CVM-1118 (Foslinanib) is a new synthetic small molecule with strong anti-cancer activity, high safety margin, and multiple mechanisms of actions in targeting cancer-specific factors. In particular, CVM-1118 possesses the novel mechanism of inhibiting a unique structure known as vasculogenic mimicry (VM), which is associated with metastasis and drug-induced resistance in malignant tumors. This unique VM inhibitory effect of CVM-1118 has positioned itself as a first-in-class drug and was reported by the journal Science as “the first drug that targets vasculogenic mimicry to reach clinical trials” (Science 352: 1381-1383, 2016 “Tumor’s DIY Blood Vessels”).
As a next-generation oral anti-cancer drug, CVM-1118 has exceptional efficacy and fewer side effects than intravenous chemotherapies, and demonstrated great therapeutic potential in cancers such as breast, ovarian, colon, neuroendocrine, and liver cancers, etc. CVM-1118 has broad patent coverage worldwide and has completed Phase I clinical evaluation in the US and Asia (Taiwan). The results demonstrated the safety of the drug and the maximum tolerated dose (MTD) of CVM-1118 was determined.
Based on results of the Phase I clinical studies, CVM-1118 obtained the approval to conduct two Phase II clinical trials by both the US FDA and Taiwan FDA. One is to conduct a Phase II study to investigate the efficacy of CVM-1118 combined with sorafenib for subjects with advanced hepatocellular carcinoma (HCC); another is to investigate the efficacy of CVM-1118 in patients with advanced neuroendocrine tumors (NET).