Just – Evotec Biologics, Inc., the biologics segment of Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO), announced today that cGMP clinical materials manufactured for FibroGen were cleared for clinical use by the United States Food and Drug Administration (“FDA”) as part of FibroGen’s Investigational New Drug (“IND”) filing. FibroGen aims to begin enrollment of their Phase I clinical trial evaluating the safety and efficacy of FG-3165 in patients with solid tumors characterized by high Gal9 levels of expression in the second half of 2024. Their proprietary FG-3165, a galectin-9 (“Gal9”) targeted monoclonal antibody (“mAb”) is under development for the treatment of solid tumors.

The announcement follows a product development collaboration between Just – Evotec Biologics and FibroGen. Just – Evotec Biologics has supported the pre-clinical and clinical development of FG-3165 with manufacture of Toxicology material and cGMP material for the upcoming Phase I clinical trial.

Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just – Evotec Biologics, commented: “We are proud to continue our support for FibroGen’s Gal9 mAb as their promising FG-3165 oncology program approaches clinical validation. Our highly intensified antibody manufacturing platform, J.POD®, provides flexibly scalable biologics manufacturing solutions to broaden access to innovative therapeutic options.”

Rahul Rajan Kaushik, Senior Vice President of Pharmaceutical Development, Manufacturing and Supply Chain at FibroGen, said: “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. Our meaningful partnership with Just – Evotec Biologics allows us to explore the potential of FG-3165 in enhancing anti-tumor immune responses in a clinical setting.”

About FibroGen’s FG-3165
FG-3165 is a galectin-9 (“Gal9”) targeted antibody under development by FibroGen 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.

Toxicology material as well as cGMP material for the upcoming Phase 1 clinical trial was manufactured in partnership with Just – Evotec Biologics.