FibroGen and Regeneron Pharmaceuticals forge clinical trial collaboration for cancer treatment

FibroGen, Inc. (NASDAQ: FGEN) has entered into a clinical trial supply agreement with Regeneron Pharmaceuticals, aiming 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. This partnership marks a significant step in cancer research, potentially leading to more effective treatments for patients suffering from various solid tumors.

Clinical Trial and Study Objectives

Under the terms of the agreement, Regeneron will supply LIBTAYO for use in the trials, while FibroGen will sponsor each Phase 1 monotherapy and combination trial. The collaboration focuses on two promising targets: FG-3165 and FG-3175, which are believed to have synergistic effects with LIBTAYO due to their unique mechanisms of action. Dr. Deyaa Adib, Chief Medical Officer at FibroGen, expressed optimism about the partnership, stating, “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.”

Details on FG-3165 and FG-3175

FG-3165 targets Gal9, a molecule known to bind various immune checkpoints and suppress immune cell activation. This antibody is designed to inhibit the function of Gal9, thereby enhancing the immune system’s ability to fight tumor cells. FibroGen plans to initiate a Phase 1 trial for FG-3165 in the latter half of 2024, following recent clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA).

On the other hand, FG-3175 targets CCR8, a receptor frequently overexpressed in T regulatory cells within solid tumors. This targeted antibody aims to deplete these immunosuppressive cells through antibody-dependent cellular cytotoxicity (ADCC), enhancing anti-tumor responses. An IND submission for FG-3175 is anticipated in 2025.

Potential Impacts and Future Prospects

The collaboration between FibroGen and Regeneron represents an exciting development in the field of oncology, with the potential to introduce new, effective cancer therapies. By combining their expertise and innovative therapies, both companies aim to address significant unmet needs in the treatment of solid tumors, with hopes to extend benefits to other conditions such as breast, colorectal, ovarian, and melanoma cancers.

Each company retains all rights to their respective compounds, ensuring flexibility in the future development of these promising treatments, either as monotherapies or in combination with other drugs.

This strategic alliance not only accelerates the development of novel cancer therapies but also illustrates the commitment of both FibroGen and Regeneron to advancing medical science and improving patient outcomes. As the clinical trials progress, the oncology community eagerly anticipates the potential benefits these innovative therapies may offer.