Transgene and NEC Present New Data Confirming Clinical Proof of Principle for Neoantigen Cancer Vaccine, TG4050, in Head & Neck Cancer at SITC 2024

• Compelling 24.1-month median follow-up data presented at SITC 2024 showed that all patients treated with TG4050 after completion of an adjuvant standard of care remain disease-free
• TG4050 induced specific and sustained immune responses. A Phase II part is now enrolling patients internationally to build on this promising outcome

Strasbourg, France & Tokyo, Japan, November 7, 2024, 5:45 p.m. CET — Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, today announced 24.1-month median follow-up data from the ongoing randomized Phase I trial of TG4050 in the adjuvant treatment of head and neck cancers. The data will be presented in a poster at the Society for ImmunoTherapy of Cancer (SITC) 2024 Annual Meeting on November 9 in Houston, TX.

TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac® platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection.

After a median follow up of 24.1 months, all 16 patients who received TG4050 as adjuvant immunotherapy after completion of adjuvant standard of care remain disease-free and have not relapsed. Out of the 16 patients in the control observation arm, 3 patients have relapsed. There remains a high medical need for these head and neck cancer patients, as approximately 30% of them are expected to experience a relapse within 24 months after standard surgery and adjuvant chemoradiotherapy.

Immune responses targeting selected neoantigens were identified in 100% of patients who received TG4050, demonstrating the strong immunogenicity of the cancer vaccine, with both de novo and amplified responses. An analysis over 7 months also shows that immune responses are sustained, during the induction and boost periods.

All treatment-related adverse events continue to be mild to moderate.

Building on these promising data, the randomized Phase I trial has been expanded to a randomized Phase I/II trial in the adjuvant setting of head and neck cancer (NCT04183166), which is currently enrolling patients in the Phase II part.

Pr. Le Tourneau, MD, PhD, Head of the Department of Drug Development and Innovation (D3i) at Institut Curie, and Principal Investigator, said: “There remains a significant unmet medical need in head and neck cancer patients in the adjuvant setting. It is therefore highly encouraging to see confirmation of TG4050’s clinical and immune response data after a median follow-up of 24.1-months. TG4050 has demonstrated its potential to prime an adaptive immune response against tumor antigens and prevent relapse in patients with locally advanced resected head and neck squamous cell carcinoma (HNSCC).”

Emmanuelle Dochy, MD, Chief Medical Officer of Transgene, added: “We are very encouraged to observe that all the patients treated with our neoantigen cancer vaccine TG4050 remain disease-free after a median follow-up of 24.1 months. Looking at these results and at the long-lasting immune response, we are confident that TG4050 has the potential to benefit these patients, who still face a significant risk of relapse with current therapies. The Phase II part of our trial is currently enrolling patients internationally, with the aim of further confirming these promising findings.”

Motoo Nishihara, Corporate EVP and CTO, at NEC, added: “These results illustrate the power of our collaboration with Transgene and our ability to develop a personalized approach to cancer patient treatment using our proprietary artificial intelligence and machine learning models. We have built a strong and compelling clinical data set to support the benefits of TG4050 as an individualized immunotherapy, and we remain committed to bringing novel AI-based treatments to patients across the globe.”

Poster details:

Title: Randomized phase I trial of adjuvant individualized TG4050 vaccine in patients with locally advanced resected HPV-negative head and neck squamous cell carcinoma (HNSCC)

• Abstract Number: 650
• Session: Clinical Trial In Progress
• Date: Saturday, Novembre 9, 2024
• Presenting Author: Prof. C. Le Tourneau, MD, PhD—Institut Curie

The SITC poster can be viewed in-person during the poster presentation at the SITC2024 meeting and can be accessed on Transgene’s website.