UPDATED: Ziopharm lays off half its staff after manufacturing issues force delays
New Ziopharm CEO Kevin Boyle has only been at the biotech for less than a month, but he’s already engineering major changes.
Late Monday afternoon, Ziopharm announced a sweeping restructuring that involved eliminating more than half its workforce and 60 jobs in total. The layoffs were necessary to help the penny stock player refocus its attention on advancing its TCR program, which saw a setback earlier this year after “unforeseen delays” at a contract manufacturer, Ziopharm said.
“We appreciate the many contributions the impacted employees made to Ziopharm and we commit to supporting these valued colleagues during this transition,” Boyle said in a statement.
In a follow-up email early Wednesday morning to Endpoints News, Boyle said the manufacturing site in question did not allocate the proper resources to Ziopharm’s projects.
“Deadlines continue to come and go without any work being advanced on our behalf,” Boyle wrote to Endpoints. “We’ve been told the robust job market has caused frequent poaching of their employees and caused the clock to reset on working to manufacture our product. We are now going to be in control of our own destiny and continue to invest developing internal manufacturing capabilities.”
Ziopharm’s TCR-T Library program is now expected to dose its first patient in a Phase I/II trial in the first half of 2022, pushed back from the second half of this year, the company added. The biotech blamed the delays on inadequate resources at the manufacturer.
It’s been a tough 12 months for the Boston-based biotech, having suffered an activist attack last November and seeing longtime CEO Laurence Cooper leave a few months after the dust settled in February. After a six-month search, Ziopharm’s board settled on Boyle as his successor. Boyle came over after a stint at Kuur Therapeutics, which was bought out for $185 million in May.
The activist attack spanned several weeks last fall following years of board turnover, with Ziopharm fighting with WaterMill Asset Management Corp. in uglier and uglier press releases. The pair even spent the Thanksgiving weekend last year attempting to refute one another and tout competing interpretations of an ISS report about the future of the company.
Ultimately, WaterMill was successful in the attack, convincing enough shareholders to elect two of its nominated candidates to the Ziopharm board in December 2020. WaterMill CEO Robert Postma was nominated at the time and did not receive enough votes, but has since joined the board as well.
Cooper’s departure came the following February at the same time Ziopharm announced the “fantastic news” of an IND clearance for their TCR T cell therapy program, the same library that’s now seeing manufacturing delays. Researchers are aiming to utilize six “hotspot” TCRs from its library, a “controlled IL-12” approach and a third-generation CD19 CAR-T.
Ziopharm has a checkered history in drug development, as its stock price $ZIOP has not recovered since a patient died in a study of its IL-12 gene therapy in 2016, though it was later deemed unrelated to the treatment. Two years later, Ziopharm was forced to halt a Phase I CAR-T study after the FDA placed a clinical hold and sought more information on chemistry, manufacturing and controls.
But earlier this year, Ziopharm saw some early, positive overall survival data for their controlled IL-12 treatment in glioblastoma. Nonetheless, shares are down more than 65% after Ziopharm hit a yearly high in early February.
This article was updated on Sept. 29, 2021 to include comment from Ziopharm CEO Kevin Boyle.