WM-S1: Slated to go into Phase 1b Study in 2022

Wellmarker Bio (WMBIO) has recently announced that its lead asset, WM-S1-030, a novel targeted anticancer drug for colorectal cancer and progressive cancer is scheduled to enter the Phase 1b study in the fourth quarter of 2022.

WMBIO is currently recruiting more than 100 patients in multiple centers in Australia including the Linear Clinical Center and Monash Hospital. WM-S1, which has been approved by the Australian Therapeutic Goods Administration (TGA) for Phase I clinical trial on February 19, 2021, is conducted in 2 parts; a dose-escalation (1a) and a dose-expansion (1b).

WM-S1-030 Phase I Candidate Treatment (Sample)

For Phase 1a study, patient's biomarkers are being analyzed retrospectively and the evaluation of the safety and tolorability of the oral administration is under way. For Phase 1b study, patient's biomarkers will be analyzed prospectively and selection of appropriate patient groups will be preceded. This 1b study is designed for indication expansion (e.g., Cholangiocarcinoma, NSCLC, Pancreatic Cancer, and Head & Neck cancer), colon cancer patients, and combinational approaches (with immunotherapeutic antibody, PD-1).

WM-S1-030 has demonstrated tumor growth inhibition in colorectal cancer model that are resistant to Erbitux (generic name: cetuximab), an anti-cancer drug commonly used as a targeted therapy in 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. Currently there is a significant unmet need for patients displaying primary and secondary resistance to Erbitux, which could allow WM-S1-030 to be positioned as a first-in-class drug.

IND Submission planned for WM-A1

WMBIO's second lead asset, WM-A1 is a novel therapeutic antibody with immunotherapeutic effects in NSCLC(Non-Small Cell Lung Cancer). WM-A1 has demonstrated high immunotherapeutic efficacy in PBMC (Peripheral Blood Mononuclear Cell) humanized model for NSCLC patients with low and negative PD-L1 tumors. The company has identified Mechanism of Action and has established analytical methods using predictive biomarkers. This program is expected to enter preclinical testing in the fourth quarter of 2021 in collaboration with Charles River Laboratories, a widely recognized CRO (Contract Research Organization). The IND filing is planned for the second half of 2022.

To date, WMBIO has signed 40 confidentiality contracts (CDA) with leading pharmaceutical companies and it is actively discussing with global pharmaceutical companies on licensing-out opportunities for the WM-S1 and WM-A1 program.