How Nuvation Bio Manages its Ongoing Clinical Trials

Pharmaceutical Executive recently spoke with Nuvation Bio’s president, CEO, and founder David Hung. The growing biotech is focused on oncology treatments is building a strong reputation in the space following a string of regulatory wins.

In June of 2025, Nuvation announced FDA’s approval of Ibtrozi, a next-generation oral ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). More recently, the biotech announced that UK’s drug regulatory body accepted the marketing application for taletrectinib.¹

During his conversation with Pharmaceutical Executive, Hung discussed the company’s relationship with the market, it’s current pipeline and upcoming goals, along with his approach to leadership and building a team that’s able to produce strong results.

Pharmaceutical Executive: Nuvation has multiple clinical trials running, can you discuss the status of these trials?
David Hung: We're approved for every line right now in ROS1 lung cancer, but we're trying to move the drug upstream, so that's why we're doing the adjuvant study for Ibtrozi.

Safusidenib is in pivotal studies, and we're trying to target both high- and low-grade glioma, so we have two studies already ongoing, and a third study that we're about to start to try to target all four pieces of the glioma opportunity.

They're both high- and low-grade gliomas, but those are further subdivided into high and low risk. We've shown activity that's very promising in all four of those types of glioma, both high- and low-grade, and both high and low risk. We're trying to develop this drug as thoroughly as possible for all the patients that could potentially benefit from this drug.

We're also developing a new platform of drugs, which we call our Drug-Drug Conjugate (DDC) program. This is very novel. I've talked a little bit about ADCs, where an antibody is used to target a small molecule warhead to a target to try to improve efficacy and also reduce toxicity, because it's a little bit more specific.

The problem with ADCs is that they're very large and they can't always go where they need to go. In fact, sometimes they even have a hard time even crossing the cell membrane. This is why some of the ADCs, in order to work, must release their warhead when it's no longer targeted. That can cause additional toxicity.

We've managed to develop a platform that has figured out a way to conjugate two small molecules to each other, and these two small molecules that we call drug-drug conjugates can target a specific cell target or a mechanism as a warhead (or two warheads or two targets, we can mix and match these molecules any way we want).

Our first program is going to be announced later this year, and we're pretty excited about that technology.

Source

1. Can Nuvation Bio Inc (NUVB) Stock Soar 150% From Current Level. Yahoo Finance. July 13, 2026. https://finance.yahoo.com/markets/stocks/articles/nuvation-bio-inc-nuvb-stock-092851856.html