casdozokitug (CHS-388) / Coherus Oncology - LARVOL DELTA

Preliminary Casdozokitug Activity in HCC Supports Further Exploration of IL-27 as a Treatment Target (OncLive) - "'IL-27 is an immune-modulatory cytokine that's expressed on myeloid cells, including macrophages and dendritic cells, and it plays a role in terms of dampening T-cell and natural killer [NK] effector cell function,' Daneng Li, MD, noted in an interview with OncologyLive during the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI)."

Audio • Interview

Casdozokitug Plus Atezolizumab/Bevacizumab Yields Antitumor Activity in Unresectable, Advanced HCC (OncLive) - "A triplet regimen comprised of casdozokitug (CHS-388), atezolizumab (Tecentriq), and bevacizumab (Avastin) demonstrated antitumor activity with a manageable safety profile in the treatment of patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma (uHCC), according to Daneng Li, MD."

Audio

A randomized phase 2 study of casdozokitug, an IL-27 targeting antibody, in combination with toripalimab plus bevacizumab in patients with unresectable and/or locally advanced or metastatic hepatocellular carcinoma. (ASCO 2025) - P1, P2 | "A phase 3 study of toripalimab (tori) + bevacizumab (bev) demonstrated significant improvements in efficacy (overall survival [OS], progression-free survival [PFS], and objective response rate [ORR]) compared to sorafenib (Yinghong S, et al...A phase 2 study of casdozo + atezolizumab + bev showed an acceptable safety profile and antitumor activity (ORR 38%, CR 17.2%, mPFS 8.1 mo) (Li D, et al...Pts will remain on study treatment for ≤2 years or until documented disease progression or unacceptable toxicity. Enrollment is ongoing."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IFNG • IL12A • IL23A

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

SRF388-201: Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=134 | Active, not recruiting | Sponsor: Coherus Biosciences, Inc. | Trial completion date: May 2026 ➔ Jun 2025

Trial completion date • Hepatocellular Cancer • Oncology • Solid Tumor

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION IMMUNO-ONCOLOGY PIPELINE (Coherus Press Release) - "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."

Enrollment status • P2 data • Hepatocellular Cancer

Dr Li on the Casdozokitug/Atezolizumab/Bevacizumab in Unresectable HCC (OncLive) - "Daneng Li, MD...discusses findings from a phase 2 trial (NCT05359861) evaluating casdozokitug (CHS-388) in combination with atezolizumab (Tecentriq) and bevacizumab (Avastin) in patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC)."

Video

Coherus BioSciences Reports Fourth Quarter, Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Casdozokitug:...Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC opened for enrollment."

Enrollment open • Hepatocellular Cancer

Results from a phase 2 study of triplet blockade of the IL-27, PD-(L)1, and VEGF pathways with casdozokitug (casdozo, CHS-388) in combination with atezolizumab and bevacizumab in patients with unresectable, locally advanced or metastatic hepatocellular carcinoma (uHCC). (ASCO-GI 2025) - P1, P2 | "Funded by Coherus BioSciences Clinical Trial Registration Number: NCT05359861 Background: Casdozo is the first in class and only clinical-stage IL-27 targeting antibody, which induces increased serum IFN-γ and NK cell gene activation, leading to reversal of IL-27-mediated immune suppression. Triplet blockade of IL-27, PD-(L)1, and VEGF pathways with casdozo/atezo/bev continues to show a manageable safety profile with promising antitumor activity in uHCC that warrants continued exploration. Toxicity was consistent with the known profiles of the agents, with no new safety signals identified. Biomarker analysis to evaluate immune response and associations of IL-27 pathway and clinical outcomes is ongoing."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • IFNG

Coherus Presents Final Phase 2 Clinical Casdozokitug Combination Data in Patients with Metastatic Hepatocellular Carcinoma at ASCO-GI 2025 (Coherus) - "'The treatment landscape for liver cancer, particularly for patients who are not eligible for surgery or who are metastatic, has improved in recent years thanks to immunotherapy combinations. However, there is still a clear unmet need for novel treatment options that can further improve survival without added toxicity,' said Daneng Li, M.D."

