Transgene (TNG) Status Update summary

Clinical trial progress and results

• TG4050 achieved 100% relapse-free or disease-free survival at 30 months in the vaccine arm, compared to 81% in the control arm, for early-stage, operable head and neck squamous cell carcinoma, with three relapses in the observational arm.

• Durable, neoantigen-specific CD8+ T-cell responses were observed up to two years post-vaccination, with strong safety, feasibility, and no unexpected safety signals.

• All trial endpoints were met, including immune activation, safety, feasibility, and disease-free survival.

• The randomized phase II study began in May 2024, with final patient randomization expected by end of 2025 and efficacy data anticipated by late 2027 or early 2028; the combined Phase I/II study will include approximately 80 patients internationally.

• The vaccine is being evaluated for broader applicability across other solid tumors, with a second clinical program set to start this year.

Scientific and competitive landscape

• Recent ASCO data and trials (KEYNOTE-689, Nivopost) support immunotherapy as a new standard in early head and neck cancer, with TG4050 potentially offering additional relapse risk reduction.

• TG4050’s viral vector platform, using AI-selected neoantigens, is highlighted as a differentiator, showing efficacy even in patients with low PD-L1 expression or poor immune infiltration.

• Combination strategies with checkpoint inhibitors are under consideration, especially for patients not cured by current standards.

• Competitor bispecific antibodies (e.g., Bicara, Merus) are promising, but TG4050 is positioned as complementary, potentially boosting adaptive immune responses when combined.

Patient selection and future directions

• Patient selection focuses on those with high risk of recurrence, particularly HPV-negative, resectable head and neck cancer.

• The vaccine may benefit patients with low T-cell infiltration and low PD-L1, traditionally less responsive to immunotherapy.

• Plans are underway for pivotal phase III trials and expansion into new tumor indications, with trial designs to be aligned with recent immunotherapy studies.

• Next major data update is scheduled for ASCO 2026, with ongoing annual updates.