UTRECHT, The Netherlands– InteRNA Technologies, a clinical-stage biotech company developing microRNA (miRNA)-based therapeutics with a focus on cancer, announced today it received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the company’s Phase I clinical trial evaluating lead miRNA candidate, INT-1B3, in patients with advanced solid tumors. INT-1B3 is a lipid nanoparticle (LNP) formulated, chemically modified mimic of the endogenous tumor suppressor, miR-193a-3p, and represents a promising novel therapeutic approach that is designed to simultaneously address multiple hallmarks of cancer.
The IND approval enables InteRNA to expand the number of clinical sites and to facilitate the enrollment of patients for the dose expansion (Phase Ib) part of the trial in the United States. The first part of the Phase I trial was initiated in Europe at the beginning of 2021, with the dosing of the first patient in the dose escalation (Phase Ia) part in February. The treatment of the first patient in the Phase Ib cohort is planned for the second half of 2022.
“Receiving such a positive outcome from the FDA shortly after submitting a full IND application is a major achievement for us,” commented Laurens van Pinxteren, Chief Operating Officer of InteRNA. “It underlines the high potential of our novel miRNA-based approach that enables us to address the multi-facetted disease cancer from different angles with one drug providing a novel therapeutic entity to patients with hard-to-treat solid tumors, such as advanced breast cancer or hepatocellular carcinoma.”
Roel Schaapveld, CEO of InteRNA, added: “The IND approval enables us to enroll an international, diversified patient population, marking significant progress in the clinical evaluation of our novel therapeutic modality. The rapid, positive feedback by the FDA is highly encouraging and we look forward to start patient recruitment in the United States next year.”
The multicentric, open-label, multiple ascending dose Phase I/Ib trial (NCT04675996) 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 up to 15 clinical centers in the United States and Europe. The Phase Ia part of the trial is currently ongoing in the Netherlands and Belgium and will enroll approximately 30 patients with advanced solid tumors. In the second part (Phase Ib) of the trial, approximately 50 patients with hepatocellular carcinoma or triple negative breast cancer will be enrolled in the United States and Europe. Topline results from the Phase Ia part of the study are expected in the first half of 2022.