Where does ZioPharma's "Sleeping Beauty" technology stand after the most recent Clinical Hold on the company's "very-rapidly manufactured CD19-specific T cells"?Ticker(s): ZIOP
A leader in the CAR-T space with familiarity on the technological developments as well as unmet need. Experience in the process of bringing CAR-T products to approval through clinical trials would be ideal.
Please describe your experience working in the CAR-T space.Added By: joe_mccann
Can you comment at a high level on your views of the "Sleeping Beauty" technology? How have those views evolved over time (If they have)?
Can you walk me through the "Safety Switch" for the program that received the clinical hold on 6/18/18?
- Am I correct in understanding it is referenced in this poster: Link
According to management, the FDA's decision to place a clinical hold on Ziopharm's Phase I trial was primarily related to the CMC section of the application. While no specifics were given on our call, we do know that additional preclinical studies surrounding the treatment and the ability to manufacture these mIL15 CD19-specific CAR-T cells in <2 days were required.
- Does this sound plausible to you for this stage of development?
- Do you think the "Safety Switch" itself might also play a role in the FDA's decision?
Can you summarize your thoughts on your excitement for this technology on a scale of 1-10 please?Added By: joe_mccann
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