tagmokitug (CHS-114) / Coherus Oncology - LARVOL DELTA

Coherus Oncology, Inc…announced today a clinical supply agreement with Johnson & Johnson to evaluate tagmokitug (CHS-114), Coherus Oncology’s investigational anti-CCR8 cytolytic monoclonal antibody, in combination with pasritamig, a T-cell engaging bispecific antibody, in a Phase 1b clinical study in patients with metastatic castration-resistant prostate cancer (mCRPC). (Coherus Press Release) - "Under the terms of the clinical supply agreement, Johnson & Johnson will provide pasritamig to Coherus, who will be the sponsor of the Phase 1b clinical trial. Johnson & Johnson and Coherus each retain all commercial rights to their respective compounds, including as monotherapy or as combination treatments."

Commercial • Castration-Resistant Prostate Cancer

CHS-114: an afucosylated anti-CCR8 monoclonal antibody that selectively depletes intratumoral Treg cells and induces antitumor immune responses. (PubMed, Mol Cancer Ther) - P1 | "Treatment of tumor bearing human CCR8 knock-in (huCCR8KI) mice with CHS-114 resulted in significant tumor growth inhibition (62.6%) accompanied by remodeling of the tumor immune microenvironment and enhanced differentiation of a subset of cytotoxic CD8+ T cells. Based on the promising preclinical data, we are evaluating CHS-114 in clinical trials as an investigational agent for the treatment of solid tumors with and without the anti-PD-1 antibody toripalimab (NCT05635643, NCT06657144)."

Journal • Oncology • Solid Tumor • CCR8 • CD8

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE (Coherus Press Release) - "A Phase 1b study evaluating the CHS-114/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in mid-2026. A Phase 1b/2a study evaluating CHS-114/toripalimab combination in 4L+ colorectal cancer is enrolling patients and initial data is expected in 2H 2026."

P1 data • P1/2 data • Colorectal Cancer • Esophageal Squamous Cell Carcinoma

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE (Coherus Press Release) - "Updated biomarker data from the Phase 1b study dose expansion study in 2L+ head and neck squamous cell carcinoma (HNSCC) will be presented on Saturday, November 8, 2025 at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). Phase 1b CHS-114/toripalimab combination dose optimization studies in 2L HNSCC and 2L gastric cancers are underway, with initial data readouts for HNSCC expected in 1H 2026."

P1 data • Gastric Cancer • Squamous Cell Carcinoma of Head and Neck

Coherus Oncology Presents at SITC Clinical Multiomic Biomarker Data for CHS-114, a Highly Selective anti-CCR8 Cytolytic Antibody (GlobeNewswire) - "Immune profiling of blood from HNSCC participants from 2 pharmacologically active doses of CHS-114 monotherapy expansion arm (n=10) and in combination with toripalimab safety arm (n=6) showed: CHS-114 demonstrated robust depletion of target CCR8+ Tregs and spared non-CCR8+ Tregs, CD4+ T cells and CD8+ T cells in PBMCs from HNSCC participants throughout the treatment cycle....mmune profiling of pretreatment and on-treatment tumor tissue tumor tissue samples from HNSCC participants from monotherapy expansion (n=10) and combination with toripalimab (n=2) cohorts showed: CHS-114 treatment decreased CCR8+ Treg density by 74% and total FOXP3+ Treg density by 43%, while sparing CCR8- Tregs demonstrating selective and robust depletion of target Tregs."

Biomarker • P1 data • Squamous Cell Carcinoma of Head and Neck

CHS-114, an anti-CCR8 cytolytic monoclonal antibody demonstrates selective intratumoral Treg depletion and favorable immune remodeling in participants with advanced solid tumors. (SITC 2025) - P1 | "An ongoing Phase 1 (NCT05635643), single-agent and toripalimab (tori) combination dose escalation/expansion study is evaluating CHS-114 in advanced solid tumors and head and neck squamous cell carcinoma (HNSCC). Remarkably, the tumor biopsy data indicate that CHS-114 administration converts cold tumors to immunologically 'hot' thereby supporting evaluation with immune agents beyond PD-1 inhibitors such as T cell engagers and CAR-T cell therapy.Trial Registration NCT05635643Ethics Approval The protocol and informed consent forms were reviewed and approved by an institutional review board (IRB), and the study was conducted in accordance with Good Clinical Practice. All participants provided informed consent before initiation of any study procedures."

