'Can't say no': Kite Pharma taps Frank Neumann as new head of clinical development
Kite Pharma hit a major landmark in July when it got a second FDA OK, creating the first commercial CAR-T portfolio. But a biotech’s work is never done. Now it’s time to expand — and the Gilead subsidiary has tapped a new global head of clinical development to lead the charge.
“Kite was always kind of on the horizon as the… dream job come true,” Frank Neumann told Endpoints News. “This is a position (where) if you’re interested in cell therapy, if you’re interested in making a big impact on patients’ lives, you just can’t say no.”
The Rheinische-Friedrich-Wilhelm University grad cut his teeth in cell therapy at Takeda, where he served as global head of clinical development for projects from proof-of-concept to Phase I evaluation. After that, he spent about two years at bluebird bio, then just two weeks as CMO of Verastem Oncology before jumping to Kite.
“The people at Verastem, the data, the science — brilliant,” he said. But if “someone offers you to fly to the moon, you’re going to become an astronaut,” he said of the decision to leave.
Neumann is taking over for Ken Takeshita, who is leaving the company at the end of this month to pursue another opportunity, Kite vaguely announced on Monday morning.
Takeshita is passing the torch just before the FDA is set to make a decision on Kite’s supplemental BLA for three-year-old Yescarta in follicular lymphoma (FL) and marginal zone lymphoma (MZL), two types of indolent non-Hodgkin’s lymphoma (iNHL). The company read out positive data from the Phase II ZUMA-5 trial at virtual ASH 2020 to back the new indication, and regulators have set a PDUFA date for March 5.
“Lymphoma — Yescarta, Tecartus — will remain a key focus,” Neumann said, while declining to go into much detail on what’s coming down the pipeline. He pegged solid tumors (which he called the “Holy Grail”) and additional hematological malignancies as long-term goals.
“The fundamental theme is, I think, bringing cell therapy to a point where we answer the question: Where can we use it?” he added later.
Gilead became an overnight CAR-T leader when it bought Kite for $12 billion back in 2017, snatching up Yescarta in the process. It nabbed a quick OK in relapsed or refractory large B-cell lymphoma two weeks later — not long after Novartis’ Kymriah became the world’s first approved CAR-T therapy. This past July, Kite nabbed its second approval with Tecartus for treatment for relapsed or refractory mantle cell lymphoma.
But Kymriah makes for tough competition. Back in August, Novartis said it got the interim results it was looking for from a Phase II Kymriah trial in follicular lymphoma, and announced plans to file with the FDA in 2021.
Looking to get a leg up in the CAR-T battle, Kite released more data to bolster Yescarta at ASH in December, including interim results from ZUMA-12, a Phase II study assessing Yescarta as a first-line treatment in large B-cell lymphoma. After a single infusion, 85% of patients achieved a response, including 74% who saw a complete response. And with a median follow-up of 9.3 months, 70% of response-evaluable patients had ongoing responses, according to Gilead.
The company also read out long-term results from its Zuma-1 trial in large B-cell lymphoma, in which patients had a median overall survival of more than two years.
Tecartus, on the other hand, is in various ongoing studies for adult acute lymphoblastic leukemia (ALL), pediatric ALL and NHL, and chronic lymphocytic leukemia.
A previous version incorrectly referred to the company as Kite Therapeutics. A correction has been made.