FDA Clears Nuvation Bio’s IND Application for NUV-868 in Advanced Solid Tumors


the FDA approved Nuvation Bio Inc NUVB investigational new drug (IND) application to evaluate NUV-868 in the treatment of advanced solid tumors.

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

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