By Chris Wack


Nuvation Bio Inc. said the U.S. Food and Drug Administration has cleared its investigational new drug application to evaluate NUV-868, a BD2-selective oral small molecule bromodomain and extra-terminal inhibitor.

The company said NUV-868 is used for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, metastatic castration resistant prostate cancer and triple negative breast cancer.

Nuvation Bio said it is looking to advance the program into Phase 1 development in mid-2022.

With the clearance of this IND for NUV-868 in advanced solid tumors, Nuvation Bio would be initiating a Phase 1/2 study of NUV-868 as a monotherapy and in combination with olaparib or enzalutamide in multiple tumor types. A Phase 2 monotherapy study would also be initiated in mCRPC patients as well to further explore safety and efficacy.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

01-20-22 0727ET