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Agreements

Date: 2017-06-01

Type of information: Clinical research agreement

Compound: INO-5401,  INO-9012 and atezolizumab

Company: Inovio Pharmaceuticals (USA - PA) Roche (Switzerland)

Therapeutic area: Cancer - Oncology

Type agreement: clinical research

Action mechanism:

  • immunotherapy product/monoclonal antibody/immune checkpoint inhibitor.
  • Atezolizumab is a monoclonal antibody designed to make cancer cells more vulnerable to the body’s immune system by interfering with a protein called PD-L1. PD-L1 is found on the surface of cells in tumours and is believed to act as a “stop sign,” preventing the immune system from destroying cancer cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells. MPDL3280A is being studied in clinical trials to understand whether blocking PD-L1 will help the immune system respond to cancer.
  •  INO-5401 includes Inovio’s SynCon® antigens for WT1, hTERT and PSMA and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development. WT1 was at the top of the list. The hTERT antigen relates to 85 percent of cancers, and WT1 and PSMA antigens are also widely prevalent in many cancers.
  • Inovio’s INO-5401 is designed to generate and activate T-cells to many cancer types including bladder cancer. INO-9012, an immune activator encoding IL-12, is designed to amplify and accelerate T cell immune responses to INO-5401.
  • Combining INO-5401/INO-9012 with atezolizumab may provide a synergistic therapeutic effect as a result of generating higher levels of activated T cells and simultaneously inhibiting PD-L1.

Disease: advanced bladder cancer, specifically advanced unresectable or metastatic urothelial carcinoma

Details:

  • • On  June 1, 2017, Inovio Pharmaceuticals announced a clinical collaboration with Genentech, a member of the Roche Group, for advanced bladder cancer. The phase 1b/2 immuno-oncology trial will evaluate Genentech’s atezolizumab (Tecentriq®) in combination with Inovio’s INO-5401, a T cell activating immunotherapy encoding multiple antigens, and INO-9012, an immune activator encoding IL-12.
  • The multi-center open-label trial will be managed by Inovio, and Genentech will supply atezolizumab. It is anticipated to start in 2017 and designed to evaluate the safety, immune response and clinical efficacy of the combination therapy in approximately 80 patients with advanced bladder cancer, specifically advanced unresectable or metastatic urothelial carcinoma.
  • The majority of the patients to be enrolled in the trial will have previously received and failed to demonstrate meaningful response to a checkpoint inhibitor alone. Thus the study will evaluate potential benefit of a checkpoint inhibitor combined with a DNA-based immunotherapeutic and T-cell activator within a bladder cancer patient population with very limited treatment options and poor outcomes. The immunologic analyses accompanying the study will provide further insight into mechanisms of checkpoint inhibition and T-cell activation in bladder cancer.

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