FibroGen Announces Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate FibroGen's Immuno-Oncology Assets, FG-3165 (anti-Galectin 9) and FG-3175 (anti-CCR8), in Combination with LIBTAYO® in Upcoming Clinical Trials

Core Insights - FibroGen is collaborating with Regeneron Pharmaceuticals to evaluate two monoclonal antibodies, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO®, for treating select solid tumors [1][2][3] Group 1: Clinical Trials and Collaborations - FG-3165 targets Galectin-9 (Gal9), which suppresses T and NK cell activation, while FG-3175 targets CCR8, a receptor over-expressed on T regulatory cells in solid tumors [2][5][6] - Both FG-3165 and FG-3175 have shown complementary mechanisms of action with PD-1 inhibitors in preclinical studies, suggesting potential for improved clinical outcomes when combined with LIBTAYO® [1][2][5] - FibroGen will sponsor Phase 1 trials for both monotherapy and combination treatments, with Regeneron providing the drug supply [3] Group 2: Regulatory Developments - The FDA has cleared the Investigational New Drug (IND) application for FG-3165, with plans to initiate a Phase 1 trial in select solid tumors in the second half of 2024 [4][5] - An IND submission for FG-3175 is anticipated in 2025 [4][6] Group 3: Company Overview - FibroGen is focused on developing novel therapies in cancer biology, with other products in development including Pamrevlumab for pancreatic cancer and Roxadustat for anemia in chronic kidney disease [7] - The company is expanding its research portfolio to include immuno-oncology candidates targeting solid tumors [7]