Nuvation Bio Says FDA Clears IND Application For NUV-868 To Treat Advanced Solid Tumors

Biopharmaceutical company Nuvation Bio Inc. (NUVB) announced Thursday that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-868 for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, metastatic castration resistant prostate cancer (mCRPC), and triple negative breast cancer (TNBC).

NUV-868 is a BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor. It inhibits BRD4, which is a key member of the BET family that epigenetically regulates proteins that control tumor growth and differentiation.

With the clearance of this IND for NUV-868 in advanced solid tumors, Nuvation Bio will be initiating a Phase 1/2 study of NUV-868 as a monotherapy and in combination with olaparib or enzalutamide in multiple tumor types.

This is the company's fourth IND in the last 14 months across its deep pipeline of innovative cancer therapeutics targeting multiple tumor types.

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