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Clinical Trials

Date: 2018-08-16

Type of information: Treatment of the first patient

phase: 1-2a

Announcement: treatment of the first patient

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

Product: INO-5401, INO-9012 and atezolizumab

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 the immune checkpoint 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, atezolizumab may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.
  •  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: bladder cancer

Therapeutic area: Cancer - Oncology

Country: Spain, USA

Trial details:

  • This open-label, multi-center Phase 1/2a study plans to enroll 85 patients divided into two cohorts. Cohort A includes patients with confirmed disease progression during or following prior checkpoint inhibitor therapy, while Cohort B patients are treatment naïve and unfit for cisplatin-based therapy.
  • Primary endpoints are incidence of AEs, antigen-specific immunologic activation and objective response rate (ORR) in Cohort A.
  • Secondary endpoints are Cohort B’s ORR, duration of response, progression free survival and overall survival.
  • Exploratory endpoints are correlation of biomarkers to anti-tumor activity. A safety run-in will be performed for the first six patients enrolled in Cohort A to monitor emergence of any dose limiting toxicities.
  • INO-5401 and INO-9012 (10 mg DNA combined in 1ml) will be administered by intramuscular injection followed by electroporation every 3 weeks for first 4 doses, every 6 weeks for 6 doses and every 12 weeks until disease progression. Atezolizumab (1200 mg IV) will be administered every 3 weeks until disease progression. Tumor imaging, disease assessment (per RECIST and iRECIST) and biopsies, blood and urine samples will be collected at set time points including prior to study treatment, on treatment and at disease progression. (NCT03502785)

Latest news:

  • • On August 16, 2018, Inovio Pharmaceuticals announced that it has dosed its first patient in a Phase 1/2a study designed to evaluate the safety, immunogenicity and clinical efficacy of INO-5401, Inovio’s novel cancer immunotherapy that encodes multiple cancer antigens, plus INO-9012, a T cell activator, in combination with atezolizumab, (F. Hoffman-La Roche Ltd.) a PD-L1 inhibitor, for the treatment of advanced or metastatic bladder cancer. The trial, which is being managed by Inovio, is expected to enroll approximately 85 patients at sites located in the United States and Spain.
  • Inovi is on track and looks forward to producing interim clinical results in 2019.
 

Is general: Yes