Inovio Pharmaceuticals has signed a clinical collaboration with Roche Group’s division Genentech to evaluate the combination of its INO-5401 and INO-9012 with atezolizumab (Tecentriq) in a Phase Ib/II clinical trial to treat advanced bladder cancer.
INO-5401 is a T-cell activating immunotherapy that encodes various antigens and is designed to produce and activate T-cells to various type of cancer, while INO-9012 is an immune activator encoding IL-12 being developed to boost T-cell immune responses to INO-5401.
Genentech’s atezolizumab is a monoclonal antibody and a checkpoint inhibitor of PD-L1 expressed in tumour cells and tumour-infiltrating immune cells.
Set to start in the coming months, the multi-centre open-label trial will assess the safety, immune response and clinical efficacy of the combination in 80 patients with advanced unresectable or metastatic urothelial carcinoma (UC).
Inovio president and CEO Dr Joseph Kim said: “We believe INO-5401 has significant potential as a cancer immunotherapeutic in combination with a checkpoint inhibitor to address the high unmet medical need for advanced bladder cancer patients and to provide meaningful benefit for checkpoint inhibitor refractory patients.”
The trial will primarily recruit subjects who failed to show a meaningful response when treated with a checkpoint inhibitor alone.
The potential advantage of combining a checkpoint inhibitor with a DNA-based immunotherapeutic and T-cell activator will be evaluated in the trial.
The immunologic analyses performed during the trial are expected to offer further understanding on mechanisms of checkpoint inhibition and T-cell activation in the disease.
Image: Bladder wall thickening due to cancer. Photo: courtesy of James Heilman.