JS201 / Shanghai Junshi Biosci - LARVOL DELTA

A bifunctional antibody targeting PD-1 and TGF-β signaling has antitumor activity in combination with radiotherapy and attenuates radiation-induced lung injury. (PubMed, Cancer Immunol Res) - "Single-cell sequencing demonstrated that JS-201 reduced fibroblast proliferation by inhibiting the TGF-β/Smad pathway and the release of neutrophil extracellular traps mediated by ROS, thereby relieving radiation-induced pulmonary fibrosis. In conclusion, the JS-201 and radiotherapy combination enhances antitumor effects while mitigating acute and chronic RILI, and it may have potential for translational investigation as a cancer treatment strategy."

Journal • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases • TGFB1

JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Trial primary completion date: Jun 2024 ➔ Dec 2024

Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Trial completion date: Jun 2023 ➔ Jun 2025 | Trial primary completion date: Jun 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

Clinical Study of JS201 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=244 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | N=174 ➔ 244

Enrollment change • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Clinical Study of JS201 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1; N=174; Recruiting; Sponsor: Shanghai Junshi Bioscience Co., Ltd.; Trial completion date: Dec 2022 ➔ Jul 2023; Trial primary completion date: Dec 2022 ➔ Jul 2023

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology • Solid Tumor

Junshi Bio first doses PD-1/TGF-β fusion protein in malignant tumors (GBI Health) - "China-based Junshi Biosciences (HKEX:1877; SSE:688180) announced first patient dosing in a Phase I clinical study for its JS201, a first-in-class fusion protein targeting programmed-death 1(PD-1) and TGF-β RⅡ. The study is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of the drug in advanced malignant tumors."

Trial status • Oncology

Clinical Study of JS201 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1; N=174; Recruiting; Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Clinical • New P1 trial • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor • PD-1 • TGFB1

JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Hunan Province Tumor Hospital

Clinical • New P2 trial • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

Junshi’s PD-1/TGF-β bi-function fusion protein nodded for trials in China (GBI Health) - "Shanghai-based biotech Junshi Biosciences (HKEX:1877; SSE:688180) announced receipt of clinical trial approval from the National Medical Products Administration for JS201. The targeted indication is advanced malign tumors. JS201 is an in-house developed fusion protein targeting programmed-death 1 (PD-1) and transforming growth factor (TGF)–β, designed to trigger an optimized anti-tumor immune response in specific solid tumors."

Non-US regulatory • Oncology

CMAB Biopharma Congratulates Partner Junshi Biosciences on NMPA Acceptance of Application for a Clinical Trial of its PD-1/TGF-β Bifunctional Fusion Protein (PRNewswire) - “CMAB Biopharma…partner Shanghai Junshi Biosciences…announced that a clinical trial application for its PD-1/TGF-β bifunctional fusion protein JS201 injection (JS201) has been accepted by National Medical Products Administration (NMPA).”

Non-US regulatory • Oncology