CAR-T filing in sight, Frank Zhang grabs full control of J&J-partnered Legend Biotech, steps down from GenScript

Two months after Yuan Xu steered Legend Biotech to a $424 million public debut on the Nasdaq, founder and chairman Frank Zhang is grabbing the reins as CEO.

In conjunction with the move, Zhang is also stepping down from the helm of GenScript — a position he’s held for 18 years. GenScript, a Hong Kong-listed CRO, hatched Legend as a subsidiary in 2015 before spinning it out, and remains a majority shareholder.

“This shows how much commitment I have for Legend,” he said in a conference call. “Over the past years, Legend has always been under my watch. And I’m very interested in seeing how it will grow in the next few years.”

Now is the natural time for a transition as Legend and its partners at J&J gear up to initiate a BLA filing of their BCMA-targeted CAR-T therapy by the end of the year, with an EMA filing to follow in early 2021.

“I can assure you that this CEO transition has nothing to do with any change in the planned activities for the JNJ-4528 program, including clinical development and also regulatory plans,” CFO Ying Huang said in the call.

Having built up a resume featuring a who’s who in Big Pharma — spanning Genentech, GlaxoSmithKline, Novartis, Amgen, Gilead and Merck — Xu took the helm in 2018 and has been running Legend out of New York. She stepped down for “personal reasons,” according to a press release.

Zhang promised that the daily operations and relationship with J&J should remain intact.

Jefferies analyst Biren Amin was convinced. While the EMA timeline marks a slight delay from the original plan, he’s not bothered either.

“We think Legend purposely takes extra time to prepare a strong CMC package, to stay on the safe side,” he said.

The company might have taken a page from rivals’ recent troubles, he added:

Recall that BMS and BLUE received Refusal-To-File (RTF) letter by FDA for the BLA submission of ide-cel/bb2121 in Mar ’20 and resubmitted at the end of July, which caused a 4-mos delay in regulatory path. FDA required a supplemental documentation of CMC to provide details on validation control process, and we think Legend takes actions to minimize any potential regulatory risks.