CanWell’s TLR7 Agonist CAN1012 IND Granted Approval by US FDA

CanWell Pharma announced that its First-in-Class innovative drug, TLR7 agonist CAN1012, has been granted clinical approval by the US Food and Drug Administration (FDA) and will soon conduct Phase I clinical trials for various solid tumors.

CAN1012 is an innovative Toll-like receptor (TLR) 7 small molecule agonist independently developed by CanWell with global intellectual property rights. It is a sustained-release injection with high selectivity, high activity, and excellent physicochemical characteristics. Through sustained stimulation in the tumor microenvironment, CAN1012 can transform non-immune responsive “cold” tumors into immune responsive “hot” tumors, playing a crucial bridging role in both innate and adaptive immune systems, and enabling the body’s own immune system to recognize and attack tumor cells. In addition, it has a strong potential synergistic effect with various anti-cancer therapies, such as tumor immunotherapy checkpoint inhibitors. By locally releasing the drug, CAN1012 can effectively reduce adverse reactions caused by systemic immune system activation, making the drug safer and more effective.