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.