FibroGen To Begin Trials on Tumor Treatment After FDA OK

By Ben Glickman

FibroGen can begin conducting clinical trials for its potential solid tumor treatment after regulators approved the company's application.

The San Francisco-based company said Monday that the U.S. Food and Drug Administration had granted its Investigational New Drug for FG-3165, a monoclonal antibody treatment. The company can advance to a Phase 1 trial of FG-3165, which will evaluate the safety and efficacy of the treatment in solid tumors characterized by high levels of the protein galectin-9.

The company said it planned to begin enrollment for the Phase 1 trial in the second half of the year.

FibroGen also announced a clinical trial supply deal with Regeneron Pharmaceuticals for multiple trials evaluating its assets for cancer treatment.

The company's FG-3175 asset, another antibody for solid tumor treatment, will also be evaluated.

Regeneron will provide drug supply for the trials to FibroGen. The two trials will assess each candidate as a monotherapy and in combination with Regeneron's Libtayo.

Write to Ben Glickman at ben.glickman@wsj.com

(END) Dow Jones Newswires

June 03, 2024 16:33 ET (20:33 GMT)

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