Date: 2015-12-16
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: PsiOxus Therapeutics (UK)
Product: enadenotucirev and pembrolizumab
Action
mechanism: immunotherapy product/oncolytic virus/monoclonal antibody/immune checkpoint inhibitor. Enadenotucirev (chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions) is a chimeric oncolytic vaccine. It is currently undergoing phase I/II testing in platinum-resistant ovarian cancer patients across multiple UK cancer centres. The OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) phase I/II clinical trial aims to assess the safety and efficacy of PsiOxus’ novel oncolytic vaccine. Enadenotucirev is also under investigation in two further European clinical studies in patients with colorectal cancer, bladder cancer, non small cell lung cancer and renal cancer. Keytruda® (pembrolizumab - MK-3475) is an investigational, highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system.
Disease: solid tumors including metastatic colorectal cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The Study of Pembrolizumab In Combination with Enadenotucirev (SPICE) study aims to assess the ability of enadenotucirev to reverse resistance to checkpoint inhibitors for certain tumour types, including metastatic colorectal cancer.
Latest
news: * On December 16, 2015, PsiOxus Therapeutics has initiated a study to assess the safety and efficacy of a therapy combining Merck’s Keytruda® (pembrolizumab) and PsiOxus’ lead product, enadenotucirev, to treat patients with carcinomas. The Study of Pembrolizumab In Combination with Enadenotucirev (SPICE) study aims to assess the ability of enadenotucirev to reverse resistance to checkpoint inhibitors for certain tumour types, including metastatic colorectal cancer. The study will involve several leading clinical centres in the United States and is planned to run until 2017. Initially, the SPICE study will explore the safety of this combination therapy.
