Wellmarker Bio Co., Ltd (WMBIO), a biopharmaceutical company with fully-integrated capabilities in discovery, development of new anticancer drugs derived from comprehensive biomarker analysis, announced the first subject has been successfully dosed.
This Phase I clinical trial is an open-label, multicenter, multinational study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of WM-S1-030. The study will be conducted in 2 parts; a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). Part 1 will evaluate the safety and tolerability of the oral administration of WM-S1-030 as monotherapy in a dose ascending manner. Part 2 will further investigate efficacy, safety, PK, pharmacodynamics, and alternative dosing regimens including combination therapies.
WM-S1-030 has demonstrated significant tumor growth inhibition in colorectal cancer models that are resistant to Erbitux (generic name: cetuximab), an anti-cancer drug commonly used as a targeted therapy in solid cancers including colorectal cancer. It has so far shown outstanding therapeutic efficacy in extensive preclinical studies, including Patient-Derived tumor Cell (PDC) and Patient-Derived tumor Xenograft (PDX) animal models. The drug is expected to demonstrate efficacy in patients with colorectal cancer across both KRAS wild-type and KRAS mutant genotypes.
About Wellmarker Bio Co., Ltd.
Wellmarker Bio Co., Ltd (WMBIO) is the first company to be spun out in 2016 from the renowned Asan Medical Center, Korea’s largest hospital. WMBIO is developing a deep pipeline of first-in-class drugs as well as predictive biomarkers for indications including colon cancer, liver cancer, non-small-cell lung cancer (NSCLC) and other cancers. By utilizing a bed-to-bench discovery strategy, selecting the right patient groups with high unmet needs and building a wealth of data around the safety and efficacy of its novel drug candidates, Wellmarker Bio is moving closer to delivering individualized, effective and affordable options to patients.
This Phase I clinical trial is an open-label, multicenter, multinational study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of WM-S1-030. The study will be conducted in 2 parts; a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). Part 1 will evaluate the safety and tolerability of the oral administration of WM-S1-030 as monotherapy in a dose ascending manner. Part 2 will further investigate efficacy, safety, PK, pharmacodynamics, and alternative dosing regimens including combination therapies.
WM-S1-030 has demonstrated significant tumor growth inhibition in colorectal cancer models that are resistant to Erbitux (generic name: cetuximab), an anti-cancer drug commonly used as a targeted therapy in solid cancers including colorectal cancer. It has so far shown outstanding therapeutic efficacy in extensive preclinical studies, including Patient-Derived tumor Cell (PDC) and Patient-Derived tumor Xenograft (PDX) animal models. The drug is expected to demonstrate efficacy in patients with colorectal cancer across both KRAS wild-type and KRAS mutant genotypes.
About Wellmarker Bio Co., Ltd.
Wellmarker Bio Co., Ltd (WMBIO) is the first company to be spun out in 2016 from the renowned Asan Medical Center, Korea’s largest hospital. WMBIO is developing a deep pipeline of first-in-class drugs as well as predictive biomarkers for indications including colon cancer, liver cancer, non-small-cell lung cancer (NSCLC) and other cancers. By utilizing a bed-to-bench discovery strategy, selecting the right patient groups with high unmet needs and building a wealth of data around the safety and efficacy of its novel drug candidates, Wellmarker Bio is moving closer to delivering individualized, effective and affordable options to patients.