Transgene, a biotech company specializing in virus-based immunotherapies for cancer treatment, is poised to release significant clinical data for several of its lead programs before the end of 2024. These updates include key readouts from ongoing trials of TG4050, BT-001, TG4001, and TG6050, potentially marking a turning point for the company's innovative immunotherapy portfolio.
TG4050: Individualized Immunotherapy for Head and Neck Cancer
TG4050, Transgene's lead program, is an individualized immunotherapy designed for the treatment of solid tumors. The therapy is based on the myvac platform. At AACR 2024, Transgene reported initial signs of clinical benefit in adjuvant head and neck cancer, which led to the initiation of the Phase II part of a randomized Phase I/II clinical trial in Q2 2024. Notably, all patients who received TG4050 remained in clinical remission and disease-free after a median follow-up of 18.6 months, compared to a 3 out of 16 relapse rate in the observational arm during the same period. Additional data, including median 24-month follow-up results from the Phase I patients, are expected to be presented in Q4 2024. These findings will be presented at the Society for ImmunoTherapy of Cancer (SITC) annual meeting in November 2024.
BT-001: Oncolytic Virus Demonstrating Antitumor Activity
BT-001, an oncolytic virus, has shown promising antitumor activity in solid tumors that have failed previous anti-PD(L)-1 treatment. Data presented at ESMO 2024 highlighted tumor shrinkage in 2 of 6 injected lesions with BT-001 monotherapy. In combination with KEYTRUDA® (pembrolizumab), partial responses were observed in 2 of 6 patients who had previously failed treatment, with tumor shrinkage also seen in non-injected lesions. BT-001 was well tolerated both alone and in combination with pembrolizumab. Furthermore, BT-001 treatment induced T cell infiltration and a shift to PD(L)-1 positivity in the tumor microenvironment, turning “cold” tumors into “hot” tumors.
TG4001: Therapeutic Cancer Vaccine for HPV-Positive Cancers
Transgene has completed the enrollment of 90 patients in the ongoing randomized Phase II trial evaluating TG4001 in HPV-positive anogenital cancers. Topline readouts from this trial are expected in Q4 2024. The trial was launched based on promising results from a previous Phase I/II trial, which showed that TG4001 in combination with avelumab is safe and demonstrated antitumor activity in heavily pretreated HPV16-positive cancer patients.
TG6050: Intravenous Oncolytic Virus for Non-Small Cell Lung Cancer
Initial Phase I data are expected in Q4 2024 from TG6050, a novel Invir.IO® oncolytic virus candidate administered intravenously. TG6050 is designed to express human IL-12 and an anti-CTLA4 antibody. The Phase I Delivir trial is evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapeutic options. Preclinical data published in the Journal for ImmunoTherapy of Cancer demonstrated that TG6050 induces tumor regression in both “hot” and “cold” murine tumor models, with amplified antitumoral activity when combined with an anti-PD1 antibody.
Financial Stability and Leadership
Transgene has confirmed financial visibility until Q4 2025, enabling the company to deliver significant news flow on its portfolio over the next 12 months. The company's leadership team has been strengthened with the appointments of Emmanuelle Dochy as Chief Medical Officer and Maurizio Ceppi as Chief Scientific Officer.
