David Hung's Nuvation Bio axes clinical program, lays off 30 after researchers say they can't manage the side effects
The latest biotech to sound the alarm comes from a David Hung startup, and it comes a little over a month after receiving a series of FDA holds.
Nuvation Bio announced Monday it would discontinue development on one of its early-stage clinical programs after regulators halted a handful of studies in late June. On top of this, Nuvation plans to lay off 30 employees, representing about 35% of its workforce, according to an SEC filing.
Investors reacted a bit negatively, as the company’s shares $NUVB fell about 5% in early Monday trading.
The experimental drug on the chopping block is known as NUV-422, a CDK inhibitor program for certain types of solid tumors. In June, the FDA found some patients in one of the studies came down with uveitis, a type of inflammation in the eye. Regulators imposed a partial hold on a Phase I/II monotherapy study and full holds on two combo Phase Ib/II studies, Nuvation Bio said.
Researchers were instructed to implement a mitigation plan to prevent such inflammation from happening in the future. But Nuvation claims there simply aren’t enough data to know whether the inflammation was caused by the drug candidate, and has instead ended the program’s development altogether.
“Following an extensive analysis of the Phase 1 dose escalation study of NUV-422 in solid tumors, we made the determination that uveitis cannot be safely managed,” Hung, Nuvation Bio’s CEO, said in a prepared statement.
Going forward, Nuvation will focus its efforts on its BD2-selective BET inhibitor, dubbed NUV-868. The drug is currently in a Phase I dose escalation study in advanced solid tumors, with Nuvation dosing its first patient earlier this year. NUV-868 is also being researched in combination with other drugs to treat ovarian, breast, pancreatic and prostate cancer.
Nuvation Bio is just the latest biotech to suffer from the bruising bear market as dozens of companies have engaged in layoffs and pipeline reorganizations. Nuvation, though, may be in a bit of a stronger cash position than most, as it will retain more than $700 million in cash, cash equivalents and marketable securities as of June 30.
The company also says the savings associated with Monday’s news will still leave the company enough runway through 2028.
