A new target for tumor immunity!

Text|Pharmaceutical Mission Hills

On October 8, SIM0235 (SIM1811-03), an innovative anti-tumor drug independently developed by Simcere, submitted a clinical trial application to the Center for Drug Evaluation (CDE) of China National Medical Products Administration (CDE) and was accepted.

Screenshot source: CDE official website

Tumor Necrosis Factor Type 2 Receptor (TNFR2) is a member of the tumor necrosis factor receptor superfamily.

SIM0235 is an immunoglobulin G1 (IgG1) type humanized anti-TNFR2 monoclonal antibody that can specifically recognize TNFR2 expressed on the cell surface through antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent The Fc-terminal function including cell-mediated phagocytosis (ADCP) can kill the immunosuppressive cells such as TNFR2-expressing regulatory T cells (Treg) and bone marrow-derived suppressor cells.

Preclinical studies have shown that SIM0235 has high binding specificity, can effectively block the activation of NF-κB signaling pathway induced by the combination of tumor necrosis factor α (TNFα) and TNFR2, effectively inhibit the proliferation and function of Treg cells, and regulate the immune microenvironment

In the in vivo pharmacodynamic model, SIM0235 has significant anti-tumor effects in a variety of models, and has a significant combined effect with anti-PD-L1 antibodies

In terms of safety, the safety evaluation results including the toxicity study of repeated administration of GLP show that SIM0235 has high safety characteristics, and no effects on the central nervous system, respiratory system and cardiovascular system have been observed

Since the first immune checkpoint inhibitor was approved in 2011, this type of therapy has become one of the important treatments for malignant tumors, and has been upgraded to the first-line treatment for a variety of advanced malignant tumors

Simcere's application of SIM0235 is a multi-center, open phase 1 clinical study for the treatment of advanced solid tumors and cutaneous T-cell lymphoma, which will evaluate the safety, pharmacokinetics, pharmacodynamic characteristics and anti-tumor efficacy of SIM0235

Reference materials:

[1] Center for Drug Evaluation of China National Medical Products Administration.