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

06-03-24 1633ET