Media quote

Coherus Presents Final Phase 2 Clinical Casdozokitug Combination Data in Patients with Metastatic Hepatocellular Carcinoma at ASCO-GI 2025 (GlobeNewswire) - P2 | N=134 | NCT05359861 | Sponsor: Coherus Biosciences, Inc. | "Coherus BioSciences, Inc...announced final data from its Phase 2 open label clinical trial evaluating casdozokitug (casdozo), a selective and potent Interleukin (IL)-27-targeting antibody, in combination with atezolizumab (atezo) and bevacizumab (bev) in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC)....Encouraging early activity with casdozo/atezo/bev: RECIST v1.1: ORR of 38% (n=29) with 11 objective responses, including 5 complete responses and 6 confirmed partial responses; median progression-free survival (PFS) of 8.1 months and disease control rate of 58.6%. mRECIST: ORR of 43% (n=28) with 12 objective responses, including 5 complete responses and 7 confirmed partial responses; median PFS of 8.4 months and disease control rate of 60.7%."

P2 data • Hepatocellular Cancer

Coherus to Present Final Phase 2 Casdozokitug Combination Data in Patients with Metastatic Hepatocellular Carcinoma at ASCO-GI 2025 (GlobeNewswire) - "Coherus BioSciences, Inc...today announced that an abstract highlighting final clinical and biomarker data from its Phase 2 clinical trial evaluating casdozokitug (casdozo), a selective and potent IL-27-antagonistic antibody, in combination with atezolizumab (atezo) and bevacizumab (bev) in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC), has been selected for a poster presentation at the upcoming 2025 ASCO GI Annual Meeting, being held January 23-25, 2025, in San Fransisco, CA."

P2 data • Hepatocellular Cancer

CHS-388-202: A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Coherus Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

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

Casdozokitug (casdozo, CHS-388), a first-in-class IL-27 antagonistic antibody, as monotherapy in treatment-refractory non-small cell lung cancer (NSCLC) (ESMO-IO 2024) - P1 | "Clinical trial identification NCT04374877. Biomarker data confirmed casdozo-mediated pharmacodynamic activity and immune activation. These findings support further evaluation of casdozo in pts with PD-1 experienced squamous NSCLC; a phase 1b study of casdozo with the anti-PD-1 inhibitor toripalimab is ongoing."

IO biomarker • Monotherapy • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CD8 • IFNG

Focus on Immuno-Oncology Portfolio and Key Upcoming Milestones (GlobeNewswire) - "The Company plans to: Initiate a Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in first-line (1L) HCC in Q4 2024; Announce final data from its Phase 2 trial of casdozokitug/atezolizumab/bevacizumab in 1L HCC in Q1 2025; and Report data from its Phase 1 study of casdozokitug/toripalimab in second to fourth line (2-4L) NSCLC in 1H 2025."

P1 data • P2 data • Trial status • Hepatocellular Cancer • Non Small Cell Lung Cancer

Casdozokitug, a first-in-class, anti-IL27 antagonistic antibody, promotes NK and T cell driven antitumor response in a phase I study in patients with advanced solid tumors (SITC 2024) - P1, P2 | "Additionally, the activity and safety of casdozokitug in combination with atezolizumab and bevacizumab in patients with untreated locally advanced or metastatic HCC is being explored in a phase 2 trial (NCT05359861). Taken together, these findings provide evidence that blockade of IL-27 signaling represents a novel and promising strategy to treat patients with NSCLC, HCC and other advanced solid tumors. Casdozokitug is currently being evaluated in combination with toripalimab (anti-PD-1) in PD-(L)1 R/R NSCLC patients and evaluation in combination with toripalimab and bevacizumab in HCC patients is planned."

Clinical • IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • IFNG • IL12A • IL23A

A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Coherus Biosciences, Inc.

