GWN323 PK from the FIH study was described by a population PK model; the relationship with ex vivo interleukin-2 release, a target-engagement marker, was also modeled. The clinical PK/PD modeling data supported the biological active dose projected from the translational PK/PD modeling in a "learn and confirm" paradigm of model-informed drug development of GWN323.

over 3 years ago

Journal • IO biomarker

IL2 (Interleukin 2)

GWN323

over4years

First-in-human phase I/Ib open-label dose-escalation study of GWN323 (anti-GITR) as a single agent and in combination with spartalizumab (anti-PD-1) in patients with advanced solid tumors and lymphomas. (PubMed, J Immunother Cancer)

GWN323, as a single agent and in combination, was well tolerated in patients with relapsed/refractory solid tumors. The MAD was 1500 mg q3w for single-agent and GWN323 750 mg+spartalizumab 300 mg q3w for combination treatments. Minimal single-agent activity and modest clinical benefit were observed with the spartalizumab combination.

over 4 years ago

Clinical • P1 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker

CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha)

spartalizumab (PDR001) • GWN323