YH002 is a highly effective recombinant humanized agonistic OX40 IgG1 monoclonal antibody that exhibits potent anti-tumor activity. By mimicking the function of OX40L and binding to OX40, YH002 acts as an excellent immune-activating antibody with a unique antigen-binding epitope and a favorable safety profile.
Clinical Progress
An open-label, single-arm Phase I dose escalation study was conducted in Australia to evaluate the efficacy of YH002 alone in patients with advanced solid tumors. The preliminary results from this study, completed in June 2022, demonstrated that YH002 was both safe and effective for treating advanced solid tumors.
Trial #：YH002002
NCT #：NCT04353102
We have received the IND approvals from the NMPA and the U.S. FDA for Phase I clinical trials of YH002 as a single agent in China and the U.S..
This multicenter, open-label Phase I dose escalation study aimed to assess the safety, tolerability, and pharmacokinetics of YH002 in combination with YH001 (a CTLA-4 monoclonal antibody) among patients with advanced solid tumors. The study was conducted simultaneously in Australia and China. In July 2022, enrollment for three dose groups of YH002 combined with YH001 was completed in Australia for the YH002004 trial.
Trial #：YH002004
NCT #：NCT05169697
OX40 Target
OX40 is a type I transmembrane glycoprotein belonging to the TNFRSF family and plays an essential role as a costimulator of T cell response by enhancing TCR signaling after engagement. It promotes proliferation and survival while also releasing effector cytokines that prevent T-cell tolerance formation. Additionally, activation of OX40 inhibits the production and secretion of inhibitory cytokines such as IL-10 and TGF-b by Treg cells while contributing significantly to memory T cell formation.
There are currently no marketed OX40 drugs.
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