Wellmarker Bio announced that on February 23, 2021 the company received approval from the Australian Therapeutic Goods Administration (TGA) for a Phase I clinical trial using WM-S1-030, a targeted anti-cancer drug for colorectal cancer and progressive cancer.

Under the approval, Wellmarker Bio will seek to recruit a total of 100 advanced cancer patients in multiple centers, including sites in Australia such as the Linear Clinical Center and Monash Hospital, to conduct clinical trials in two stages: Phase Ia (dose escalation) and Phase Ib (dose expansion). "We plan to study the drug's safety at various doses in Phase Ia, and in Phase Ib, we will conduct studies for indication expansion as well as combination therapy with chemotherapy, other targeted or cancer immunotherapy drugs along with validation of our predictive biomarker," said Dong-Hoon Jin, CEO of WMBIO.

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. Wellmarker's WM-S1-030 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. This deep understanding of the mechanism of action of WM-S1-030 means that the drug is expected to demonstrate efficacy in patients with colorectal cancer across both KRAS wild-type and KRAS mutant genotypes.

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. By using predictive biomarkers to enable efficient development of an effective precision medicine for patients who lack alternative options, WMBIO has rapidly moved its asset from exploratory research through preclinical studies and now into early clinical development in less than four years.

Since its inception in 2016, Wellmarker Bio has developed 9 first-in-class pipeline drugs, as well as predictive biomarkers for each drug candidate. 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.