NKGen Biotech Receives FDA IND Approval for SNK01 NK Cell Therapy in Parkinson’s Disease

May 06, 2024 16:19 CST Updated 16:19

NKGEN Biotech

Cellular Immunotherapy Drug Developer

Recently,NKGen Biotech, a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK/NK cell therapies, announced itsIND Application for SNK01, an NK Cell Therapy for Treating Parkinson’s Disease (PD), Approved by U.S. FDA。

SNK01 is a non-genetically modified autologous NK cell therapy that isolates and screens target NK cells from the patient’s blood after collection, then activates the NK cells and promotes their expansion.SNK01 exhibits enhanced cytotoxicity and activated receptor expression. Combined with NKGen Biotech, Inc.'s proprietary cryopreservation process, the cells can maintain significant viability and cytotoxicity, potentially becoming a new treatment method for Parkinson's disease.。

IND Approval Enables NKGen to Launch Phase 1/2a Clinical Trial for Parkinson's Patients, Evaluating the Safety, Tolerability, and Exploratory Efficacy of SNK01 in PD Patients.The trial aims to recruit up to 30 patients (20 receiving SNK01 treatment and 10 receiving placebo treatment).NKGen Biotech, Inc. is expected to begin trials in the second half of 2024, with the first patient receiving the drug treatment.

The approval of this IND marks an important milestone for NKGen Biotech in advancing its NK cell therapy pipeline for neurodegenerative diseases.Previously,SNK01 Was Used to Treat Alzheimer's Disease (AD) Patients and Showed Positive Data in Phase I TrialSNK01 appears to reduce blood biomarkers of Alzheimer's disease in trial patients:Aβ42/40 amyloid and reduce neuroinflammation (GFAP).Notably, despite a median baseline MMSE score of 14 and two-thirds of patients receiving a suboptimal dose of SNK01, 90% of patients showed improved or stable cognitive function at week 11 based on the ADCOMS assessment, suggesting that SNK01 may do more than just slow disease progression.

E.N.D

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