Transgene and NEC Corporation announced positive 24.1-month median follow-up data from their Phase I trial of TG4050, an individualized immunotherapy for head and neck cancers. The results, to be presented at the Society for ImmunoTherapy of Cancer (SITC) 2024 Annual Meeting, demonstrate a sustained disease-free survival in patients receiving TG4050 as adjuvant therapy.
Clinical Efficacy and Immunogenicity
The trial data revealed that all 16 patients treated with TG4050 after standard adjuvant care remained disease-free after a median follow-up of 24.1 months. In contrast, 3 out of 16 patients in the control observation arm experienced relapse. This is clinically significant, as approximately 30% of head and neck cancer patients typically relapse within 24 months following surgery and adjuvant chemoradiotherapy.
Furthermore, the study showed that TG4050 induced robust immune responses against selected neoantigens in all treated patients. These responses, observed over a 7-month period, included both de novo and amplified immune reactions, indicating the vaccine's ability to stimulate and sustain an adaptive immune response.
TG4050: A Personalized Immunotherapy Approach
TG4050 is designed using Transgene’s myvac ® platform and NEC’s AI capabilities to optimize antigen selection, creating a personalized treatment for each patient's unique tumor profile. This individualized approach aims to enhance the precision and effectiveness of the immunotherapy.
Pr. Le Tourneau, Head of the Department of Drug Development and Innovation (D3i) at Institut Curie, emphasized the unmet need in head and neck cancer and the potential of TG4050 to prevent relapse by priming an adaptive immune response against tumor antigens.
Safety and Future Development
The treatment-related adverse events observed in the trial were mild to moderate. Building on these promising results, the trial has been expanded to a randomized Phase I/II study (NCT04183166), which is currently enrolling patients in the Phase II part to further confirm the findings.
Dr. Emmanuelle Dochy, Chief Medical Officer of Transgene, expressed confidence in TG4050's potential to benefit patients facing a significant risk of relapse with current therapies, citing the long-lasting immune response observed in the trial.
Motoo Nishihara, Corporate EVP and CTO at NEC, highlighted the collaboration's success in developing a personalized cancer treatment using AI and machine learning, underscoring their commitment to bringing novel AI-based treatments to patients globally.
