Transgene has entered into collaboration agreement with Merck KGaA and Pfizer under which it will sponsor an early-stage study testing a potential new combination treatment for head and neck cancer.
The Phase I trial will evaluate its therapeutic vaccine candidate TG4001 together with Merck and Pfizer's immunotherapy avelumab for the treatment of human papilloma virus (HPV)-positive head and neck squamous cell carcinoma (HNSCC), after failure of standard therapy.
The combination of TG4001 and avelumab aims to target two distinct steps in the immune response to target cancer cells, the firms noted.
Transgene's chief executive Philippe Archinard noted that in previous clinical trials TG4001 has demonstrated promising activity in terms of HPV viral clearance and was well tolerated.
"TG4001 is one of the few drugs targeting HPV-associated cancers that can be combined with an immune checkpoint blocker such as avelumab. The preclinical and clinical data that have been generated with both TG4001 and avelumab individually suggest this combination could potentially demonstrate a synergistic effect, delivering a step up in therapy for HPV-positive HNSCC patients," he said.
The trial is expected to begin in France, recruiting patients in the first half of the 2017 with recurrent and/or metastatic virus-positive oropharyngeal squamous cell carcinoma that have progressed after definitive local treatment or chemotherapy, and cannot be treated with surgical resection and/or re-irradiation.
"HPV-induced head and neck cancers are currently treated with the same regimen as non-HPV-positive HNSCC tumours. However, their different etiology clearly suggests that differentiated treatment approaches are needed for HPV-positive patients," said Professor Christophe Le Tourneau, head of the Early Phase Program at Institut Curie and principal investigator of the study.
"Immunotherapy, and in particular the therapeutic vaccine TG4001 together with the PD-L1 blocker avelumab, by targeting two distinct steps in the immune response, could deliver improved efficacy for patients who have not responded to or have progressed after a first line of treatment," he noted.