FibroGen Announces FDA Clearance for FG-3165 IND Application for Solid Tumors

June 3, 2024 -- FibroGen, Inc. (NASDAQ: FGEN) has announced the clearance of its Investigational New Drug (IND) application for FG-3165 by the U.S. Food and Drug Administration (FDA). FG-3165 is a galectin-9 (Gal9) targeted monoclonal antibody, currently under development for treating solid tumors that exhibit high levels of Gal9 expression. 

Thane Wettig, the CEO of FibroGen, expressed satisfaction over the FDA’s clearance, stating, “The FDA’s IND clearance is an important achievement for us, and we are pleased to advance another product from our promising oncology pipeline into the clinic. To date, FG-3165 has demonstrated anti-tumor activity with improved survival in combination with other immune modulatory therapies in mouse cancer models and has shown excellent tolerability in nonclinical safety studies. We are excited to begin enrollment in a Phase 1 trial in the second half of this year and explore the potential of FG-3165 in enhancing anti-tumor immune responses in the tumor microenvironment.”

The clearance allows FibroGen to commence a Phase 1 clinical trial, focusing on the safety and efficacy of FG-3165 in patients with select solid tumors. Enrollment for the trial is expected to begin in the latter half of 2024.

FG-3165 works by targeting Gal9, an agent known to communicate through multiple immune checkpoints on lymphocytes, such as TIM3, VISTA, and PD-1, which suppresses the activation of T and natural killer cells. By selectively binding to Gal9 with high affinity, FG-3165 inhibits its ability to induce lymphocyte cell death, thereby enhancing the destruction of tumor cells.

The toxicology and Good Manufacturing Practice (GMP) materials required for the upcoming Phase 1 trial were produced in collaboration with Just-Evotec Biologics.

FibroGen, Inc. is a biopharmaceutical firm devoted to rapidly developing innovative therapies at the forefront of cancer biology. Among its other developments, Pamrevlumab is a fully human anti-CTGF monoclonal antibody in clinical trials for treating metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat, also known as 爱瑞卓® or EVRENZOTM, is approved in various regions including China, Europe, and Japan for treating anemia in chronic kidney disease (CKD) patients, both on and off dialysis. Roxadustat is undergoing clinical trials for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority. Another significant development is FG-3246 (also known as FOR46), an innovative antibody-drug conjugate (ADC) designed to target CD46, being studied for the treatment of metastatic castration-resistant prostate cancer. This program also includes developing a CD46-targeted PET biomarker.

Additionally, FibroGen is expanding its research and development portfolio to include two immuno-oncology product candidates aimed at treating solid tumors.

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