erus BioSciences(US:CHRS)2025-04-28 21:30Coherus BioSciences (CHRS) Update Summary Company Overview - Company: Coherus BioSciences - Focus: Development of CHS-114, a cytolytic CCR8 targeting antibody for cancer immunotherapy Key Points from the Call Industry and Product Development - Phase I Study: The call discussed the Phase I study results of CHS-114 as a CCRA antibody, evaluated both as monotherapy and in combination with Torpalumab in patients with advanced solid tumors, particularly head and neck cancer [2][4] - Target: CHS-114 targets CCR8, a G protein-coupled receptor, which is selectively expressed on tumor-resident T regulatory cells (Tregs) [7][6] - Mechanism: The goal is to deplete Tregs to enhance the immune response against tumors, turning "cold" tumors "hot" by allowing CD8 T cells to infiltrate [5][6] Clinical Results - Preclinical Data: Preclinical models showed that treatment with CHS-114 led to significant depletion of Tregs and enhanced antitumor activity when combined with PD-1 inhibitors [8][9] - Patient Population: The study included patients with advanced solid tumors, primarily head and neck cancer, with a median age of around 60 years and a majority being male [23] - Safety Profile: The Phase I study demonstrated an acceptable safety profile with no dose-limiting toxicities (DLTs) and a stable disease rate of approximately 50% in heavily pretreated patients [17][25] Efficacy and Biomarker Data - Response Rates: The combination therapy showed promising results, with a notable partial response in a patient who had previously failed multiple lines of therapy [26][29] - Biomarker Analysis: Significant reductions in CCR8 positive Tregs were observed, with a decrease of 52% to 97% after treatment, indicating a shift towards a more inflamed tumor microenvironment [43][44] - Durability of Response: The combination therapy demonstrated durable responses, with ongoing evaluations to assess long-term efficacy [28][26] Future Directions - Expansion Studies: Coherus is expanding its studies to include gastric cancer, with ongoing recruitment for trials assessing CHS-114 in combination with Torpalumab [20][19] - Market Potential: The second-line treatment space for metastatic head and neck cancer is identified as an unmet medical need, with current standard treatments showing low response rates [77][78] Additional Insights - Combination Therapy: The potential for combining CHS-114 with T cell engagers and bispecific antibodies was discussed, emphasizing the importance of a robust CD8 T cell infiltrate for effective treatment [64][65] - Patient Characteristics: The responder in the study had a low PD-L1 score, suggesting that targeting Tregs may provide benefits even in patients with traditionally low immunogenicity [81][82] Conclusion - Coherus BioSciences is advancing its clinical development of CHS-114, showing promising early results in targeting CCR8 positive Tregs to enhance immune responses in cancer therapy. The ongoing studies aim to address significant unmet needs in the treatment of advanced solid tumors, particularly in head and neck cancer.