On June 3, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate FibroGen’s immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron’s anti-PD-1 therapy, LIBTAYO (cemiplimab), in patients with solid tumors (Press release, FibroGen, JUN 3, 2024, View Source [SID1234644006]).

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"We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors," said Deyaa Adib, M.D., Chief Medical Officer of FibroGen. "We believe that the mechanisms of action for both FG-3165 (anti-Gal9) and FG-3175 (anti-CCR8) have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients. We look forward to building a collaborative relationship with Regeneron, who is a leader in oncology therapeutic products development and commercialization."

FG-3165 targets Gal9, which binds multiple immune checkpoints on lymphocytes that suppress T and natural killer (NK) cell activation. FG-3175 targets CCR8, a receptor frequently over-expressed on T regulatory cells in solid tumors. Both FG-3165 and FG-3175 have demonstrated complementary mechanisms of action with PD-1 inhibitors preclinically, and the Company believes that combining LIBTAYO with either FG-3165 or FG-3175 may result in added clinical benefit for patients.

Under the clinical study collaboration and supply agreement, Regeneron will provide drug supply to FibroGen, who will be the sponsor of each Phase 1 monotherapy and combination trial. Each company retains all rights to their respective compounds, including as a monotherapy or as combination therapies.

Earlier today, FibroGen separately announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for FG-3165 in patients with solid tumors. An IND submission for FG-3175 is anticipated in 2025.

About FG-3165
FG-3165 is a galectin-9 (Gal9) targeted antibody under development for treatment of solid tumors and potentially hematologic malignancies characterized by high Gal9 levels of expression. Gal9 has been reported to signal through multiple immune checkpoints on lymphocytes, including TIM3, VISTA, and PD-1, suppressing T and natural killer cell activation. FG-3165 selectively binds to Gal9 with high affinity and inhibits its ability to induce lymphocyte cell death, resulting in enhanced tumor cell killing. The Company plans to initiate a Phase 1 trial in select solid tumors in the second half of 2024.

About FG-3175
FG-3175 is a c-c motif chemokine receptor 8 (CCR8) targeted antibody under development for treatment of solid tumors highly infiltrated by CCR8-positive T regulatory cells (Tregs). CCR8 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating Tregs across different tumor types. FG-3175 is designed to deplete CCR8 Tregs via antibody dependent cellular cytotoxicity (ADCC) in the tumor microenvironment and enhance anti-tumor T cell responses, leading to enhanced anti-tumor activity and potentially improved clinical outcomes for patients in tumors such as Breast, Colorectal, Ovarian and Melanoma. In addition to its ADCC activity FG-3175 also disrupts CCR8 signaling, potentially providing additional benefit by disrupting Treg proliferation and migration into the tumor. The Company plans to submit an Investigational New Drug (IND) application for FG-3175 in 2025.