Transgene presented positive preclinical data for its TG-MVA vaccine candidate at the World Congress on Infectious Diseases (WCID) 2026, demonstrating robust protection against mpox comparable to approved reference vaccines. The data, presented in an oral session, highlights the candidate's potential to address global supply gaps for mpox and smallpox vaccines through a scalable cell-line manufacturing process. This development is significant for biosecurity and pandemic preparedness, particularly given the limited number of current manufacturers.

The TG-MVA candidate utilizes a non-replicating MVA backbone and an innovative cell-line-based manufacturing process. This method aims to overcome industrial limitations associated with Chicken Embryo Fibroblast (CEF) manufacturing, enabling scalable and reproducible production. By leveraging innovations from its myvac platform, Transgene intends to position itself as an additional supplier for mpox and smallpox vaccines in the medium term.

Preclinical evaluations in mice and non-human primate (NHP) models showed that TG-MVA provides strong protection against severe mpox morbidity and mortality. Survival rates were identical to the reference vaccine, with 100% in mouse models and 87% in primate models. The candidate also induced broad humoral and cellular immune responses, including T-cell immunity, with neutralizing antibody levels comparable to the approved reference MVA vaccine.

Alessandro Riva, MD, Chairman and CEO of Transgene, emphasized the strategic opportunity to leverage existing investments in the MVA cell-line platform. He stated that the promising results support the rapid advancement of TG-MVA toward clinical development, with plans to implement next steps in alignment with Health Authorities. The company maintains its financial visibility until early 2028 while pursuing this initiative alongside its core therapeutic vaccine platform.

The oral presentation, titled "Robust Protection Against Monkeypox Virus Mediated by a Novel Cell-Line–Derived MVA Vaccine (TG-MVA CL)," was delivered by Nathalie Silvestre, Head of the Vectorology Laboratory at Transgene. The company remains focused on its individualized therapeutic vaccine platform myvac while expanding into preventive vaccines for Orthopoxvirus infections.

Transgene has initiated a randomized Phase 1 trial evaluating TG4070, an individualized neoantigen therapeutic vaccine, in combination with nivolumab for the adjuvant treatment of resected non-small cell lung cancer (NSCLC). This strategic expansion of the myvac® platform aims to address high relapse risks in patients who do not achieve a major pathological response after neoadjuvant therapy. Patient screening for the trial is scheduled to start in the coming weeks.

TG4070 is the second candidate derived from the myvac® platform, following TG4050, which is currently in Phase 2 for head and neck squamous cell carcinoma. The new candidate integrates Transgene’s proprietary AI-driven bioinformatics tool, SNIPER (Specific Neoantigen Identification and Prediction of Elicited Response), for high-precision neoantigen selection. Additionally, the vaccine is produced using a scalable cell-line based manufacturing process designed to improve lead times and reproducibility compared to conventional methods.

The trial will assess the safety and tolerability of TG4070 in combination with nivolumab. Approximately 65% of early-stage NSCLC patients do not achieve a major pathological response with current perioperative immunotherapy regimens, leaving them at significant risk of relapse. The individualized vaccine approach is designed to induce specific and durable anti-tumor immune responses in this high-risk population.

Key Features of TG4070

• AI-Driven Selection: Utilizes SNIPER to identify and prioritize immunogenic neoantigens.
• Scalable Manufacturing: Employs a cell-line based process for faster vaccine supply.
• Platform Consistency: Leverages the clinically validated Modified Vaccinia Ankara (MVA) viral vector.

Transgene plans to implement cell-line based manufacturing for potential future trials of TG4050 as well. The company will host a conference call on June 29, 2026, at 3:00 p.m. CET to discuss the platform expansion and the medical need for early-stage NSCLC patients.