FDA grants fast track designation to natural killer cell therapy for advanced AML
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The FDA granted fast track designation to CYNK-001 for the treatment of adults with relapsed or refractory acute myeloid leukemia.
CYNK-001 (Celularity) is a nongenetically modified allogeneic natural killer (NK) cell therapy. Researchers derived the cryopreserved agent from donor human placental hematopoietic stem cells and are developing it as a treatment for hematologic malignancies, solid tumors and infectious diseases.
The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases. The regulator previously granted the agent fast track designation for glioblastoma multiforme and orphan drug designation for the treatment of malignant gliomas.
“The majority of patients with AML continue to have poor long-term outcomes, particularly those who suffer relapse or have measurable residual disease, necessitating development of novel therapies, including CYNK-001,” Andrew Pecora, MD, president of Celularity, said in a company-issued press release.
CYNK-001 is currently being evaluated as part of a phase 1 dose-escalation study in adults with minimal residual disease (MRD)-positive primary or secondary AML in morphologic complete remission. Study patients will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single infusion of CYNK-001 at one of three dose levels.
Dose-limiting toxicity and frequency of treatment-related severe adverse events will serve as the study’s primary outcome measures. Secondary outcome measures will include MRD-negativity status and several other treatment efficacy outcomes
“We believe that the unique properties of our cell source, including the ability to proliferate and maintain activity, could be the key to improving response rates and durability for patients,” Robert Hariri, MD, PhD, founder, chairperson and CEO of Celularity, said in the statement. “We are pleased to receive this fast-track designation from the FDA for AML supporting continued development of our placental-derived NK cell platform.”
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