Transgene has completed initial patient screening for Phase II of its TG4050 trial for HPV-negative head and neck cancer. Phase I results showed 100% disease-free survival after two years. Randomization is expected by late 2025, with immunogenicity data in 2026 and efficacy data in 2027. Transgene is also preparing for a new clinical trial in another indication.
Transgene, a biotech firm based in Strasbourg, recently announced that they have completed the initial patient screening for the Phase II portion of their TG4050 clinical trial. The trial targets patients with operable HPV-negative head and neck cancers, and it’s being conducted across multiple centers (NCT04183166). The promising preliminary results from the earlier Phase I study showed that all participants remained disease-free after at least two years of follow-up, which is quite significant.
In the Phase I trial, 32 patients were evaluated, and they exhibited sustained T cell responses at the 24-month mark. These findings met important endpoints such as safety and immune activation and were highlighted at the recent American Society of Clinical Oncology annual meeting. Looking ahead, Transgene aims to complete the randomization of all participants by the end of 2025 following a secondary screening post-surgery and adjuvant treatments.
The company plans to enroll roughly 80 patients in total for the ongoing trial. Meanwhile, they are anticipating the first immunogenicity results from the Phase II segment sometime in the second half of 2026, while preliminary efficacy data is expected by late 2027.
Dr. Emmanuelle Dochy, Transgene’s Chief Medical Officer, stated that completing the first patient screening for Phase II marks a crucial milestone for the company. She expressed gratitude to the patients and medical staff for their contributions. Dr. Alessandro Riva, Transgene’s CEO, shared his optimism about the trial’s Phase I results, emphasizing the potential of the myvac® platform and the company’s efforts to advance TG4050 rapidly in the market.
Notably, the myvac® platform, which is tailored for individualized cancer vaccines, demonstrates promise beyond head and neck cancers, allowing Transgene to prepare for a new Phase I trial in another early treatment setting, set to begin in Q4 2025. This diversified approach underscores the company’s commitment to addressing various solid tumors where medical needs are critical.
Transgene is known for its innovative approach in immunotherapy and intends to keep leveraging AI technology to enhance vaccine development for patients. Their strategy aims to approach precision medicine more effectively by personalizing treatment for individual patients. They’re gearing up for a future with significant data readouts in the next two years, which could greatly impact cancer treatment dynamics.
Transgene has finished initial patient screening for the Phase II part of the TG4050 clinical trial, focusing on operable HPV-negative head and neck cancers. Encouraging results from the Phase I study demonstrated a 100% disease-free survival at a minimum follow-up of two years. The timeline for randomizing all patients is projected for the end of 2025, with significant immunogenicity data expected by 2026 and efficacy data by 2027. The company is expanding its research efforts into new indications as its myvac® platform shows great promise for the future.
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