pp-185 Solution for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
GMP approvals
PICS
Comments
Indication: Acute myeloid leukaemia (AML) with measurable residual disease (MRD+) after allogeneic haematopoietic stem cell transplantation (HSCT)
Clinical stage: Phase 2 — ongoing
Modality: Biological (allogeneic memory natural killer cell therapy — off-the-shelf)
Mechanism / Target: Ex vivo-expanded allogeneic memory NK cells; leverages NK cell memory-like properties for enhanced and sustained anti-leukaemia activity against MRD+ residual blasts post-transplant
Route / form: IV infusion
Differentiation: First allogeneic memory NK cell therapy in clinical development for AML MRD+; off-the-shelf manufacturing (no patient-specific product); addresses high-risk MRD+ relapse post-HSCT with no approved treatment
Manufacturer #39326
South Korean biotech founded in 2020 developing clinical-stage Rx NK cell-based anti-cancer immunotherapies for solid and hematologic tumors. Lead injectable biologic program holds FDA Orphan Drug designation for acute myeloid leukemia. Advances global development through clinical trials and international regulatory engagements.
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