NKGen Receives FDA Approval For Expanded Access Use Of Troculeucel In Neurodegenerative Diseases

NKGen Biotech, Inc., a clinical-stage biotechnology company developing innovative natural killer (NK) cell therapies, announced that the U.S. FDA has approved an Expanded Access Program (EAP) IND protocol for troculeucel. This authorization will enable the use of troculeucel in treating a broader range of neurodegenerative diseases beyond those included in their current clinical trials.

“There is a common element of autoimmune neuroinflammation in all of these neurodegenerative diseases due to autoreactive T cells, many in response to either an amyloid, alpha-synuclein, or tau protein deposition. As we have demonstrated in two Phase I trials in Alzheimer’s Disease, troculeucel, given via a simple IV, appears to cross the blood brain barrier to reduce neuroinflammatory and protein biomarkers in CSF. We believe there is ample scientific and clinical rationale to offer this to patients with other neurodegenerative diseases for which there is no effective therapy and little hope. We will begin enrolling patients as soon as possible, but the speed of enrollment will depend on funding,” said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech.

While NKGen is currently conducting a randomized Phase 2a trial targeting moderate-stage Alzheimer’s disease (NCT06189963), the new EAP IND allows the company to provide access to troculeucel for patients suffering from earlier-stage Alzheimer’s and a variety of other neurodegenerative disorders. These include Parkinson’s Disease, ALS, MSA, PSP, FTD, CBD, MS, and Lewy Body Dementia, many of which currently lack effective treatments.

Under this program, NKGen will be able to treat up to 20 patients across multiple sites, potentially broadening its understanding of troculeucel’s safety and efficacy across various disease states. The move reflects NKGen’s commitment to advancing NK cell-based therapies for underserved patient populations.