Hit by clinical holds for mystery eye inflammation, Nuvation drops tumor asset and reduces staff by a third

After receiving a flurry of clinical hold letters in relation to unexplained cases of eye inflammation, Nuvation Bio has resorted to drastic action to try to stay afloat. The biotech will not only discontinue development of the tumor drug in question but will lay off more than a third of its workforce in a bid to keep the money flowing for another five years.

In June, the FDA verbally placed a partial hold on a dose-escalation portion of a phase 1 study of the therapy, called NUV-422, in a range of different cancers. Nuvation also received letters from the agency putting a monotherapy phase 1/2 study on hold as well as for its combination phase 1b/2 studies of the drug.

The biotech made the decision to discontinue development of NUV-422 after considering feedback received from one of these letters, Nuvation said in a statement Monday morning. At the time of receiving the verbal hold instruction in June, Nuvation said it had proactively paused enrollment of new patients following the emergence of a safety signal, a type of eye inflammation called uveitis.

The FDA requested a mitigation plan to address this adverse event, but the company did not understand the link between uveitis and NUV-422 and was therefore unable to predict when it would occur again. Nuvation therefore believed “it would be difficult to craft an effective mitigation plan without significant further research.”

The company will now “intensify its focus” and concentrate resources on developing its BD2-selective BET inhibitor NUV-868 as well as identifying a lead clinical candidate from its novel small-molecule drug-drug conjugate platform. Patients are currently being enrolled in a phase 1 study of NUV-868, and Nuvation has plans for phase 1b studies of the therapy in combination with AstraZeneca-Merck's Lynparza or Pfizer-Astellas' Xtandi.

With $703.8 million in cash and securities as of the end of June, slimming down Nuvation’s pipeline will not be enough to extend the company’s cash runway through to 2028. As a result, the biotech is also planning to reduce its workforce by 35%.

“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,” said Nuvation CEO David Hung, M.D. “We sincerely thank all patients and investigators who were part of the NUV-422 clinical program for their prodigious efforts. We also thank our employees for their commitment to the Nuvation Bio mission. It was a difficult decision to discontinue the program and we are extremely grateful for each of their contributions.”

Nuvation declined to provide Fierce Biotech with details on how many staff will be affected by the layoffs or when they are likely to take place.

It’s not the first time the company has been forced to narrow its focus. The biotech deprioritized its Wee1 inhibitor NUV-569 and an adenosine A2A receptor antagonist in May so it could focus on NUV-868 and the now also dropped NUV-422.

To read more about layoffs across the biotech industry, check out Fierce Biotech's Layoff Tracker.