Allogeneic Natural Killer Cell Therapy Given Go-Ahead for Solid Tumors


NKGen plans to initiate a phase 1 trial pd SNK02 in the first quarter of 2023.

The FDA has given investigational new drug application (IND) clearance to NKGen’s SNK02, an allogeneic natural killer (NK) cell therapy for treating solid tumors.1

“We are excited to be able to proceed with our SNK02 clinical trial plans for treating refractory cancer patients who are left with limited options,” Paul Song, MD, vice chairman, NKGen Biotech, said in a statement.1 “I believe that SNK02 is the first cryopreserved allogeneic NK cell therapy that does not require lymphodepletion before administration unlike other cell therapies.”

With the IND clearance, NKGen will soon commence a multicenter, open-label, dose-escalation phase 1 study of the cryopreserved SNK02 in participants with solid tumors refractory to at least 1 standard of care therapy.The study will primarily evaluate safety and tolerability of the therapy as well as determine the maximum tolerated dose. NKGen expects to initiate the study in the US in the first quarter of 2023.

SNK02 is manufactured using NKGen’s patented process to producea large quantity of NK cells with a high level of purity and receptor expression. In addition, the company's cryopreservation process allows the therapy to retain potency in its antitumor activity.

READ MORE: Devon J. Shedlock, PhD, on Shifting from Autologous to Allogeneic Therapies

“This clearance for SNK02 is an important milestone in our pursuit to bring life-changing therapies to cancer patients and will be our second clinical NK cell therapy program focusing on solid tumors, following our SNK01 autologous product entering Phase 2 studies next year,” Song added.1

In September 2022, NKGen published positive data on its lead NK cell therapy candidate, SNK01, in advanced sarcoma.2 The data is from 2 case studies of patients with desmoplastic small round cell tumor and radiation-induced chondrosarcoma treated with 2x109 cells of SNK01 intravenously plus 200 mg pembrolizumab intravenously every 3 weeks. Both patients’ tumors gradually decreased in size, with patient 1 achieving a 47% partial response, undergoing 2 surgical resections and achieving a sustained response and patient 2 achieving a 38% partial response.

“We are pleased to be able to share the promising results of our SNK01 natural killer cell therapy in combination with pembrolizumab, in these 2 important case studies since metastatic sarcoma is typically associated with poor outcomes when treated with standard regimens,” Song said in a statement at that time.3 “It is encouraging to see that patient #1, despite being PD-L1 negative and having failed prior pembrolizumab... achieved a sustained remission. Of note is that the patient has safely been on this regimen for almost 35 months without any toxicity at all and remains no evidence of disease.”

1. NKGen Biotech receives IND clearance from FDA for SNK02 allogeneic natural killer cell therapy for solid tumors. News release. NKGen Biotech. October 17, 2022.
2. Gorden EM, Chawla SP, Chua-Alcala VS, et al. Durable Responses Using SNK01 Autologous Enhanced Natural Killer Cells and Pembrolizumab for Chemotherapy-Resistant Advanced Sarcoma: Case Reports, Review of Literature and Future Perspectives. J. Cancer Res. Cell Ther. 6(5); doi:10.31579/2640-1053/126
3. NKGen Biotech announces publication in Journal of Cancer Research and Cellular Therapeutics on durable response for SNK01 in advanced sarcoma. News release. NKGen Biotech. September 21, 2022.
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