On March 7, 2024 Tianjin Jiancheng Biopharma reported the company registered a Phase II/III, randomized, multicenter, open study on the Drug Clinical Trial Registration and Publicity Platform for the treatment of patients with previously untreated locally advanced, unresectable or metastatic PD-L1 and CD73 selective non-small cell lung cancer (NSCLC) with ulelimumab (CD73 monoclonal antibody) combined with toripalimab (PD-1), toripalimab alone, and pembrolizumab alone (Press release, TJ Bio, MAR 7, 2024, View Source [SID1234654000]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The study plans to recruit 450 subjects in China, aiming to confirm the superiority of ulelimumab combined with toripalimab in prolonging PFS compared with pembrolizumab treatment. The main researchers include Professor Wu Yilong of Guangdong Provincial People’s Hospital. Ulelimab is an innovative humanized antibody targeting the CD73 target, independently developed by I-Mab. By binding to a new antigen epitope of the CD73 dimer molecule, Ulelimab can effectively inhibit the enzymatic activity of CD73 in a non-substrate competitive manner, reduce the production of adenosine, promote T cell activity and tumor suppression effect. At the 2023 ASCO (Free ASCO Whitepaper) conference, I-Mab announced the positive research results of the Phase Ib/II clinical trial (NCTO4322006) of the combination therapy of ulelimumab and toripalimab for the first-line treatment of advanced NSCLC. Among newly diagnosed NSCLC patients, 31% responded to the combination therapy; among patients with high CD73 expression and PD-L1 positive, 63% responded to the combination therapy.