Announcement • Sep 03

Transgene And NEC Corporation Report 100% Three-Year Disease-Free Survival With TG4050 And Publish Phase 1 Results In Nature Communications

Transgene and NEC Corporation reported sustained 100% three-year disease-free survival (DFS) in patients treated with TG4050 in the Phase 1 part of a randomized Phase 1/2 trial evaluating TG4050, the first individualized neoantigen therapeutic vaccine (INTV) based on the myvac platform, in patients with resected, locally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). The companies also announced the publication of the Phase 1 comprehensive clinical and translational data from the study, for the first time in the peer-reviewed journal Nature Communications. Three-year follow-up data from the Phase 1 trial continue to demonstrate durable clinical outcomes in the adjuvant setting, with all 16 TG4050-treated patients remaining disease-free while three of 16 patients in the control arm experienced relapse after a median follow-up of 41 months. TG4050, encoding up to 30 patient-specific neoantigens, also continues to demonstrate a favorable safety profile with no unexpected safety findings. The peer-reviewed publication builds on the Phase 1 results first shared with the scientific community through a prepublication on medRxiv and presents comprehensive clinical and translational findings based on the study’s primary data cut-off, including detailed analyses of vaccine-induced immune responses. Together, the clinical and translational findings provide further evidence supporting TG4050 as a potential individualized immunotherapy for patients with head and neck cancer at high risk of relapse following surgery and (chemo)-radiotherapy. The Phase 1 clinical and translational data published in Nature Communications demonstrate robust and persistent neoantigen-specific CD8+ T-cell responses consistent with the proposed vaccine’s mechanism of action. Vaccine-induced responses were detected in 73.3% of patients treated with TG4050, with a median of three responding neoantigens per responder. These responses were maintained throughout treatment and persisted for more than one year after the last vaccination, providing evidence of durable anti-tumor immunity. Robust and persistent CD8+ T-cell responses against patient-specific tumor neoantigens were observed following TG4050 vaccination, supporting the vaccine’s ability to generate a targeted anti-tumor immune response. TG4050 continues to be evaluated in the ongoing randomized Phase 1/2 clinical trial (NCT04183166) in patients with resected HNSCC. Key upcoming milestones include first immunological data and two-year efficacy data (DFS) from the Phase 2 study respectively in H2 2026 and First Quarter 2028. TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence (AI) and machine learning (ML) expertise. This virus-based individualized neoantigen therapeutic vaccine (INTV) encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences. TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient. TG4050 is being evaluated in a Phase 1/2 clinical trial for patients with HPV-negative head and neck cancers (NCT04183166). An individualized treatment is created for each patient after they complete surgery and while they receive adjuvant therapy. Half of the participants received their vaccine immediately after completing adjuvant treatment. The other half were given TG4050 at the time of recurrence of the disease as an additional treatment to the standard of care (SoC). This randomized study is evaluating the treatment benefits of TG4050 in patients who are at risk of relapse. The first efficacy data (2-year disease-free survival – DFS) will become available at the latest by the end of First Quarter 2028.

Announcement • Jun 22

Transgene Expands myvac® into Non-Small Cell Lung Cancer with TG4070, an Individualized Neoantigen Therapeutic Vaccine

Transgene announced the initiation of a randomized Phase 1 trial evaluating TG4070, a novel individualized immunotherapy fully designed and developed in-house by Transgene, in combination with nivolumab in the adjuvant treatment of resected non-small cell lung cancer (NSCLC). TG4070, Transgene’s second Individualized Neoantigen Therapeutic Vaccine (INTV) candidate, reflects the strategic expansion of the myvac® platform. Following TG4050, currently being evaluated in the Phase 2 part of a randomized Phase 1/2 trial in head and neck cancer (NTC4183166), TG4070 supports the expansion of the myvac® platform into NSCLC while integrating Transgene’s proprietary AI-driven neoantigen selection and cell line manufacturing capabilities. Like TG4050, it leverages Transgene’s clinically validated Modified Vaccinia Ankara (MVA) viral vector, ensuring technological consistency of the myvac® platform. This integrated proprietary ecosystem strengthens Transgene’s control over critical steps of INTV development, with an optimized manufacturing process, aiming at shortening turnaround time (compared to CEF based production), improving scalability and reproducibility, while potentially accelerating development timelines across multiple indications. SNIPER is the central component underpinning the neoantigen selection and design of TG4070. With its multiple integrated computational models, SNIPER is designed to identify and prioritize highly immunogenic neoantigens through a proprietary scoring framework, including tumor-specific expression and antigen presentation intended to optimize candidate selection and support INTV design. VacDesignR®, fully integrated into the myvac® platform, is Transgene’s patented in-house computational design engine that optimizes genetic construct for MVA vectors. This integration streamlines design process and significantly improves production reliability and vector quality – key features to achieving reliable, timely and efficient product supply. TG4070 is manufactured using a scalable and transposable cell-line based process designed to support broader deployment of INTV candidates while ensuring reliable vaccine supply. Compared with conventional CEF-based manufacturing, the optimized process enables more efficient and automated production, improved lead times and scalability. Preclinical data demonstrated comparable performance to CEF-based product, supporting continuity with existing clinical data while significantly enhancing scalability. This manufacturing evolution supports broader deployment of the myvac® platform across additional indications and larger patient populations. Transgene also plans to use cell-line based manufacturing in potential future TG4050 clinical trials. TG4050 is currently being evaluated in Phase 2 in head and neck cancer. The Phase 1 trial will evaluate the safety and tolerability of TG4070 in combination with nivolumab in resected NSCLC patients after neoadjuvant nivolumab plus chemotherapy (EUCT 2025-520946-31-00). Approximately 65% of patients do not achieve a major pathological response and remain at high risk of relapse. TG4070 is designed to stimulate the patient’s immune system to generate a targeted T-cell response against tumor-specific mutations, with the objective of recognizing and eliminating residual cancer cells and reducing the risk of disease recurrence. The candidate is in a randomized Phase 1 development in combination with nivolumab as adjuvant treatment for patients with resected non-small cell lung cancer (NSCLC) (EUCT 2025-520946-31-00). TG4050, the first candidate from the myvac® platform, continues to progress in Phase 2, with topline data expected in First Quarter 2028. Plan to move to cell-line manufacturing for potential next trials in head and neck squamous cell carcinoma.

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Transgene And NEC Corporation Report 100% Three-Year Disease-Free Survival With TG4050 And Publish Phase 1 Results In Nature Communications

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