CanWell’s TLR7 Agonist CAN1012 Received IND Approval by CDE in China

Canwell announced today that its TLR7 agonist CAN1012 had obtained clinical trial approval from China’s Center for Drug Evaluation (CDE). The approval allows CanWell to conduct Phase I clinical trials targeting advanced solid tumors in China. Prior to this, CAN1012 had obtained Phase I clinical trial approval from the US Food and Drug Administration (FDA) and Phase I clinical trial in the US is currently ongoing.

The CAN1012 Phase I clinical trial is an open-label, multicenter, dose-escalation, and dose-expansion study aimed at evaluating the safety, tolerability, and preliminary efficacy of the drug in late-stage solid tumor patients as a single agent, and determining the maximum tolerated dose and recommended Phase II dose. Currently, the study is being conducted simultaneously in China and the United States.

CAN1012 is a highly selective small-molecule TLR7 agonist developed by CanWell with global intellectual property rights. Preclinical studies have shown that it has high selectivity and potency, with low toxicities. It can exert sustained stimulation of the target cells in the tumor microenvironment, transforming “cold” tumors with low immune response into “hot” tumors with augmented immune response, playing a crucial bridging role in the innate and adaptive immune systems. In addition, it may be administered in combination with various drugs such as immunotherapy checkpoint inhibitors, as well as radiotherapy and chemotherapy, to produce highly synergistic effects.