The combination of TG4001 and avelumab intends to target two different steps in the immune response for targeting cancer cells.
The trial is anticipated to start 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.
Transgene designed TG4001 active immunotherapeutic to express the coding sequences of the E6 & E7 tumor-related antigens of HPV-16 and the cytokine, IL-2.
Avelumab is an investigational, fully human antibody specific for a protein identified on tumor cells called PD-L1, or programmed death ligand-1.
As a checkpoint inhibitor, avelumab is believed to have a dual mechanism of action that could potentially allow the immune system to detect and attack cancer cells.
Transgene chairman and CEO Philippe Archinard said that in earlier clinical trials TG4001 has demonstrated promising activity in terms of HPV viral clearance and was well tolerated.
Archinard said: "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.”
Image: Transgene announces collaboration with Merck and Pfizer to evaluate the combination of TG4001 with avelumab in HPV-positive head & neck cancer in a phase 1/2 study. Photo: courtesy of Merck KGaA, Darmstadt, Germany.