On December 22, CSPC Pharmaceutical Group (1093.HK) announced that the investigational new drug (IND) application for NBL-020, a fully human antibody drug independently developed by NovaRock Biotherapeutics Limited (NovaRock), a subsidiary of the group, has been approved by the U.S. Food and Drug Administration (FDA) and can be used to conduct clinical trials in the United States for the treatment of advanced solid tumors.
NBL-020 is a fully human monoclonal antibody against tumor necrosis factor type 2 receptor (TNFR2). TNFR2 belongs to the tumor necrosis factor receptor (TNFR) superfamily and maintains the immunosuppressive microenvironment of tumor cells through multiple signaling pathways , directly or indirectly promoting tumor progression. It stimulates multiple immunosuppressive cell types, including regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSCs), and acts as an oncogene . The use of TNFR2 antibodies to inhibit highly suppressive Tregs and MDSCs in the tumor microenvironment is expected to become a new strategy for the treatment of advanced solid tumors.
NBL-020 was discovered and developed by NovaRock's proprietary AFIS technology platform. Preclinical studies have shown that NBL-020 has good safety, high affinity for target cells and potent anti-tumor activity. In both PD-1-sensitive and PD-1-resistant syngeneic animal models, NBL-020 inhibited tumor growth and prolonged survival as a single agent or in combination with anti-PD1 antibodies. Although PD-1/PD-L1 inhibitors have made significant breakthroughs in the treatment of solid tumors, there are still a large number of unmet medical needs for PD-1/PD-L1-resistant/refractory tumors. NBL-020 offers potential advantages in the treatment of cancers that are resistant and refractory to anti-PD-1/PD-L1 checkpoint inhibitors.
The Group will make every effort to promote the clinical development of NBL-020 and strive to launch the product as soon as possible.
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