French Biotech Transgene and Japanese NEC Corporation have released follow-up data from the Phase I trial of its individualised cancer vaccine, TG4050, in patients with head and neck cancers.
The companies presented the positive data at the 2024 American Association for Cancer Research (AACR) Annual Meeting taking place in San Diego from 5 to 10 April. The companies also announced plans to start a randomised Phase II extension of the Phase I trial, which is slated for start in Q2 this year.
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The randomised Phase I trial (NCT04183166) enrolled 32 patients with newly diagnosed and locoregionally advanced squamous cell carcinoma of the head and neck. After a median follow-up of 18.6 months, all 16 patients in the TG4050 treatment group were disease-free while three out of the 16 patients in the control observation arm relapsed.
Specific cellular responses were seen in 16 out of 17 patients who received TG4050, the additional patient who received TG4050 was one of the relapsed participants from the control group. The treatment-induced T-cell responses were maintained for over seven months following the initiation of the treatment.
TG4050 is an individual-coded, virus-based cancer vaccine. It was developed using Transgene’s myvac technology, with the patient-specific neoantigents identified and encoded using NEC’s AI and machine learning-powered neoantigen prediction system. TG4050 stimulates the patient’s immune system to induce a T-cell response.
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According to a GlobalData report, cancer vaccines are a key immuno-oncology development trend. One of the major trends in the cancer vaccine space is mRNA-based vaccines.
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By GlobalDataGlobalData is the parent company of Clinical Trials Arena.
Multiple companies are developing cancer vaccines for different cancers. US-based Diakonos Oncology is developing a dendritic cell vaccine, DOC1021, for malignant glioma. In January, the vaccine was awarded an orphan drug designation by the US Food and Drug Administration (FDA). Sweden-based Mendus is developing its cancer vaccine, vividencel, for treating acute myeloid leukaemia. The vaccine was granted fast track designation by the FDA in September 2023.
Transgene is also developing an oncolytic virus therapy, BT-011, for treating solid tumours in partnership with BioInvent International. The therapy is being evaluated in a Phase I/IIa clinical trial (NCT04725331) as a single agent and in combination with Merck & Co (MSD)’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab).
