Transgene, a biotech company specializing in virus-based immunotherapies for cancer treatment, has announced promising results from its Phase I trial of TG4050, a neoantigen individualized therapeutic cancer vaccine, in patients with head and neck cancer. The data, presented at SITC 2024, demonstrate a robust clinical proof of principle for TG4050 in the adjuvant setting, addressing a patient population at high risk of relapse.
TG4050: Individualized Neoantigen Therapy
The Phase I trial results showed that all 16 patients treated with TG4050 after completing adjuvant standard of care remained disease-free after a median follow-up of 24.1 months. This compares favorably to the observational arm, where 3 out of 16 patients relapsed. The study also demonstrated that all patients treated with TG4050 developed specific immune responses against the selected personalized antigen targets, indicating strong immunogenicity of the cancer vaccine. These immune responses were sustained over a 7-month period, covering the induction and boost phases.
Transgene has initiated the Phase II part of the expanded Phase I/II trial (NCT04183166) to further investigate TG4050 in the adjuvant treatment of head and neck cancer, with patient enrollment progressing well. TG4050 is currently the only individualized neoantigen cancer vaccine being developed in a randomized trial for adjuvant treatment of head and neck cancer.
BT-001: Oncolytic Virus Shows Efficacy
Transgene and its partner BioInvent presented preliminary Phase I/IIa data for BT-001 (NCT04725331) at ESMO. The data indicated that BT-001 induced tumor regression in patients who had previously been unresponsive to anti-PD(L)-1 treatment. This was observed both as a monotherapy and in combination with MSD’s pembrolizumab. BT-001 replicated within the tumor and expressed GM-CSF and anti-CTLA-4 transgenes, modulating the tumor microenvironment and inducing T cell infiltration.
TG6050: Intravenous Oncolytic Virus
The Phase I Delivir trial (NCT05788926), evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapies, has completed the first two dose levels. Initial data are expected in H1 2025. Preclinical data published in the Journal for ImmunoTherapy of Cancer demonstrated that TG6050 induces tumor regression in various murine tumor models, with amplified antitumoral activity when combined with an immune checkpoint inhibitor.
Financial Update
Transgene reported cash, cash equivalents, and other financial assets of €14.0 million as of September 30, 2024. The company confirms financial visibility into Q4 2025, enabling continued progress and news flow on its immunotherapy portfolio.
