Celyad (NASDAQ:CYAD) announces that the FDA has signed off on its IND for its next-generation CAR-T candidate CYAD-02 clearing the way for clinical trials in relapsed/refractory acute myeloid leukemia (AML). Enrollment in a Phase 1 dose-escalation study should commence in early 2020. The company says CYAD-02 is based on licensor Horizon Discovery’s optimized shRNA SMARTvector technology.
In a Phase 1 trial, first-generation CYAD-01 showed “preliminary anti-leukemic activity” in 46% (n=6/13) of AML patients. Preliminary data from cohort 4 should be available by year-end.
Management will host a conference call tomorrow, July 2, at 8:00 am ET to discuss its plans.
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