After swinging the ax on staffers last year and gaining a new CEO a few months back, Five Prime Therapeutics’ clinical development lead is hoping for a more stable time at new employer Spectrum Pharmaceuticals.
Lyndah Dreiling, M.D., becomes the biotech’s new senior vice president of clinical development, swapping the almost identical role she had at Five Prime.
Dreiling, who also had stints at Gilead Sciences and Amgen, will now help the company with its clinical work as it preps for a potential approval of Rolontis (eflapegrastim), which has a PDUFA date in October for patients with chemotherapy-induced neutropenia.
It’s also working on another cancer drug, EGFR inhibitor poziotinib, although this has not had the smoothest path. Late last year, Spectrum revealed data showing its med failed to meet its primary endpoint in the first cohort of participants in a midstage trial testing the drug in non-small cell lung cancer (NSCLC) harboring EGFR exon 20 mutations.
This saw its shares pretty much halved at the end of 2019, and they have not recovered so far in 2020.
In its financials posted a month ago, Spectrum said it was rejigging its so-called ZENITH20 trial evaluating poziotinib in NSCLC patients with EGFR and HER2 exon 20 insertion mutations.
“The protocol has been amended to explore additional dosing regimens and the earlier use of corticosteroids in an effort to increase drug compliance,” it said.
The second cohort of this test enrolling previously treated HER2 NSCLC patients “is fully accrued” with data expected in “mid-2020,” so, soon, if it maintains that timeline.
Cohort 3, meanwhile, which is enrolling first-line EGFR NSCLC patients, is “fully enrolled,” the biotech said, and is expected to have top-line results in the second half of 2020. It believes “either cohort has the potential to support a future NDA submission.” There are seven cohorts all told for this test.
Last year, the biotech got rid of its older marketed meds to focus on both Rolontis and poziotinib, moving into a more pure play biotech and leaving it exposed to the ups and downs of these meds.
Clearly, the company hopes Dreiling can help with its new focus. “We are excited to welcome Dr. Lyndah Dreiling, a proven world-class leader with broad expertise in drug development and a track record of success,” said Francois Lebel, M.D., chief medical officer at Spectrum Pharmaceuticals.
“Her depth of experience in hematology and oncology drug development from preclinical to Phase 1-4 studies will be highly valuable as we approach our PDUFA date for Rolontis, continue to execute our updated poziotinib development strategy, and further advance our emerging pipeline.”