Combination therapy • Metastases • New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Coherus BioSciences Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "ADVANCEMENT OF PROMISING IMMUNO-ONCOLOGY PIPELINE: (i) This quarter, the Company expects to open a Phase 2 randomized study evaluating casdozokitug, an immune regulatory IL-27 antagonist in combination with toripalimab and bevacizumab for the treatment of unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) in treatment-naive patients; (ii) The Company also anticipates final data from its Phase 2 trial of casdozokitug combined with atezolizumab and bevacizumab in first-line HCC in the first quarter of 2025."

New P2 trial • P2 data • Hepatocellular Cancer

Casdozokitug, a first-in-class, anti-IL27 antagonistic antibody treatment promotes NK and T cell activation and inflammatory response in Phase I study of cancer patients with advanced solid tumors. (CRI-ENCI-AACR ICIC 2024) - P1, P2 | "Additionally, the activity and safety of casdozokitug in combination with atezolizumab and bevacizumab in patients with untreated locally advanced or metastatic HCC is being explored in a phase 2 trial (NCT05359861). These findings provide evidence that blockade of IL-27 signaling represents a novel and promising strategy to treat patients with NSCLC, HCC and other advanced solid tumors. Casdozokitug is currently being evaluated in combination with toripalimab (anti-PD1) in PD-(L)1 R/R NSCLC patients."

Clinical • IO biomarker • Metastases • P1 data • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • IFNG

Coherus BioSciences Reports Second Quarter 2024 Financial Results and Provides Business Update (Coherus Press Release) - "A Phase 2 study evaluating casdozokitug...in combination with toripalimab and bevacizumab in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma is expected to begin enrolling patients in Q4 2024...Research and development (R&D) expenses were $22.0 million and $23.3 million for the three months ended June 30, 2024 and 2023, respectively, and $50.4 million and $57.4 million for the six months ended June 30, 2024 and 2023, respectively....The decrease for the six-month period was partially offset by the net $6.8 million charge in the first quarter of 2024 associated with the full write-off of the outlicense intangible asset and associated release of the CVR liability related to NZV930, obtained in the Surface Oncology, Inc. acquisition."

Commercial • New P2 trial • Hepatocellular Cancer • Liver Cancer

Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=134 | Active, not recruiting | Sponsor: Coherus Biosciences, Inc. | Trial completion date: Mar 2025 ➔ May 2026 | Trial primary completion date: Mar 2024 ➔ May 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=134 | Active, not recruiting | Sponsor: Coherus Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Results from a phase 2 study of triplet blockade of the IL-27, PD-(L)1, and VEGF pathways with casdozokitug (casdozo, SRF388) in combination with atezolizumab (atezo) and bevacizumab (bev) in patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma (uHCC). (ASCO-GI 2024) - P1, P2 | "Clinical Trial Registration Number NCT05359861 Sponsored by Surface Oncology Background: Casdozo is the first in class and only clinical-stage IL-27 targeting antibody, which neutralizes IL-27 in the tumor microenvironment and stimulates antitumor response. Triplet blockade of the IL-27, VEGF, and PD-(L)1 pathways with casdozo/atezo/bev has an acceptable safety profile to date with promising antitumor activity in uHCC that warrants continued exploration. Toxicity was consistent with the known profiles of the agents, with no new safety signals identified. Biomarker analysis to evaluate immune response and associations of IL-27 pathway and clinical outcomes is ongoing."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • IFNG

Coherus Presents Positive Phase 2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2024 ASCO GI Cancers Symposium (GlobeNewswire) - P2 | N=134 | NCT05359861 | Sponsor: Coherus Biosciences, Inc. | "These data are being presented at the 2024 ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024....Triplet combination treatment was well tolerated with side effect profile consistent with known adverse event (AE) profiles of atezo/bev. Encouraging early activity with casdozo/atezo/bev: (i) RECIST v1.1: ORR of 38% (n=29) with 11 durable objective responses including 3 complete responses and 8 partial responses (1 unconfirmed); median progression-free survival of 8.1 months and disease control rate of 58.6%; (ii) mRECIST: ORR of 43% (n=28) with 12 durable objective responses including 3 complete responses and 9 partial responses (1 unconfirmed); median progression-free survival not reached and disease control rate of 60.7%."

P2 data • Hepatocellular Cancer