YH002 is a recombinant anti-OX40 humanized IgG1 antibody that targets the human OX40 receptor (TNFRSF4). The specificity, potency, and anti-cancer efficacy of YH002 have been demonstrated in a comprehensive panel of pre-clinical studies. The totality of pre-clinical data supports progression of YH002 in combination with YH001 into clinical studies in adult subjects with locally advanced or metastatic solid tumors. We are currently conducting a first-in-human (FIH), multicenter, open-label, Phase I dose-escalation study in Australia to evaluate the safety, tolerability, and pharmacokinetics and determine the MTD/RP2D of anti-OX40 YH002 in subjects with advanced solid malignancies.
Preliminary data from the Phase I trial have demonstrated a favorable safety profile of YH002. As of the data cut-off date of May 31, 2021, two cases of dose limiting toxicity (DLT) were observed in the 3.0 mg/kg dose group, including diarrhea and enteritis. Seven subjects (53.8%) had 23 drug-related AEs of any level, including two cases of Grade 3 SAE, such as diarrhea and enteritis, six cases of Grade 2 AEs, such as fatigue, pneumonitis, diarrhea and vomiting. There were no deaths due to drug-related AE. We have received IND approvals from the NMPA and the FDA for Phase I clinical trials of YH002 as a single agent in China and the United States.
We plan to conduct a clinical trial of anti-OX40 YH002 in combination with YH001 in patients with advanced solid tumors in China and Australia. Depending on the results of the Phase I clinical trial, we may conduct a Phase II MRCT to evaluate YH002 in combination with YH001 for the treatment of soft tissue sarcomas, small-cell lung cancer and other solid tumor indications in China, the United States, Australia and potentially, other countries or regions.