On December 21, 2022 NovaRock Biotherapeutics Limited announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for NBL-020, a tumor necrosis factor receptor 2 (TNFR2) antibody for the treatment of advanced solid tumors (Press release, NovaRock Biotherapeutics, DEC 21, 2022, View Source [SID1234625494]). The Phase I clinical trials will evaluate safety, tolerability and pharmacokinetics of NBL-020.

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About NBL-020

TNFR2 belongs to the TNF receptor (TNFR) superfamily and promotes tumor progression directly or indirectly by maintaining an immune-suppressed microenvironment for tumor cells via various signaling pathways. It stimulates various immune suppressive cell types, including regulatory T-cells (Tregs) and myeloid-derived suppressor cells (MDSCs) and can act as an oncogene. Inhibition of highly suppressive Tregs and MDSCs using TNFR2 antibodies in TME is a promising novel strategy for the treatment of advanced solid tumors.

NBL-020 is a fully human antibody against TNFR2 discovered and developed from NovaRock’s proprietary AFIS platform. Preclinical studies have demonstrated that NBL-020 has an excellent safety profile, high affinity to target cells and potent anti-tumor activity. NBL-020 inhibits tumor growth and prolongs survival as a single agent or in combination with anti-PD1 antibodies in both PD-1 sensitive and PD-1 resistant syngeneic models. Although PD-1/PD-L1 inhibitors have made remarkable breakthroughs in solid tumor treatment. There are still significant unmet medical needs for PD-1/PD-L1 resistant/refractory tumors. NBL-020 offers potential advantages to treat anti-PD-1/PDL1 resistant and PD-1 refractory patients.

NovaRock also filed an IND application to National Medical Products Administration (NMPA) in PRC in November 2022.