Transgene (TNG) Study Update summary

Study design and objectives

• Randomized phase II trial compared TG4001 plus avelumab versus avelumab alone in recurrent or metastatic HPV-16-positive cervical and anogenital cancers.

• Primary objective was improvement in progression-free survival; secondary objectives included overall response rate, duration of response, and survival.

• 100 patients enrolled; open-label, multi-center, randomized design; 90 without liver metastasis analyzed for primary results.

• Predefined subgroup analyses targeted cervical, anal, and genital cancer subgroups.

Key results and findings

• The trial did not meet its primary endpoint of improved progression-free survival in the overall population.

• A preplanned subgroup analysis showed a positive efficacy trend for TG4001 in cervical cancer patients, representing 54% of the study population; further analysis is ongoing.

• TG4001 was well tolerated, with adverse events consistent with previous studies.

Next steps and future plans

• Full dataset analysis, including correlative science data, will be presented at an international conference in the first half of 2025.

• Focus remains on determining the optimal development path for TG4001, especially in cervical cancer.

• Additional data on TG4050 in head and neck cancer will be presented at the Society for Immunotherapy of Cancer conference in November 2024.

• Cash runway is secured until Q4 2025.