FibroGen Inc ( FGEN ) shares initially traded higher Tuesday morning after the company said the FDA cleared its Investigational New Drug (IND) of FG-3165. FibroGen ( FGEN ) also announced a new clinical trial supply agreement with Regeneron.

The Details: FibroGen ( FGEN ) announced that the FDA cleared its IND of FG-3165, allowing the company to initiate a Phase 1 clinical trial.

FG-3165 is a galectin-9 targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. Phase 1 trials evaluating the safety and efficacy of FG-3165 in patients with select solid tumors are expected to begin enrollment in the second half of 2024. 

"To date, FG-3165 has demonstrated anti-tumor activity with improved survival in combination with other immune modulatory therapies in mouse cancer models and has shown excellent tolerability in nonclinical safety studies," said Thane Wettig, CEO of FibroGen ( FGEN ).

FibroGen ( FGEN ) also announced a clinical trial supply agreement with Regeneron Pharmaceuticals Inc ( REGN ) to evaluate FibroGen's ( FGEN ) immuno-oncology assets FG-3165 and FG-3175 with Reneneron's anti-PD-1 therapy LIBTAYO (cemiplimab) in patients with solid tumors.

FibroGen ( FGEN ) will be the sponsor of each Phase 1 monotherapy and combination trial. Regeneron will provide drug supply to FibroGen ( FGEN ). Each company will retain all rights to their respective compounds.

"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," said Deyaa Adib, chief medical officer of FibroGen ( FGEN ).

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FGEN Price Action: FibroGen shares were up around 14% in early trading before pulling back. The stock was down 1.63% at $1.21 at the time of publication, according to Benzinga Pro.