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Transgene (TNG) investor relations material
Transgene Status Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Status Update summary14 Nov, 2025
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.
Statistical power of combined Phase I/II data
Mechanistic synergy with checkpoint inhibitors
Key differentiators of myvac platform
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Frequently asked questions
Transgene SA is a biotechnology company focused on developing innovative immunotherapies for cancer treatment. The company's core expertise lies in the design and development of therapeutic vaccines and oncolytic viruses. Transgene leverages advanced viral vector technology to create targeted treatments that aim to induce immune responses against cancer cells, either by directly attacking them or by enhancing the body's immune system to do so. Key products in its clinical-stage pipeline include TG4050, an individualized therapeutic vaccine developed using the myvac platform, and TG4001, aimed at treating HPV-positive cancers. The company also develops oncolytic viruses like BT-001 and TG6050 under its Invir.IO platform. The company is headquartered in Illkirch-Graffenstaden, France, and its shares are listed on the Euronext Paris.
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