Bringing Autologous Natural Killer Cell Therapy to Parkinson Disease
Paul Y. Song, MD, the chairman and chief executive officer of NKGen, discussed discussed the new clinical study design for evaluating cell therapy SNK01 in PD.
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.
Paul Y. Song, MD
Credit: NKGen
NKGen Biotech's SNK01 is an investigational autologous natural killer (NK) cell therapy that the company originally developed for oncology indications. Although NKGen continues to evaluate the therapy in clinical trials for cancer, it has also begun to investigate its use in neurodegenerative diseases like Alzheimer disease (AD) and Parkinson disease (PD). A clinical trial in AD is already in progress, and following compassionate use studies in PD, the FDA cleared an investigational new drug (IND) application for SNK01 in PD in April of this year.1,2
Shortly after the IND clearance, CGTLive® reached out to Paul Y. Song, MD, the chairman and chief executive officer of NKGen. In an interview, he spoke about the clinical trial plans for SNK01 in PD and about positive results from a compassionate use study in a patient who has both PD and AD and who is also a personal friend of Song.
CGTLive: Can you tell us about the clinical trial plans for SNK01 in PD?
Paul Y. Song, MD: The first step is to enroll about 9 to 10 patients in the phase 1. We're using a cryopreserved NK cell product that is delivered every 3 weeks. We'll do all of the necessary assessments and once we show that it's safe we'll then move forward to a randomized phase 2 trial where we will give placebo versus our treatment. The dosing will be for a full year and we really do expect to see real dramatic improvements between the 2 groups.
The other thing that we should point out is that we've now dosed almost 100 patients I would say between all of our cancer trials, our AD trials, and our compassionate use trials, and we've not seen any side effect related to our treatment at all. There is no pretreatment unlike a lot of cell therapies where you have to give some lymphodepletion or some type of low dose chemotherapy or even some cytokine support—we do not have to do any pretreatment because it's your own NK cells that are not genetically modified. As such, it's a very simple outpatient infusion, in and out. We find our patients thus far have been really, really tolerating it extremely well with no side effects.
Is there anything else you would like to share with our audience?
One thing that is emerging I would say for PD is that the longer patients endure the disease, many of them also start to develop some cognitive changes. We actually are treating 1 patient—the FDA granted us compassionate use approval for somebody who has had PD for many years, but now has developed what the doctors consider early stage AD. So we're actually trying this in a patient that has both diseases. I think that we're very excited that we can affect both these diseases in the same patient. I think the potential for use in PD for any of your readers or clinicians that might read this who have patients that have the traditional tremors and things, but also are developing cognitive changes—this could actually prove to be something that could treat all of that.
The person that I mentioned, 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.
Transcript edited for clarity.
REFERENCES
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 August 5, 2024. https://nkgenbiotech.com/nkgen-biotech-announces-fda-clearance-of-investigational-new-drug-ind-application-for-snk01-nk-cell-therapy-in-parkinsons-disease/
2. NKGen Biotech’s SNK01 NK Cell Therapy Cleared to Start Phase 2 Clinical Trial in Alzheimer’s Disease. News release. NKGen Biotech. May 20, 2024. Accessed August 5, 2024. https://www.globenewswire.com/news-release/2024/05/20/2884834/0/en/NKGen-Biotech-s-SNK01-NK-Cell-Therapy-Cleared-to-Start-Phase-2-Clinical-Trial-in-Alzheimer-s-Disease.html
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