Coherus BioSciences (CHRS) Earnings Call Presentation

CHS-114 Overview - CHS-114 is a highly selective anti-CCR8 mAb with the potential to augment I-O therapy by depleting Treg-mediated tumor immune suppression[16] - CHS-114 specifically binds and preferentially depletes CCR8+ tumor Tregs, with no off-target binding[17,23] - Preclinical data shows that anti-CCR8 with anti-PD-1 treatment demonstrates antitumor activity and a significant increase in tumoral CD8+ T cells[27,29] - In vitro data shows CHS-114 demonstrates dose-dependent Treg depletion and activation of NK and myeloid cells[37] Clinical Trial Design and Results - The Phase 1/1b study is an open-label single-agent and combination dose trial evaluating CHS-114 in patients with advanced solid tumors and HNSCC, with safety and tolerability as the primary endpoint[50,63] - In the monotherapy dose escalation (Stage 1a), 20 patients with advanced solid tumors were enrolled and evaluated seven dose levels (5 mg – 1200 mg) of CHS-114[54] - In HNSCC patients, treatment-emergent adverse events (TEAE) were observed in 85.7% of patients receiving CHS-114 monotherapy (n=14) and 100% of patients receiving CHS-114 + Toripalimab (n=7)[68] - One heavily pretreated PD-1 refractory patient with HNSCC treated with CHS-114 (DL6) + Toripalimab achieved a confirmed partial response with a 40% reduction in target lesions[73,88] Biomarker Analysis and Conclusions - CHS-114 administration leads to a substantial increase in CD8+ T cells in the TME, providing a strong rationale for combining with other drugs such as T cell engagers and bispecifics[102] - In on-treatment tumor biopsies, CHS-114 depleted CCR8+ Tregs and increased CD8+ T cells in the TME, indicating favorable TME remodeling and establishing proof of mechanism[102]