NovaRock Biotherapeutics Announces FDA Approval of IND Application for NBL-020
Ewing, NJ, 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. The Phase I clinical trials will evaluate safety, tolerability and pharmacokinetics of 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.
About NovaRock Biotherapeutics Limited
NovaRock Biotherapeutics is an innovative and dynamic biotech company based in the U.S. and is dedicated to the development of novel antibody therapies for cancer and autoimmune diseases. It has a rich pipeline of novel monoclonal and multi-specific antibody molecules at various development stages from early discovery, preclinical to clinical studies. NBL-020 is the third molecule developed by NovaRock Biotherapeutics that is entering into clinical trials.