After taking a look at phase 1 data, Nuvation Bio has decided to halt work on its one-time lead BD2-selective BET inhibitor while considering the program’s future.
The company has come to the decision after a “careful review” of data from phase 1 studies of the candidate, dubbed NUV-868, to treat solid tumors as both a monotherapy and in combination with AstraZeneca-Merck's Lynparza and Pfizer-Astellas' Xtandi.
Specifically, the Lynparza combo had been assessed in a phase 1b trial in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors. The Xtandi portion of that trial only assessed individuals with mCRPC.
Nuvation’s number one priority right now is taking its ROS1 inhibitor taletrectinib to the FDA with the ambition of a rollout to U.S. patients next year.
“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,” CEO David Hung, M.D., explained in the biotech’s second-quarter earnings release this morning.
Nuvation is “evaluating 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 outcomes for patients.”
NUV-868 rose to the top of Nuvation’s pipeline two years ago after the FDA placed a partial hold on the company’s CDK2/4/6 inhibitor NUV-422 over unexplained cases of eye inflammation. The biotech decided to end the NUV-422 program, lay off over a third of its staff and channel its remaining resources into NUV-868 as well as identifying a lead clinical candidate from its novel small-molecule drug-drug conjugate platform.
Since then, taletrectinib has crept up the priority list, with the company now eyeing the opportunity to bring the ROS1 inhibitor to patients as soon as next year. The latest pooled date from the phase 2 TRUST-I and TRUST-II studies in non-small cell lung cancer are set to be presented at the European Society for Medical Oncology Congress in September, with Nuvation using this data to support a planned approval application to the FDA.
Nuvation ended the second quarter with $577.2 million in cash and equivalents, having completed its acquisition of fellow cancer-focused biotech AnHeart Therapeutics in April.