NKGen’s autologous natural killer (NK) cell therapy SNK01 has received clearance of an investigational new drug (IND) application from the FDA for a phase 1/2a clinical trial in patients with Parkinson disease (PD).1
The planned trial will seek to enroll up to 30 patients, 20 of whom will be treated with SNK01, and 10 of whom will receive a placebo. NKGen anticipates that it will dose the first patient in the study in the second half of this year.
“The IND clearance marks a significant milestone as we advance our pipeline of NK cell therapy in neurodegenerative diseases,” Paul Y. Song, MD, the chairman and chief executive officer of NKGen, said in a statement.1 “This is our second IND approval for SNK01 within the past several months and underscores our focused dedication towards developing safe and effective treatments that target both protein deposition and neuroinflammation for patients with neurodegenerative diseases such as Alzheimer disease (AD) and PD. We are excited to start our first clinical trial in PD as there currently is a high unmet medical need in this indication.”
SNK01 is comprised of autologous NK cells that are not genetically engineered, but have enhanced cytotoxicity and activating receptor expression. The cell therapy was previously approved for a compassionate use administration to a patient with PD in February 2023.3 SNK01 is the subject of a collaboration between NKGen Biotech and the Parkinson’s Foundation minted in November 2022.2 The collaboration is focusing on ways to help accelerate the development of SNK01 for the treatment of advanced PD through its network of clinical partners and donors.
Key Takeaways
- NKGen’s autologous natural killer (NK) cell therapy SNK01 has received clearance of an investigational new drug (IND) application from the FDA for a phase 1/2a clinical trial in patients with Parkinson disease (PD).
- The planned trial will seek to enroll up to 30 patients, 20 of whom will be treated with SNK01, and 10 of whom will receive a placebo. NKGen anticipates that it will dose the first patient in the study in the second half of this year.
- SNK01 is comprised of autologous, NK cells that are not genetically engineered, but have enhanced cytotoxicity and activating receptor expression.
SNK01 is also being evaluated in the phase 1 ASK-AD clinical trial (NCT04678453) for the treatment of AD.4 Data from ASK-AD was presented at the Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting, held October 24 to 27, 2023, in Boston, Massachusetts. It was noted that among 10 patients evaluated compared to their baseline at 1 week after receiving their final dose in the trial, 30% of patients demonstrated clinical improvement on Alzheimer’s disease composite score (ADCOMS), 60% of patients demonstrated a stable ADCOMS score, and one patient who previously had an ADCOMS score classified as moderate achieved an ADCOMS score classified as mild. Furthermore, 50% to 70% of the 10 patients showed scores that were stable or improved compared to baseline on the Clinical Dementia Rating-Sum of Boxes, the Alzheimer’s Disease Assessment Scale-Cognitive Subscale, and the Mini-Mental State Examination.
“Given the encouraging outcomes regarding the reduction in neuroinflammation observed in our phase 1 AD trials, we are optimistic about the potential benefits that may emerge in our PD trial,” Song continued.1 “Although these two neurodegenerative diseases differ, both share a neuroinflammatory component, which has led to our hypothesis that SNK01 may be beneficial in both indications. While directly inhibiting neuroinflammation, whether as an independent approach or in conjunction with other interventions, may not address the etiology, it can potentially decrease the production of factors that contribute to neurotoxicity, thereby hopefully leading to clinical improvements.”
SNK01 is NKGen’s lead product candidate.3 In addition to the aforementioned indications, it is also currently being assessed in clinical trials as a monotherapy and as part of combination therapies with other treatments, such as checkpoint inhibitors and cell engagers, in patients with advanced refractory solid tumors. NKGen is also developing SNK02, an allogeneic NK cell therapy, which is currently being evaluated in a phase 1 clinical trial (NCT05990920) for solid tumors.5
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 April 30, 2024. https://nkgenbiotech.com/nkgen-biotech-announces-fda-clearance-of-investigational-new-drug-ind-application-for-snk01-nk-cell-therapy-in-parkinsons-disease/
2. NKMAX's NK cell therapy for Parkinson’s scores FDA compassionate use approval. News release. NKMAX. February 23, 2023. https://www.koreabiomed.com/news/articleView.html?idxno=20514
3. NKGen Biotech announces collaboration with the Parkinson’s Foundation to bring its novel natural killer cell therapy to the clinic for advanced Parkinson’s disease. News release. NKGen. Biotpech. Novemebr 4, 2022. https://nkgenbiotech.com/nkgen-biotech-announces-collaboration-with-the-parkinsons-foundation-to-bring-its-novel-natural-killer-cell-therapy-to-the-clinic-for-advanced-parkinsons-disease/
4. NKGen Biotech presented phase I clinical trial data at the 16th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference. News release. NKGen Biotech Inc. October 26, 2023. Accessed November 21, 2023. https://nkgenbiotech.com/nkgen-biotech-presented-phase-i-clinical-trial-data-at-the-16th-annual-clinical-trials-on-alzheimers-disease-ctad-conference/
5. NKGen Biotech, Inc. announces first patient dosed in phase I clinical trial of SNK02, allogeneic NK cell therapy product candidate, for the treatment of solid tumors. News release. NKGen Biotech, Inc. August 24, 2023. Accessed August 28, 2023. https://nkgenbiotech.com/nkgen-biotech-inc-announces-first-patient-dosed-in-phase-i-clinical-trial-of-snk02-allogeneic-nk-cell-therapy-product-candidate-for-the-treatment-of-solid-tumors/
