CHS-114 / Coherus Oncology - LARVOL DELTA

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

Coherus Presents Preliminary Results from Phase I Dose Escalation Study of its Anti-chemokine receptor 8 (CCR8) Antibody, CHS-114, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - P1 | N=47 | NCT05635643 | Sponsor: Coherus Biosciences, Inc. | "Coherus BioSciences...announced clinical data from the CHS-114, single agent dose escalation stage of its Phase 1 study at the ASCO Annual Meeting....CHS-114 has demonstrated an acceptable safety profile in 20 evaluable, heavily pre-treated patients with advanced solid tumors, with no DLTs reported to date. Treatment emergent adverse events (TEAEs) were generally low grade. One patient experienced a treatment-related serious adverse event (SAE) of Grade 2 colitis. There were no treatment related adverse events (AEs) leading to discontinuation or death....In 19 patients evaluable for response, no objective responses were yet noted, while the stable disease rate was 47%."

P1 data • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Preliminary results of a phase 1, first-in-human, dose escalation study of the anti-CCR8 cytolytic antibody, CHS-114 (formerly SRF114) in patients with advanced solid tumors. (ASCO 2024) - P1 | "CHS-114 an afucosylated mAb that binds CCR8, depletes itTregs, and enhances toripalimab- (tori; anti-PD-1 mAb) mediated T cell activation. CHS-114 has an acceptable safety profile to date in heavily pretreated pts at doses up to 700 mg. CHS-114 administration at 100 to 700 mg shows robust decreases in peripheral CCR8+ Tregs following the first dose (cycle 1). Dose escalation is ongoing."

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

Coherus Announces Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "Coherus BioSciences, Inc...today announced the first presentation of clinical data for CHS-114, a highly selective cytolytic anti-CCR8 antibody, at the upcoming ASCO Annual Meeting, which will be held from May 31 to June 4, 2024, at McCormick Place in Chicago."

P1 data • Solid Tumor

CHS-114: a cytolytic anti-CCR8 antibody that depletes tumor-infiltrating regulatory T cells as a treatment for head and neck squamous cell carcinoma. (MHNCS 2024) - P1 | "Together data from this study provides strong evidence that specific depletion of CCR8 + itTregs could be used as an attractive treatment approach as monotherapy and with current immunotherapies for HNSCC. CHS-114 depletes CCR8 + itTreg cells and activates a proinflammatory immune response in the HNSCC TME and in mouse tumor models, supporting its clinical development for cancer treatment. CHS-114 is currently being evaluated in a Phase 1 clinical trial."

IO biomarker • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CCR8 • CD8 • FOXP3 • IFNG

Study of CHS-114 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=47 | Recruiting | Sponsor: Coherus Biosciences, Inc. | Phase classification: P1/2 ➔ P1 | N=70 ➔ 47

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

CHS-114: Data from phase 1 of P1/2 trial (NCT05635643) for advanced solid tumors in H1 2024 (Coherus) - Corporate Presentation

P1 data • Head and Neck Cancer • Oncology • Solid Tumor

Anti-CCR8 antibody CHS-114 (SRF114) depletes tumor-infiltrating regulatory T cells in dissociated tumors from patients with head and neck squamous cell carcinoma (SITC 2023) - P1/2 | "Molecular epidemiology studies highlight HNSCC as a tumor type with a high prevalence of CCR8+ itTregs to evaluate the anti-tumor activity of an anti-CCR8 antibody. CHS-114 (SRF114) is currently being evaluated in a Phase 1 clinical trial (NCT05635643)."

Clinical • IO biomarker • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CCR8 • CD8 • FOXP3 • IFNG • PD-L1

Coherus Presents Data from Next-generation Immuno-oncology Programs at 38th Annual Meeting of Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "Coherus BioSciences, Inc...today announced data from three immuno-oncology pipeline programs at the 38th Annual Meeting of SITC taking place November 1 - 5, 2023 at the San Diego Convention Center in San Diego, CA...Poster presentation data are summarized as follows: In human immune cells from peripheral blood, IL-27 induces the expression of interferon (IFN)-stimulated genes, which are associated with drug resistance in cancer; Although many known IFN-responsive genes were induced by both IFNs and IL-27 treatment, distinct gene expression was observed in different immune cell types....In multiple model systems, CHS-114, a cytolytic antibody selective for CCR8, activates natural killer (NK) cells and specifically induces NK-mediated cytotoxicity against tumor-infiltrating CCR8+ Tregs and results in the expansion of effector CD8 T cells"

Preclinical • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Surface Oncology Announces ISS and Glass Lewis Both Recommend Stockholders Vote “FOR” the Proposed Merger with Coherus BioSciences (GlobeNewswire) - "Surface Oncology...announced that both Institutional Shareholder Services ('ISS') and Glass, Lewis & Co. ('Glass Lewis') have recommended Surface stockholders vote 'FOR' the adoption of Surface’s merger agreement (the 'merger agreement') with Coherus BioSciences....As announced on June 16, 2023, the proposed mergers contemplated by the merger agreement will strengthen Coherus’ pipeline with global rights to two innovative, competitively positioned, clinical-stage assets: SRF388, the only IL-27 targeted antibody in clinical development which has demonstrated activity as a monotherapy and in combination with checkpoint inhibitors; and SRF114, a high affinity, fully human antibody demonstrated to specifically bind to CCR8."

M&A • Oncology • Solid Tumor