then standard-of-care treatment."

Gene therapy • Brain Cancer • Gene Therapies • Glioblastoma • Glioma • High Grade Glioma • Solid Tumor • IL12A • SOX2 • SOX9

ADePT A phase I/II study of an AAV-1 mediated dual-payload gene therapy in patients with high grade glioma (WFNOS 2025) - "TGX-007 delivers dual genetic payloads, via AAV-1 mediated delivery, which are activated only in tumour cells under control of this SSE...HSV-tk is an enzyme that converts the nucleoside analogue valaciclovir to a cytotoxic molecule, resulting in cell death...Primary endpoints are: Phase I - safety and tolerability, OBD determination; Phase II – OS rate at 12 months (newly-diagnosed population) and 6 months (recurrent population). Secondary and exploratory endpoints include PFS, viral shedding, proof-of-mechanism within tumour tissue."

Clinical • Gene therapy • P1/2 data • Brain Cancer • Gene Therapies • Glioblastoma • Solid Tumor • IL12A • SOX2

Viralgen completes glioblastoma gene-therapy batch production for Trogenix (BioProcess International) - "Viralgen developed a gene-specific titration method and a formulation buffer to serve as a diluent for the drug product's administration....Viralgen cited its successful manufacture of more than 100 GMP batches across various AAV serotypes as providing a strong foundation to navigate new products such as the TGX-007 gene therapy program."

Commercial • Glioblastoma

Viralgen collaborates with Trogenix to advance AAV gene therapy for glioblastoma (PRNewswire) - "Viralgen...has established a strategic collaboration with Trogenix...As part of this partnership, Viralgen successfully scaled-up and completed in under 12 months a good manufacturing practice (GMP) clinical trial material batch of Trogenix's rAAV gene therapy, TGX-007, accelerating the program's progression toward first-in-human (FIH) clinical trials for glioblastoma, one of the most aggressive and treatment-resistant forms of brain cancer....This collaboration underscores Viralgen's commitment to accelerating the development of innovative AAV-based therapies by providing scalable, high-quality manufacturing solutions that help bring treatments to patients faster."

Licensing / partnership • Glioblastoma

Trogenix Unveils Revolutionary Platform to Transform Cancer Treatment Through Precision Viral Immunotherapy (GlobeNewswire) - "Trogenix Ltd today emerged from stealth mode to unveil its groundbreaking therapeutic platform for treating aggressive cancers...The company's lead programme targets glioblastoma (GBM), the most aggressive form of brain cancer, where only 25% of patients survive beyond one year. Preclinical studies have demonstrated curative responses with no toxicity and evidence of persistent anti-tumour immunity, with Phase 1/2 clinical trials planned for 2025."

New P1/2 trial • Glioblastoma