Transgene (TNG) Status update summary

Program updates and clinical progress

• TG4050, targeting head and neck cancer, completed Phase 1 with 100% 2-year DFS and is in Phase 2, with efficacy data expected by Q1 2028 and first immunogenicity data in H2 2026.

• TG4070, for non-small cell lung cancer, is entering a randomized Phase 1 trial in combination with nivolumab, focusing on high-risk post-surgery patients, with patient screening beginning soon.

• Both TG4050 and TG4070 leverage individualized neoantigen selection, with TG4050 using NEC’s tool and TG4070 using the in-house SNIPER platform.

• The myvacⓇ platform integrates AI, bioengineering, and digital transformation for precision oncology, supporting expansion into additional tumor types.

• The platform is funded until early 2028, supporting ongoing and future clinical development.

Technology and manufacturing advancements

• Transition from chicken embryo fibroblast to scalable, automatable cell line-based manufacturing improves efficiency, scalability, and reduces turnaround time.

• Two GMP manufacturing facilities, including a CDMO, provide flexibility and capacity for individualized vaccine production.

• SNIPER and VacDesignR® are proprietary AI tools for neoantigen identification and vector design, streamlining vaccine development.

• Cell line-based MVA platform is being leveraged for next-generation Monkeypox and Smallpox vaccines, with preclinical data showing efficacy and safety comparable to approved vaccines.

• Plans are in place to use cell-line manufacturing for future TG4050 trials.

Clinical trial design and differentiation

• TG4070 Phase 1 will randomize 30 patients post-surgery to receive nivolumab alone or with TG4070, focusing on those without complete pathological response.

• The perioperative approach in TG4070 integrates neoadjuvant and adjuvant components, differentiating it from other vaccine trials.

• The myvac platform is differentiated by its viral vector approach compared to mRNA, DNA, or peptide-based competitors.

• No specific biomarkers have been identified for TG4070; patient selection is based on pathological response.

• The SNIPER platform has been benchmarked against industry standards and ranks among top performers.