FDA clears Nuvation Bio's IND Application For NUV-868 In Advanced Solid Tumors

The FDA has signed off Nuvation Bio Inc's NUVB investigational new drug (IND) application to evaluate NUV-868 to treat advanced solid tumors.

• NUV-868 inhibits BRD4, a key member of the BET family that epigenetically regulates proteins that control tumor growth and differentiation. 
• NUV-868 is designed to be more selective for BD2 than BD1 in an attempt to avoid the therapeutic limiting toxicities of other BRD4 inhibitors like gastrointestinal (GI) and bone marrow toxicities.
• 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 protocol (NUV-868-01) will begin with a Phase 1 monotherapy dose-escalation study in advanced solid tumor patients. 
• A Phase 1b study will then be initiated exploring NUV-868 plus olaparib in previously treated ovarian cancer, pancreatic cancer, mCRPC, and TNBC patients and combined with enzalutamide for mCRPC patients.
• A Phase 2b study will further explore safety and efficacy once the recommended Phase 2 combination dose is determined. 
• A Phase 2 monotherapy study will also be initiated in mCRPC patients to explore safety and efficacy further.
• As of December 31, 2021, the Company held cash, cash equivalents, and marketable securities of approximately $765 million.
• Price Action: NUVB shares are up 6.54% at $5.70 during the premarket session on the last check Thursday.