China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the enrollment of the first patient in a Phase I clinical study for its novel anti-tumor drug candidate SIM0235 (formerly SIM1811-03) in the United States. This marks a significant milestone in the global development of the drug.
SIM0235: Mechanism and Potential
SIM0235 is a monoclonal antibody (mAb) targeting tumor necrosis factor receptor 2 (TNFR2), which is selectively expressed in a variety of tumors and promotes the proliferation of tumor cells. The drug is designed to kill immunosuppressive cells expressing TNFR2 and regulate the immune microenvironment through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP). Additionally, SIM0235 can block the activation of endogenous tumor necrosis factor α (TNF-α) to TNFR2, affecting the TNFR2-mediated immunosuppressive function and the proliferation of regulatory T cells. This mechanism enhances the body’s anti-tumor immune response.
Safety Profile and Clinical Progress
SIM0235 has demonstrated a good safety profile under explored dosages in a Phase I study conducted in China. The initiation of the US Phase I trial is an important step in further evaluating the drug’s safety and efficacy in a broader patient population, paving the way for potential global use in treating various types of tumors.-Fineline Info & Tech
