Celularity’s CYNK-001 Receives the US FDA’s Fast Track Designation for the Treatment of AML
Shots:
- The US FDA has granted FTD for CYNK-001 to treat patients with AML
- The designation helps to expedite the development, review, and potential approval of treatments for serious diseases. The company has planned to continue dose escalation in the MRD indication & expand the study for patients with AML
- CYNK-001 is a non-genetically modified, cryopreserved allogeneic off-the-shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells which are currently in development for hematologic malignancies, solid tumors, and infectious diseases. Additionally, the therapy has received ODD for malignant gliomas and FTD for glioblastoma multiforme
Ref: Globe Newswire | Image: Celularity
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