On December 1, 2020 Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the Phase I clinical study (NCT04601285) of a recombinant humanized anti-TROP2 monoclonal antibody – Tub196 conjugate (JS108), has completed the dosing of the first patient (Press release, Shanghai Junshi Bioscience, DEC 1, 2020, View Source [SID1234572162]).
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JS108 is a recombinant humanized anti-TROP2 monoclonal antibody – Tub196 Conjugate. TROP2 is an important receptor expressed at high level in a variety of solid tumors (including breast cancer, gastric cancer, non-small cell lung cancer, small cell lung cancer, colon cancer and pancreatic cancer) , implicated in promoting tumor cell proliferation, tissue invasion, and metastasis. Overexpression of TROP2 was correlated with poor prognosis clinically. In July 2020, JS108 clinical trial application was approved by the National Medical Products Administration (NMPA).
In recent years, antibody drug conjugates (ADCs) targeting cell surface receptors expressed on tumor cells have become treatment options for multiple cancer indications. Unlike non-specific chemotherapy, ADCs are designed to target and kill tumor cells while sparing normal healthy cells.
Junshi has entered an exclusive license agreement with Hangzhou DAC Biotech Co., Ltd. ("Hangzhou DAC"), to develop and commercialize JS108 (anti-TROP2-ADC) in Asian countries and regions excluding Japan and South Korea.
About NCT04601285 Study
NCT04601285 is an open label, first-in-human phase I clinical study to evaluate the safety, tolerability, PK profile and efficacy of JS108 in patients with advanced solid tumors. The primary endpoints for this study are safety and tolerability, while the secondary endpoints include PK profile, immunogenicity, efficacy and correlation with TROP2 protein expression level. The study consists of three stages: the dose escalation, the dose expansion, and the indication expansion. The planned enrollments in three stages are 16 to 36, 12 to 27 and 60 to 90 patients with advanced solid tumors.