Two and a half years after setting out on another foray into oncology R&D, a biotech headed by David Hung – of Medivation fame – has run into its first setback.
San Francisco-based Nuvation Bio announced early Monday the FDA placed a partial clinical hold on a Phase I dose-escalation study of NUV-422, its CDK inhibitor program for certain types of solid tumors. The trial began enrolling patients in December 2020, and, according to Nuvation, researchers were in the middle of exploring dose escalation and defining the maximum dose tolerable in patients.
The indications being investigated include high-grade glioma, HR+/HER2- advanced breast cancer and metastatic castration-resistant prostate cancer.
Nuvation came out of stealth in 2019 after being founded by the former head at Medivation, which was snapped up by Pfizer in 2016 for $ 14.3 billion in an all-cash deal. Medivation is largely known for in-licensing and developing the blockbuster prostate cancer drug Xtandi, racking up more than $ 1.1 billion last year for Pfizer.
When Nuvation officially came out of stealth, Hung had $ 275 million in VC backing and claimed to have seven programs in its pipeline. Hung founded Nuvation Bio after his 10-month stint as CEO at Vivek Ramaswamy’s Axovant, which tried and failed to take an Alzheimer’s drug into a pivotal study and infamously reported an incorrect p-value back in 2018.
Regarding the Nuvation hold, some patients in the study came down with uveitis, a type of inflammation in the eye, and Nuvation said it paused enrollment in the trial and reached out to the FDA. The company did not give specifics on the severity of uveitis in those patients, nor did it say how many patients got uveitis.
With the partial hold in place, no new patients will be enrolled. However, currently, enrolled participants can continue treatment with NUV-442.
“We are committed to patient safety across all of our studies and to working collaboratively with the FDA to develop, as efficiently as possible, new medicines where existing therapies are inadequate,” Hung said in a statement. The president and CEO added that the biotech is “well positioned to continue developing all of our internal product candidates.”
Even though Hung touted the company’s near- $ 740 million in cash reserve, investors weren’t appeased by his attempts to assuage the situation. The biotech’s share price $ NUVB sank about 6% in early Monday trading.
Nuvation declined to comment further on the story following an Endpoints News inquiry.
The biotech said in a press release that it will provide updates on what direction the company will take on NUV-422 after it has completed an internal risk-benefit analysis. While Nuvation said that analysis will factor in FDA’s comments, it did not say when that analysis is expected to be completed.