China-based biopharma RemeGen Ltd (HKG: 9995) has announced receiving approval from the US FDA to initiate a Phase I clinical study for its antibody drug conjugate (ADC) RC108 in c-Met positive advanced solid tumors. This marks a significant step forward in the global development of RC108, building on its existing clinical approval in China.
Mechanism of Action and Clinical Progress
The c-Met receptor tyrosine kinase plays a crucial role in activating various cell signaling pathways associated with cell proliferation, movement, migration, and invasion, and is linked to poor prognosis in many tumor types. RC108, composed of a c-Met targeted antibody, linker, and small molecule cytotoxic, targets and binds to c-Met-positive tumor cells to mediate the endocytosis of antibodies. This effectively delivers cytotoxic agents to cancer cells, achieving a better tumor-killing effect. RC108 received clinical approval in China in November 2020 and is currently undergoing a Phase I study in c-Met positive advanced solid tumors in the country, with controllable safety.
Future Prospects and Global Development
The FDA’s approval to initiate the Phase I clinical study in the US underscores RemeGen’s commitment to advancing RC108 on a global scale. This strategic move positions the company to address significant unmet medical needs in the treatment of c-Met positive advanced solid tumors, potentially improving patient outcomes and expanding its presence in the oncology market.-Fineline Info & Tech
