InteRNA Technologies announced today regulatory approvals in\nthe Netherlands and Belgium for the initiation of the first-in-human (Phase I)\nclinical trial testing its lead microRNA candidate, INT-1B3, in patients with\nadvanced solid tumors. INT1B3 is a lipid nanoparticle (LNP) formulated,\nchemically modified miR-193a-3p mimic that can be delivered by systemic\nadministration to cancer cells. Due to the ongoing COVID-19 pandemic, clinical\ntrial initiation has been delayed and is now anticipated to start during H2\n2020. The Company will provide an update once the trial has officially\nlaunched. <\/p>\n\n\n\n
The study is a multicentric, open-label and multiple ascending\ndose clinical trial that will investigate the safety, pharmacokinetics,\npharmacodynamics and preliminary efficacy of INT-1B3 in patients with advanced\nsolid tumors. The study is expected to enroll a total of up to 80 patients at\n12 clinical centers in the United States and Europe. The first part of the\ntrial is a Phase Ia dose escalation study, conducted in the Netherlands and\nBelgium, which will enroll approximately 30 patients with advanced solid\ntumors. These patients will receive INT-1B3 via infusions twice weekly in\n21-day cycles. Subsequently, approximately 50 patients with either\nhepatocellular carcinoma or triple negative breast cancer will be enrolled in\nthe Phase Ib dose expansion part of the trial. Initial data readout from the\nPhase Ia study is expected in the end of 2021. <\/p>\n\n\n\n
\u201cThe multi-targeted nature of microRNAs represents a novel\napproach to treating a broad range of cancer indications by effectively\ntargeting several biochemical pathways simultaneously,\u201d said Dr. Roel\nSchaapveld, CEO of InteRNA Technologies. \u201cDriven by the promise of microRNAs as\na treatment modality in cancer, our understanding of the underlying mechanism\nof action of INT1B3 and the identification of a delivery vehicle for optimized\nperformance, our primary focus has been on preparing our lead candidate for\nfirst-in-human clinical trials. As such, we are truly excited to bring INT-1B3\ninto the clinic and to gain deeper insights on how it reacts against solid\ntumors.\u201d <\/p>\n\n\n\n
\u201cINT-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,\u201d added Prof. Dr. Emile Voest, Chairman of InteRNA\u2019s Scientific Advisory Board and Medical Director of the Netherlands Cancer Institute in Amsterdam. \u201cThe safety profile and significant anti-tumor efficacy demonstrated in preclinical studies provide a strong basis for first-in-human studies with INT-1B3.\u201d<\/p>\n\n\n\n