FibroGen(FGEN) Newsfilter·2025-03-28 11:00Core Insights - FibroGen, Inc. announced the publication of a Phase 1 study of FOR46 (FG-3246), an immune-modulating antibody-drug conjugate targeting CD46, in patients with metastatic castration-resistant prostate cancer (mCRPC) [1][2] Group 1: Study Overview - The Phase 1 study was a multi-center, first-in-human, open-label dose escalation and expansion study evaluating safety, tolerability, and anti-tumor activity in 56 heavily pre-treated patients [3][6] - The study showed FG-3246 had an acceptable safety profile with the most frequent adverse events being infusion-related reactions (48.2%), neutropenia (41.1%), and peripheral neuropathy (32.1%) [6][9] - The confirmed objective response rate was 20% with a median duration of response of 7.5 months, and the disease control rate was 80% [6][9] Group 2: Future Development Plans - The company plans to initiate a Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC by mid-2025 [4][5] - Topline results from a combination trial of FG-3246 and enzalutamide are expected in the second half of 2025 [4][11] Group 3: Background on mCRPC - Prostate cancer is the second most common malignancy in men, with approximately 13% of men diagnosed during their lifetime [10] - There are about 65,000 drug-treatable mCRPC cases in the U.S. annually, with a 5-year survival rate of approximately 30% [10] Group 4: About FG-3246 - FG-3246 is a potential first-in-class fully human antibody-drug conjugate targeting CD46, which is present at high levels in prostate cancer and other tumor types [11] - The drug is currently in an ongoing Phase 1/2 study at UCSF, evaluating it in combination with enzalutamide, with topline data expected in the second half of 2025 [11] Group 5: Company Overview - FibroGen, Inc. focuses on developing novel therapies in cancer biology and anemia, with Roxadustat approved in multiple countries for treating anemia in chronic kidney disease [12]