In its second-quarter earnings release, Nuvation Bio Inc ( NUVB ). announced that it has decided to halt work on NUV-868, its BD2-selective BET inhibitor, while considering the program’s future.

The company said it concluded the Phase 1b dose escalation study of NUV-868 in combination with AstraZeneca Plc ( AZN ) -Merck ( MRK ) & Co Inc’s Lynparza (olaparib) for ovarian, pancreatic, metastatic castration-resistant prostate (mCRPC), triple-negative breast cancer, and other solid tumors, and with Pfizer Inc ( PFE ) -Astellas Pharma Inc’s (OTC:ALPMF) (OTC:ALPMY) Xtandi (enzalutamide) for mCRPC.

The company completed an internal analysis of efficacy and safety data from Phase 1 monotherapy and Phase 1b combination studies of NUV-868.

Following this analysis, Nuvation Bio ( NUVB ) decided not to initiate a Phase 2 study of NUV-868 as a monotherapy or combined with olaparib or enzalutamide in the advanced solid tumor indications that were part of the Phase 1 and Phase 1b study designs.

The company is evaluating the next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve patient outcomes.

“As we focus on our late-stage pipeline and prepare to potentially bring taletrectinib to patients in the U.S. in 2025, we have decided not to initiate a Phase 2 study of NUV-868 in the solid tumor indications studied to date. This decision comes after a careful review of the data generated in the Phase 1 monotherapy study and Phase 1b study of NUV-868 in combination with olaparib or enzalutamide. We are exploring next steps for NUV-868 in new indications and will share updates as available,” said David Hung, Founder, President, and CEO of Nuvation Bio ( NUVB ).

Two years back, Nuvation Bio ( NUVB ) discontinued the clinical development of NUV-422 after an internal risk-benefit analysis factoring in feedback from the FDA in a partial clinical hold letter for monotherapy Phase 1/2 study and clinical hold letters for its combination Phase 1b/2 studies.

As of June 30, 2024, Nuvation Bio ( NUVB ) had cash, cash equivalents, and marketable securities of $577.2 million.

Price Action: NUVB stock is down 7.41% at $3.11 at last check Monday.

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