IO biomarker • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CCR8 • CD8

Coherus Oncology Announces Poster Presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "In addition, CHS-114 will be featured in the upcoming Targets for Cancer IO: A Deep Dive live webinar series: Development of Anti-CCR8 Ab - Mechanisms and Clinical Results."

Clinical data • Solid Tumor

CHS-114-102: A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=154 | Recruiting | Sponsor: Coherus Oncology, Inc. | N=72 ➔ 154

Enrollment change • Solid Tumor

Coherus Oncology Reports Second Quarter 2025 Financial Results and Provides Business Update (Coherus Press Release) - "Phase 1b CHS-114/toripalimab combination dose optimization studies in 2L head and neck (HNSCC) and 2L gastric cancers are underway, with initial data readouts expected in 1H 2026. A Phase 1b study evaluating the CHS-114/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in 1H 2026....Enrollment is ongoing in the Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC, with the first data readout expected in 1H 2026."

P1 data • P2 data • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Hepatocellular Cancer • Squamous Cell Carcinoma of Head and Neck

Coherus Completes Strategic Transformation to Coherus Oncology, Focusing Exclusively on Innovative Cancer Therapeutics (GlobeNewswire) - "Coherus Oncology, Inc...formerly named Coherus BioSciences Inc., announced its name change today to better align with its exclusive focus on proprietary innovative immuno-oncology medicines."

Commercial • Oncology

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION IMMUNO-ONCOLOGY PIPELINE (Coherus Press Release) - "The Company initiated a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L HNSCC in Q1 2025 with a first data readout expected in Q2 2026; The Company initiated a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L gastric cancer in Q1 2025 with a first data readout expected in Q2 2026."

P1 data • Trial status • Gastric Cancer • Squamous Cell Carcinoma of Head and Neck

CHS-114-102: A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Coherus Biosciences, Inc. | N=72 ➔ 40

Enrollment change • Solid Tumor

CHS-114-102: A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Coherus Biosciences, Inc. | N=40 ➔ 72

Enrollment change • Solid Tumor

Coherus Presents Promising Early Clinical Data from Phase 1 Dose Expansion Study of CHS-114 in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma at AACR 2025 (GlobeNewswire) - P1 | N=87 | NCT05635643 | Sponsor: Coherus Biosciences, Inc. | "CHS-114 monotherapy demonstrated Treg cell depletion (range of decrease: 52-97%), and significant increase in CD8+ T cells in the tumor, establishing proof of mechanism and confirming the doses are pharmacologically active. CHS-114 with toripalimab had promising antitumor activity in HNSCC that warrants continued exploration....A second-line HNSCC dose optimization study of CHS-114 in combination with toripalimab in HNSCC and gastric cancer patients is ongoing, with anticipated results in the first half of 2026 The current study design is expected to address the regulatory requirements under Project Optimus and support the recommendation of a phase 2 dose by early 2026."

P1 data • Gastric Cancer • Squamous Cell Carcinoma of Head and Neck

Phase 1 study of anti-CCR8 antibody CHS-114 with and without anti-PD-1 antibody toripalimab in patients with advanced solid tumors (AACR 2025) - P1 | "CHS-114 with and without tori had an acceptable safety profile, depleted CCR8+ Tregs and increased CD8 T cells in the TME in pts, supporting further evaluation of CHS-114 in combination with other drugs including tori. Updated safety, efficacy, tumor biopsy and biomarker data will be presented."

Clinical • IO biomarker • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CCR8 • CD8

CHS-114-102: A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Coherus Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

SRF114-101: Study of CHS-114 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=87 | Recruiting | Sponsor: Coherus Biosciences, Inc. | N=47 ➔ 87

Enrollment change • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Coherus to Present Data from a Phase 1 Dose Expansion Study of CHS-114, a Cytolytic Antibody Targeting Chemokine Receptor 8 (CCR8), at the 2025 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Coherus BioSciences...announced 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 Annual Meeting..."

P1 data • Squamous Cell Carcinoma of Head and Neck

Coherus BioSciences Reports Fourth Quarter, Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Coherus expects to: (i) Report Phase 1 monotherapy biopsy data as well as CHS-114/toripalimab combination safety data in head and neck squamous cell carcinoma (HNSCC) in 1H 2025; (ii) Report first data for Phase 1b CHS-114/toripalimab combination dose optimization study in 2L HNSCC in Q2 2026; (iii) Initiate a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L gastric cancer in Q1 2025 with a first data readout expected in Q2 2026."

