Nuvation Bio to discontinue development of NUV-1511

In a regulatory filing, Nuvation Bio (NUVB) announced its decision to discontinue development of NUV-1511, the first compound in its first-of-its-kind drug-drug conjugate program. While NUV-1511 was well tolerated and did demonstrate promising signals in some patients, the company said it has made this decision due to lack of sufficiently consistent efficacy across cohorts. The company is not terminating the DDC platform. Instead, the company will be using information learned from the NUV-1511 program to evaluate new DDC candidates that may have more consistently robust activity. Resources budgeted for NUV-1511, which included a projected $100-150 million in R&D and CMC-related costs through 2029, will be transferred to other pipeline molecules and to the development of next-generation DDC candidates, incorporating key learnings from NUV-1511. The company recently announced first patient in part 2 of G203, a global randomized study of safusidenib, a novel, selective, potent, oral mIDH1 inhibitor, in high-risk grade 3 or grade 4 IDH1-mutant glioma. The company will also continue to invest in the commercial launch of IBTROZI and development of the program, including enrollment of the TRUST-IV study evaluating the medicine in the adjuvant setting of early-stage ROS1+ NSCLC.