Globenewswire·2025-12-10 17:00Core Insights - GENFIT reports encouraging preliminary Phase 1b data for GNS561 in combination with a MEK inhibitor for treating advanced KRAS mutated cholangiocarcinoma (CCA) [1][6] Clinical Trial Context and Objective - CCA is a rare and aggressive bile duct cancer with limited treatment options and poor prognosis [2] - GNS561 is an investigational small molecule targeting PPT1, aiming to inhibit autophagy and promote cancer cell death [2] - The ongoing Phase 1b study evaluates the safety and tolerability of GNS561 combined with trametinib, a MEK inhibitor, in patients who have failed prior therapies [2] Preliminary Results - The analysis included 9 patients, with 4 reaching tumor assessment at week 6, showing disease control and tumor reduction [3][6] - Disease stabilization was observed in all evaluated patients, with tumor shrinkage noted in a subgroup [7] Clinical Impact - The combination of GNS561 and MEK inhibitors shows potential to address critical unmet medical needs in oncology, particularly for patients with advanced solid tumors [4] - The consistent disease stabilization and tumor shrinkage suggest meaningful clinical benefits, warranting further investigation [4] Next Development Steps - Phase 1b dose escalation will continue, with new data expected in Q1 2026 to establish recommended Phase 2 doses [8] - Phase 2 initiation is targeted for the second half of 2026 [8] About GNS561 - GNS561 is a first-in-class investigational agent with a novel mechanism of action, developed for advanced solid tumors [10] - GENFIT acquired full intellectual property rights for GNS561 in early 2025, expanding its development capabilities [10] About GENFIT - GENFIT is a biopharmaceutical company focused on rare, life-threatening liver diseases, with a history of over two decades in liver disease research [12] - The company has a diverse R&D portfolio, including therapies for cholangiocarcinoma and other serious diseases [12]