P1 data • Trial status • Gastric Cancer • Squamous Cell Carcinoma of Head and Neck

Coherus Announces Agreement to Divest UDENYCA Franchise for up to $558 million to Intas Pharmaceuticals Ltd. (GlobeNewswire) - "Coherus BioSciences, Inc...announced that it has entered into an asset purchase agreement (the Agreement) dated December 2, 2024, with Intas Pharmaceuticals Ltd. (Intas) for the divestiture of the UDENYCA (pegfilgrastim-cbqv) franchise for up to $558.4 million....Coherus to focus exclusively on innovative immuno-oncology programs that include LOQTORZI, an FDA approved, next-generation programmed cell death protein 1 (PD-1) inhibitor; Proceeds to fund development of key combination programs with LOQTORZI, including casdozokitug, a first-in-class, clinical-stage interleukin-27 (IL-27) antagonist, and CHS-114, a highly selective chemokine receptor 8 (CCR8) antibody."

Commercial • Clear Cell Renal Cell Carcinoma • Hepatocellular Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer

Focus on Immuno-Oncology Portfolio and Key Upcoming Milestones (GlobeNewswire) - "Coherus plans to: Report Phase 1 monotherapy biopsy data as well as CHS-114/toripalimab combination safety data in head and neck squamous cell carcinoma (HNSCC) in 1H 2025; Initiate a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L head and neck squamous cell carcinoma (HNSCC) in Q1 2025 with a first data readout expected in Q2 2026; and Initiate a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L gastric cancer in Q1 2025 with a first data readout expected in Q2 2026."

P1 data • Squamous Cell Carcinoma of Head and Neck

CHS-114, an anti-CCR8 cytolytic monoclonal antibody that preferentially depletes intratumoral Tregs and induces antitumor immune responses (SITC 2024) - P1 | "In a Phase 1 clinical study (NCT05635643), CHS-114 treatment of cancer patients resulted in robust depletion of peripheral CCR8+ Tregs and an acceptable safety profile. Conclusions Selective depletion of intratumoral CCR8+ Tregs with CHS-114 resulted in robust antitumor activity by reshaping the TME towards a proinflammatory milieu in preclinical studies, providing rationale for an orthogonal approach to checkpoint inhibition for eliciting antitumor immunity and evaluating CHS-114 in combination with other IO agents, such as toripalimab for the treatment of cancer."

IO biomarker • Melanoma • Oncology • Solid Tumor • CCR8

Coherus BioSciences Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "ADVANCEMENT OF PROMISING IMMUNO-ONCOLOGY PIPELINE:...(i) A Phase 1 study evaluating CHS-114, a highly selective cytolytic anti-CCR8 antibody, is ongoing. In the first half of 2025, Coherus expects to report Phase 1 data from expansion cohorts evaluating CHS-114 as monotherapy and in combination with toripalimab in patients with advanced/metastatic head and neck squamous cell carcinoma (HNSCC); (ii) Coherus plans to initiate Phase 1b dose optimization studies of CHS-114 in combination with toripalimab in patients with HNSCC and gastric cancer in the first quarter of 2025, with initial data for both studies expected in the first half of 2026."

New P1 trial • P1 data • Trial status • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Coherus Biosciences, Inc.

New P1 trial • Oncology • Solid Tumor

CHS-114, an anti-CCR8 antibody that selectively depletes intratumoral Treg cells, induces antitumor immune responses (CRI-ENCI-AACR ICIC 2024) - P1 | "Furthermore, in vitro studies using human PBMCs treated with the combination of CHS-114 and toripalimab (anti-PD-1 mAb) elicited a stronger immune activation than single agent treatments. Altogether, selective depletion of intratumoral CCR8+ Treg cells results in robust antitumor activity by reshaping the TME toward a more pro-inflammatory milieu, providing an orthogonal approach to checkpoint inhibition for eliciting antitumor immunity and a strong rationale for evaluating CHS-114 as a therapeutic agent for the treatment of cancer. CHS-114 is currently in Phase 1 clinical studies (NCT05635643) and preliminary data shows the depletion of CCR8+ Treg cells, as well as an acceptable safety profile, in cancer patients following CHS-114 administration."

IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CCR8 • CD4 • CD8 • FOXP3