JS110 / Wigen Biomedicine, Shanghai Junshi Biosci - LARVOL DELTA

XPO1 inhibitor WJ01024 monotherapy or in combination with ruxolitinib in myelofibrosis (ASH 2025) - "Five patients achievedTSS50, including 1 of 1 (100%) in 20 mg monotherapy group, 1 of 2 (50%) in 40 mg monotherapy group,and 3 of 3 (100%) in 60 mg combination therapy group.ConclusionsWJ01024, as monotherapy or combined with ruxolitinib, was well tolerated, and significantly reducedspleen volume and relieved core symptoms of MF. Our study suggests that WJ01024 plus ruxolitinibwarrants further development in MF."

Combination therapy • IO biomarker • Monotherapy • Myelofibrosis • JAK2

A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis (clinicaltrials.gov) - P1/2 | N=49 | Recruiting | Sponsor: Suzhou Junjing BioSciences Co., Ltd. | N=26 ➔ 49

Enrollment change • Myelofibrosis

A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis (clinicaltrials.gov) - P1/2 | N=26 | Recruiting | Sponsor: Suzhou Junjing BioSciences Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Myelofibrosis

The Safety and Efficacy of Multiple-dose of WJ01024 in Subject With Advanced Cancer (clinicaltrials.gov) - P1 | N=23 | Terminated | Sponsor: Suzhou Junjing BioSciences Co., Ltd. | N=66 ➔ 23 | Trial completion date: Apr 2026 ➔ May 2025 | Recruiting ➔ Terminated; Due to a change in the development strategy, the sponsor decided to terminate the study on May 28, 2025

Enrollment change • Trial completion date • Trial termination • Hematological Malignancies • Oncology • Solid Tumor

A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis (clinicaltrials.gov) - P1/2 | N=26 | Not yet recruiting | Sponsor: Suzhou Junjing BioSciences Co., Ltd.

New P1/2 trial • Myelofibrosis

The Safety and Efficacy of Multiple-dose of WJ01024 in Subject With Advanced Cancer (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: Suzhou Junjing BioSciences Co., Ltd. | N=108 ➔ 66 | Trial completion date: Apr 2024 ➔ Apr 2026 | Trial primary completion date: Jul 2023 ➔ Jun 2025

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

Targeting XPO1 Combined with Radiotherapy to Enhance Systemic Anti-tumor Effects in Non-Small Cell Lung Cancer. (PubMed, Int J Radiat Oncol Biol Phys) - "Our findings suggest that WJ01024 might be a potential synergistic treatment for radiotherapy to control the proliferation of NSCLC cells, promote tumor regression and prolong survival in mouse model of NSCLC by activating cGAS/STING signaling, and this in turn potentiate the immune microenvironment."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • CGAS • GZMB • IFNG • STING • XPO1

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for JS110 (XPO1 inhibitor) (GlobeNewswire) - "Shanghai Junshi Biosciences...announced today that Suzhou Junjing Biomedical Technology Co., Ltd., a company jointly invested by Junshi Biosciences and Wigen Biomedicine Technology (Shanghai) Co., Ltd., has received a notice from the U.S. Food and Drug Administration (the 'FDA') concerning the approval of the investigational new drug ('IND') application for XPO1 inhibitor WJ01024 tablets (product code: 'JS110') by the FDA."

IND • Oncology • Solid Tumor

Junshi’s XPO1 inhibitor JS110 picks up trial nod 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 (NMPA) for pipeline candidate JS110. The drug is a small-molecule inhibitor of nuclear export protein XPO1 under development to treat advanced cancer."

Non-US regulatory • Oncology