Paul Y. Song, MD, on Bringing SNK01 to Clinical Trials for Parkinson Disease

This is the third part of an interview with Paul Y. Song, MD. For the first part, click here. For the second part, click here.

“[With regard to] my friend who we’ve been treating on compassionate use... Every afternoon around 3 or 4 o'clock he starts to develop brain fog—and this is where after our treatment, he notices that he has mental clarity throughout the rest of the day. So again, this is an area that we are very actively looking at—in addition to monitoring the traditional PD symptoms, we also are going to look for improvement in cognitive function in our patients as well.”

NKGen Biotech’s SNK01 is a natural killer (NK) cell therapy comprised of autologous NK cells that are not genetically engineered, but have enhanced cytotoxicity and activating receptor expression. It is currently in clinical development for a variety of indications, including solid tumor cancers and Alzheimer disease (PD). Most recently, in April 2024, the company received clearance of an investigational new drug application for a trial to evaluate SNK01 in Parkinson disease. Following up on this news, CGTLive® reached out to Paul Y. Song, MD, the chairman and chief executive officer of NKGen, to learn more about future plans for the NK cell therapy.

In a May 2024 interview, Song described the plans for the phase 1/2a clinical trial, which will treat patients with SNK01 in doses delivered every 3 weeks. After safety is confirmed in 9 to 10 patients in the phase 1 portion, the phase 2a portion will take the form of a randomized, placebo-controlled study with dosing taking place for a 1 year timeframe. In addition to describing the trial plans, Song noted that SNK01 does not require lymphodepleting chemotherapy, which may account for the promising safety track record it has shown so far: across almost 100 patients who have received the NK cell therapy in the cancer and AD trials or in compassionate use contexts, there have been no adverse events deemed related to SNK01.

Song also discussed how PD has been associated with cognitive decline in patients who have had the disease for a long time. He spoke about the case of his personal friend, who has received SNK01 in a compassionate use study, and has since experienced cognitive improvements.

REFERENCE
1. NKGen Biotech announces FDA clearance of investigational new drug (IND) application for SNK01 NK cell therapy in Parkinson’s disease. News release. NKGen Biotech, Inc. April 30, 2024. Accessed July 12, 2024. https://nkgenbiotech.com/nkgen-biotech-announces-fda-clearance-of-investigational-new-drug-ind-application-for-snk01-nk-cell-therapy-in-parkinsons-disease/