Ziopharm Oncology’s executive vice president of R&D, Francois Lebel, M.D., is moving to cancer drugmaker Spectrum Pharmaceuticals to serve as its chief medical officer effective Nov. 5.
Lebel joins Spectrum ahead of planned product submissions to the FDA, including the filing of Rolontis (eflapegrastim) for treating low white blood cell counts following chemotherapy, which is expected before the end of the year.
Another priority is expanding development of the EGFR-, HER2- and HER4-inhibiting poziotinib into broader patient populations, while Spectrum seeks a breakthrough designation for the drug, according to Joe Turgeon, Spectrum’s president and CEO.
“In evaluating Spectrum's pipeline drugs, I have been very impressed with the robust clinical data, especially the recently released poziotinib data in heavily pretreated lung cancer patients who have very few options,” Lebel said in a statement, describing his plans to “aggressively expand” the use of the drug into other indications.
In September, Spectrum unveiled preliminary data from a phase 2 non-small cell lung cancer (NSCLC) study in collaboration with MD Anderson Cancer Center that showed anti-tumor activity in heavily pretreated metastatic patients. With a median progression-free survival of 5.5 months, 43% of patients demonstrated an objective response.
Spectrum is currently recruiting patients for a separate phase 2 open-label study in NSCLC patients with EGFR and HER2 exon 20 insertion mutations. Poziotinib is also being studied in HER2-positive metastatic breast cancer.
At Ziopharm, where he also served as CMO, Lebel was present for the slimming down of its R&D portfolio when it split its cancer programs with Intrexon’s Precigen unit earlier this month.
The overhauled oncology alliance left Ziopharm with two immunotherapy programs focused in controlled IL-12 and sleeping beauty-driven CAR-T and TCR-T therapies, which use a nonviral gene transfer system to modify T cells.
Those changes came after a year that saw Ziopharm’s CD19-targeting CAR-T receive a clinical hold, delaying phase 1 dosing and the company pausing a phase 3 trial of Ad-RTS-hIL-12 in recurrent glioblastoma multiforme due to issues in chemistry, manufacturing and controls.
Before Ziopharm, Lebel was VP of R&D at Baxter International, as well as global head of medical and scientific affairs at MedImmune, and has helped lead at least eight drug and biologic applications in various therapeutic areas.