Transgene (TNG) Status Update summary

Clinical trial progress and results

• TG4050, an individualized neoantigen cancer vaccine, achieved 100% relapse-free survival at 30 months in the vaccine arm versus 81% in the control arm, with durable T-cell responses up to two years and no significant adverse events.

• All trial endpoints were met, including safety, feasibility, immune activation, and disease-free survival, with treatment well-tolerated and no unexpected safety signals.

• The phase II randomized study in early-stage head and neck cancer began in May 2024, with final patient randomization expected by end of 2025 and efficacy data anticipated by late 2027 or early 2028.

• Recruitment for the phase II study is complete, and the program is ahead of schedule, aiming to include approximately 80 patients internationally.

• The trial focused on high-risk, HPV-negative, resectable head and neck cancer patients, with all patients in the vaccine arm remaining disease-free.

Technology and platform

• TG4050 is based on the myvac® platform, utilizing viral vector technology and NEC's AI-driven neoantigen selection for individualized immunotherapy.

• The myvac® approach enables fully tailored, patient-specific immunotherapies targeting solid tumors.

Scientific and competitive landscape

• Cancer vaccines are now recognized as effective, especially in the adjuvant setting, where the immune system is less suppressed and clinical efficacy is more demonstrable.

• Combining TG4050 with checkpoint inhibitors like anti-PD-1 is seen as a promising strategy, particularly for patients with low PD-L1 expression or T-cell poor tumors.

• Bispecific antibodies (e.g., Bicara, Merus) are emerging as promising competitors, but the unique viral vector and AI-driven neoantigen selection differentiate TG4050.