On March 25, 2025 Coherus BioSciences, Inc. ("Coherus," NASDAQ: CHRS), a commercial-stage innovative oncology company, reported that an abstract highlighting interim data from its ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), has been selected for a poster presentation at the upcoming 2025 AACR (Free AACR Whitepaper) Annual Meeting, being held April 25-30, 2025, at McCormick Place Convention Center in Chicago, Illinois (Press release, Coherus Biosciences, MAR 25, 2025, View Source [SID1234651400]).
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AACR 2025 Presentation Details
Title: Phase 1 study of anti-CCR8 antibody CHS-114 with and without anti-PD-1 antibody toripalimab in patients with advanced solid tumors
Lead Author: Francis Worden, M.D., University of Michigan
Abstract #: CT038
Poster Session: Phase 0 and Phase 1 Clinical Trials
Poster Section 49: Poster board 17
Date and Time: Monday, April 28, 2025, 9:00 a.m. – 12:00 p.m. CDT
About the CHS-114 Phase 1 Study
The Phase 1 study (NCT05635643) is a dose escalation, dose optimization and expansion study evaluating CHS-114 as a monotherapy and in combination with toripalimab, a next generation PD-1 inhibitor. Cohort 1a enrolled 20 patients with advanced solid tumors including 2 patients with HNSCC and evaluated multiple dose levels (5-1200 mg) of CHS-114 monotherapy. Cohort 1b evaluated two pharmacologically active doses of CHS-114 monotherapy in 12 HNSCC patients with paired tumor biopsies. Cohort 2 evaluated two pharmacologically active doses of CHS-114 with toripalimab in 7 patients. Primary objectives are to optimize the CHS-114 dose(s) for expansion and evaluate the safety of CHS-114 with toripalimab. Secondary objectives were to evaluate the safety, PK and antitumor activity of CHS-114 with and without toripalimab and assess biomarkers including changes in regulatory T cells (Tregs) and CD8+ T cells in paired tumor biopsies and other immune biomarkers.
About CHS-114
CHS-114, an afucosylated, cytolytic CCR8 monoclonal antibody, is designed to selectively target human CCR8 and preferentially kill CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) to deplete tumoral CCR8+ Tregs. In addition, treatment with CHS-114 alone reduced tumor growth in murine models, and enhanced antitumor activity was observed in combination with anti-PD-1 treatment. CHS-114 is currently being evaluated in two Phase 1 clinical trials as monotherapy with and without toripalimab in advanced solid tumors, including head and neck cancer (NCT05635643) and gastric cancer (NCT06657144).