IPN01195 / Ipsen, University of Montreal, IRICoR - LARVOL DELTA

Phase I/II first-in-human (FIH) study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and antitumour activity of IPN01195 as single agent in adult participants with advanced solid tumours (ESMO 2025) - P1/2 | "Legal entity responsible for the study Ipsen. Funding Ipsen."

Clinical • First-in-human • IO biomarker • Metastases • P1/2 data • PK/PD data • Oncology • Solid Tumor

The Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal and IRICoR Announce initiation of Phase 1 Trial of Licensed Small Molecule Therapy for Solid Tumors (Canada Newswire) - "IRIC and IRICoR today announced the start of a Phase 1 clinical trial of its small molecule therapy for solid tumors licensed to Ipsen. This marks a major milestone in the strategic collaboration between the partners, which began in May 2020 with a research and option agreement followed by a licensing agreement in February 2023. The small molecule clinical candidate, now known as IPN01195, is a RAF inhibitor, an important target in a signaling pathway involved in cancer cell growth and proliferation."

Trial status • Solid Tumor

Ipsen delivers strong sales in the first quarter 2025 and confirms its full-year guidance (GlobeNewswire) - "The regulatory filing for tovorafenib was accepted by EMA for review in the European Union, marking an important step forward in the development of this potential treatment for pediatric low-grade glioma and reinforcing Ipsen’s commitment to innovation in rare and difficult-to-treat cancers; Ipsen also initiated the entry in Phase I of IPN01195, a RAF inhibitor, complementing IPN01194, an ERK inhibitor, and tovorafenib, two other assets targeting the MAPK pathway."

EMA filing • Trial status • Glioma • Solid Tumor