Anti-CD46 antibody drug conjugate (Fortis Therapeutics)
- Generic Name
- Anti-CD46 antibody drug conjugate (Fortis Therapeutics)
CD46-Targeting ADC FG-3246 Shows Promising Results in Advanced Prostate Cancer Trial
• FG-3246, a first-in-class antibody-drug conjugate targeting CD46, demonstrated an 80% disease control rate and 20% objective response rate in heavily pre-treated metastatic castration-resistant prostate cancer patients.
• The phase 1 trial established 2.7 mg/kg as the maximum tolerated dose, with manageable safety profile including neutropenia as the most common adverse event, while showing a median radiographic progression-free survival of 8.7 months.
• FibroGen plans to advance FG-3246 with a phase 2 monotherapy study by mid-2025 and will disclose results from a combination trial with enzalutamide in the second half of 2025.
AstraZeneca Acquires FibroGen China for $160 Million, Strengthening Roxadustat Position
• FibroGen has agreed to sell its China subsidiary to AstraZeneca for approximately $160 million, comprising $85 million in enterprise value plus an estimated $75 million in net cash holdings.
• The strategic sale will extend FibroGen's cash runway into 2027 and enable continued development of its oncology pipeline, including the Phase 2 trial of FG-3246 for metastatic prostate cancer.
• Upon closing in mid-2025, AstraZeneca will acquire all rights to roxadustat in China, where it leads the market for chronic kidney disease anemia treatment.
FibroGen Terminates Pamrevlumab Development After Failed Pancreatic Cancer Trials, Announces Major Workforce Reduction
• FibroGen's lead drug pamrevlumab fails to demonstrate survival benefits in two pivotal pancreatic cancer trials, leading to complete termination of the program.
• The company announces plans to reduce its workforce by 75% following the drug's failure, marking a significant setback after previous unsuccessful trials in Duchenne muscular dystrophy.
• Despite setbacks, FibroGen maintains a $215 million cash reserve and continues development of other pipeline candidates, including promising ADC therapy FG-3246 for prostate cancer.
FibroGen Highlights Pamrevlumab's Potential in Pancreatic Cancer and Roxadustat's Growth in Q1 2024 Earnings Call
• FibroGen anticipates top-line data from Phase 3 trials of pamrevlumab in metastatic and locally-advanced pancreatic cancer, addressing a significant unmet need.
• Roxadustat sales in China increased by 24% year-over-year, driven by a 39% volume increase, with potential for further growth pending approval for chemotherapy-induced anemia.
• FG-3246, a first-in-class ADC, shows promising Phase 1 results in metastatic castration-resistant prostate cancer, with plans for a Phase 2/3 study in late 2024.
• FibroGen's strong cash position of $214.7 million is expected to fund operations into 2026, supporting the advancement of its clinical programs.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath