Small-Cap Cancer-Focused Nuvation Bio Pulls Plug On Early-Stage Program After Considering Phase 1 Solid Tumor Data

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 & Co Inc’s MRK 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 ALPMF 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 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.

Two years back, Nuvation Bio 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 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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