JS006 / Shanghai Junshi Biosci - LARVOL DELTA

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Coherus Biosciences, Inc. | Phase classification: P1/2 ➔ P1

Monotherapy • Phase classification • Hepatocellular Cancer • Hepatology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MET • PD-L1 • ROS1

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=22 | Terminated | Sponsor: Coherus Biosciences, Inc. | Trial completion date: Jan 2026 ➔ Jul 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Jul 2024; The study was terminated for strategic reasons (not for safety concerns)

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MET • PD-L1 • ROS1

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=22 | Active, not recruiting | Sponsor: Coherus Biosciences, Inc. | Recruiting ➔ Active, not recruiting | N=100 ➔ 22

Combination therapy • Enrollment change • Enrollment closed • Metastases • Monotherapy • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MET • PD-L1 • ROS1

Coherus Completes Surface Oncology Acquisition (GlobeNewswire) - "Coherus BioSciences, Inc...today announced the closing of the previously announced acquisition of Surface Oncology, Inc...As a result of the acquisition, Coherus’ novel I-O pipeline now includes four differentiated clinical-stage assets: Toripalimab...Casdozokitug...CHS-114...and CHS-006...At the closing of the acquisition, Coherus issued 0.1960 shares of its common stock per share of outstanding Surface common stock and certain outstanding Surface employee equity awards (which exchange ratio was calculated based on a $5.2831 per share price of Coherus common stock) for a total value equal to approximately $66.9 million, the sum of $40 million plus Surface’s net cash at closing of the transaction of $26.9 million."

M&A • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Coherus Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MET • PD-L1 • ROS1

A Study of JS009 Monotherapy and JS009 as a Triple Combination Therapy in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | N=254 ➔ 0 | Not yet recruiting ➔ Withdrawn

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial withdrawal • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Coherus Biosciences, Inc.

Combination therapy • Metastases • Monotherapy • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MET • PD-L1 • ROS1

A Study of JS009 Monotherapy and JS009 as a Triple Combination Therapy in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=254 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Combination therapy • Monotherapy • New P1 trial • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Clinical Study of TAB006 in Patients With Previously Treated, Advanced Malignancies (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | N=208 ➔ 0 | Not yet recruiting ➔ Withdrawn

Combination therapy • Enrollment change • Monotherapy • Trial withdrawal • Hematological Malignancies • Oncology • Solid Tumor

Coherus Highlights Anticipated New Product Launches and Immuno-oncology Growth Strategy at Analyst Day Event (GlobeNewswire) - "CHS-006 (anti-TIGIT antibody) is being evaluated in an ongoing clinical trial. In 2023, Coherus expects to receive clinical data informing dose-selection and is planning to enroll new patient cohorts in the United States to evaluate CHS-006 + toripalimab for treatment of several solid tumor indications that may include non-small cell lung cancer, small cell lung cancer, esophageal cancer, and hepatocellular carcinoma....Coherus expects to file investigational new drug ('IND') applications with the FDA in 2023 for CHS-1000, an antibody targeting ILT4, and in 2024 for CHS-3318, an antibody targeting CCR8....Toripalimab launch readiness is on track and will benefit from the high overlap in customer accounts between UDENYCA® and toripalimab. If approved, toripalimab will be the first and only PD-1 inhibitor registered in the United States for the treatment of advanced nasopharyngeal carcinoma."

Clinical data • Enrollment status • IND • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Clinical Study of TAB006 in Patients With Previously Treated, Advanced Malignancies (clinicaltrials.gov) - P1 | N=208 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Combination therapy • Monotherapy • New P1 trial • Hematological Malignancies • Oncology • Solid Tumor

Coherus and Junshi Biosciences Expand Immuno-Oncology Collaboration to Include TIGIT-Targeted Antibody (GlobeNewswire) - "Coherus BioSciences...and Shanghai Junshi Biosciences...announced that Coherus has initiated the process to exercise its option to license JS006, Junshi Biosciences’ TIGIT-targeted antibody, in the United States and Canada, expanding the companies’ 2021 immuno-oncology collaboration agreement. Coherus will pay Junshi Biosciences $35 million upfront, up to $255 million in development regulatory and sales milestones, and an 18% royalty on net product revenue, subject to terms and conditions agreed between the parties."

Licensing / partnership • Oncology • Solid Tumor

The Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumor (clinicaltrials.gov) - P1; N=176; Recruiting; Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Clinical • Combination therapy • Monotherapy • New P1 trial • Oncology • TIGIT

Junshi Biologics anti-cancer drug TIGIT obtains FDA approval in clinical trials in the United States [Google translation] (Eastmoney.com) - "Junshi Bio (688180.SH) announced that the company 's subsidiary TopAlliance Biosciences...has officially received US Food and Drug Administration Bureau (hereinafter referred to as FDA) regarding specific anti TIGIT monoclonal antibody injection (Project Code: TAB006 / JS006) in clinical trials for the treatment of advanced malignant tumor. Approved, clinical trials of TAB006/JS006 will be launched in the United States in the near future."

IND • Hematological Malignancies • Oncology

Coherus BioSciences to expand late-stage pipeline to immuno-oncology with in-license of Junshi Biosciences’ PD-1, toripalimab, in United States and Canada (GlobeNewswire) - "Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare and highly prevalent cancers, including non-small cell lung cancer ('NSCLC')....First U.S. BLA filing expected this year for nasopharyngeal carcinoma with breakthrough therapy designation…Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare and highly prevalent cancers, including non-small cell lung cancer (‘NSCLC’)...Under the terms of the agreement, Coherus will pay $150 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences’ anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates."

BLA • Licensing / partnership • Gastrointestinal Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology

Junshi Bio’s TIGIT mAb JS006 under trial review in US (GBI Health) - "Shanghai-based biotech Junshi Biosciences...announced a IND filing to the US FDA for JS006, an anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) monoclonal antibody (mAb). The filing was made by its subsidiary, TopAlliance Biosciences, Inc...TIGIT antibodies have already demonstrated anti-tumor efficacy as monotherapies or combined with anti-programmed death-1/ligand-1 antibodies in preliminary clinical studies. The drug also obtained a clinical nod from the National Medical Products Administration earlier this week."

IND • Non-US regulatory • Oncology

Junshi Biosciences Announces Acceptance by NMPA of its IND Application for JS006 (GlobeNewswire) - “Junshi Biosciences…is pleased to announce that the China National Medical Products Administration (NMPA) has recently accepted its Investigational New Drug (IND) application for JS006, a humanized monoclonal antibody against a human lymphocyte inhibitory receptor TIGIT.”

Non-US regulatory • Oncology

Junshi Bio’s TIGIT mAb JS006 under clinical review in China (GBI Health) - "Shanghai-based biotech Junshi Biosciences (HKEX:1877; SSE:688180) announced clinical trial filing for JS006, an anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) monoclonal antibody (mAb). The filing has been accepted for review by the National Medical Products Administration (NMPA)...Pre-clinical studies showed that JS006 specifically blocked the TIGIT-PVR inhibitory pathway while its competitive ligand CD226 bound to PVR to stimulate the activation of killer immune cells and secrete tumor killer factors."

Non-US regulatory • Preclinical • Oncology