Wellmarker Bio Co., Ltd today announced that the MFDS has cleared the Investigational New Drug (IND) application for the pipeline candidate "WM-S1-030" for the treatment of advanced colorectal and solid tumors.

This will be the second approval of WM-S1-030 after last year's Australian Therapeutic Goods Administration (TGA) and the study will be evaluated in two phases; Phase 1a and 1b.

Phase 1a will involve dose escalation to determine the maximum tolerated dose (MTD). The MTD will be determined on the basis of the results from the safety, tolerability and biomarker evaluation. Phase 1b will involve application of combination immunotherapy through biomarker-driven patient selection and dose-expansion cohort of patients with cholangiocarcinoma, head and neck cancer including colorectal cancer.

Wellmarker Bio will also unveil WM-S1-030's preclinical results as a monotherapy as well as a combination with Keytruda (pembrolizumab) at the American Cancer Society (AACR) 2022.