China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving Investigational New Drug (IND) approval from the US FDA for its antibody-drug NBL-020. The targeted indication is advanced solid tumors, marking a significant step forward in the development of this innovative therapy.
Drug Profile and Mechanism of Action
NBL-020 is an anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody (mAb) based on CSPC’s proprietary AFIS technology platform. TNFR2, a member of the tumor necrosis factor receptor (TNFR) superfamily, maintains the microenvironment of tumor cell immunosuppression through various signal pathways and directly or indirectly promotes tumor progression. It stimulates various immunosuppressive cell types, including regulatory T cells (Tregs) and bone marrow-derived suppressor cells (MDSCs), and can be used as an oncogene.
Preclinical Data and Future Prospects
Pre-clinical studies have shown that NBL-020 exhibits good safety, high affinity to target cells, and strong anti-tumor activity. In PD-1 sensitive and PD-1 resistant syngeneic animal models, NBL-020 as a monotherapy or combined with an anti-PD-1 antibody can inhibit tumor growth and prolong survival. This promising data positions NBL-020 as a potential new treatment option for patients with advanced solid tumors.
Global Landscape and Competitive Environment
BioInvent’s BI-1808, the world’s first TNFR2 inhibitor to receive clinical trial approval, is entering Phase IIa clinical study. In China, Leads Biolabs’s LBL-019 is under trial review. Additionally, Begene’s in-licensed TNFR2 antibody BITR2101 is expected to be used in combination with tislelizumab. Adlai Nortye and Sincere’s TNFR2 mAbs are at the pre-clinical stages. The IND approval for NBL-020 underscores CSPC’s commitment to advancing innovative oncology therapies and contributing to the global effort to combat cancer.-Fineline Info & Tech
