Transgene (TNG) Status Update summary

Clinical data and trial progress

• TG4050, an individualized neoantigen vaccine, showed 100% disease-free survival at 24 months in phase I for operable head and neck cancer, with no relapses in the treatment arm and three in the control arm.

• Immunogenicity was robust, with 73% of patients developing T cell responses to vaccine neoantigens, often polyepitopic and including de novo responses.

• T cell responses were durable, persisting up to one year post-treatment, and exhibited cytotoxic, tissue-resident profiles.

• TG4050 expanded and diversified the tumor-specific T cell repertoire, including both new and pre-existing tumor-infiltrating clones.

• Phase II trial randomization is expected to complete in early 2026, with key efficacy and immunogenicity data anticipated between late 2026 and early 2028.

Mechanism of action and translational insights

• TG4050 induces strong, specific, and lasting T cell responses against patient-specific tumor neoantigens.

• Induced T cells display cytotoxic and tissue-resident characteristics, supporting their anti-tumor potential.

• Both new and pre-existing tumor-infiltrating T cell clones are expanded, confirming the vaccine’s ability to recall and diversify anti-tumor immunity.

• The immunological findings are consistent with the observed clinical efficacy and support the vaccine’s mechanism of action.

Strategic outlook and future plans

• Plans are underway for a new phase I trial in a second solid tumor indication, combining TG4050 with a checkpoint inhibitor.

• Recruitment and immunogenicity data for this new trial are expected within 12 months of initiation.

• The company aims to leverage its myvac platform for broader applications in operable solid tumors at risk of relapse.

• Key milestones include three-year disease-free survival analysis for phase I in 2026 and first phase II immunogenicity data by end of 2026.

• Feedback from clinicians and KOLs has been highly positive, with excitement about the translational and clinical results.