-- First-in-human trial will test the safety, pharmacokinetics and preliminary efficacy of microRNA therapeutic candidate INT-1B3 --
Utrecht, The Netherlands, May 6, 2020 – InteRNA Technologies announced today regulatory approvals in the Netherlands and Belgium for the initiation of the first-in-human (Phase I) clinical trial testing its lead microRNA candidate, INT-1B3, in patients with advanced solid tumors. INT-1B3 is a lipid nanoparticle (LNP) formulated, chemically modified miR-193a-3p mimic that can be delivered by systemic administration to cancer cells. Due to the ongoing COVID-19 pandemic, clinical trial initiation has been delayed and is now anticipated to start during H2 2020. The Company will provide an update once the trial has officially launched.
The study is a multicentric, open-label and multiple ascending dose clinical trial that will investigate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of INT-1B3 in patients with advanced solid tumors. The study is expected to enroll a total of up to 80 patients at 12 clinical centers in the United States and Europe. The first part of the trial is a Phase Ia dose escalation study, conducted in the Netherlands and Belgium, which will enroll approximately 30 patients with advanced solid tumors. These patients will receive INT-1B3 via infusions twice weekly in 21-day cycles. Subsequently, approximately 50 patients with either hepatocellular carcinoma or triple negative breast cancer will be enrolled in the Phase Ib dose expansion part of the trial. Initial data readout from the Phase Ia study is expected in the end of 2021.
“The multi-targeted nature of microRNAs represents a novel approach to treating a broad range of cancer indications by effectively targeting several biochemical pathways simultaneously,” said Dr. Roel Schaapveld, CEO of InteRNA Technologies. “Driven by the promise of microRNAs as a treatment modality in cancer, our understanding of the underlying mechanism of action of INT-1B3 and the identification of a delivery vehicle for optimized performance, our primary focus has been on preparing our lead candidate for first-in-human clinical trials. As such, we are truly excited to bring INT-1B3 into the clinic and to gain deeper insights on how it reacts against solid tumors.”
“INT-1B3 is a promising and novel anti-cancer approach with anti-tumor potential involving direct effects on tumor cells and modulation of the immunosuppressive tumor microenvironment leading to immune system activation,” added Prof. Dr. Emile Voest, Chairman of InteRNA’s Scientific Advisory Board and Medical Director of the Netherlands Cancer Institute in Amsterdam. “The safety profile and significant anti-tumor efficacy demonstrated in preclinical studies provide a strong basis for first-in-human studies with INT-1B3.”