NEW YORK – NKGen Biotech this week said that the first patient has received its investigational post-stroke autologous cell therapy troculeucel within an expanded access program (EAP).
The US Food and Drug Administration allows patients with serious or life-threatening conditions to gain access to investigational products outside of clinical trials through EAPs, if other treatment options aren't available. Santa Ana, California-based NKGen said this single compassionate-use clearance from the FDA could be an initial step toward filing a full investigational new drug (IND) application and seeking permission to formally take troculeucel into clinical trials.
"We believe that troculeucel could potentially be a novel approach to reduce chronic neuroinflammation and the associated long-term sequelae in the post-stroke setting," NKGen CEO and Chairman Paul Song said in a statement.
NKGen is conducting the EAP with Dimitri Sigounas, an associate professor of neurological surgery, and Amarendra Neppalli, director of transplant and cellular therapy, at George Washington University Hospital in Washington, DC. Within the program, the patient will receive infusions of troculeucel and undergo multiple assessments with Sigounas.
Troculeucel is an immunotherapeutic, in which a patient's autologous natural killer cells are expanded ex vivo. It is designed to reduce or prevent chronic neuroinflammation in patients who have suffered a stroke or traumatic brain injury. This chronic neuroinflammation can lead to subsequent neurological damage, NKGen said.
Separately, NKGen is evaluating troculeucel as a treatment for Alzheimer's disease within a Phase II trial. Investigators in that trial have observed improvements in biomarkers of brain injury in patients on troculeucel, such as changes in levels of neurofilament light chain and glial fibrillary acidic proteins. NKGen said it is also developing troculeucel as a treatment for additional neurodegenerative disorders and cancers.