NKGen Biotech Announces Positive SNK01 Clinical Trial Results Presented at the Society for Immunotherapy of Cancer (SITC) 2021 Annual Meeting
SANTA ANA, Calif., Nov. 15, 2021 (GLOBE NEWSWIRE) — NKGen Biotech, a subsidiary of NKMax, harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, today announced that data from a Phase 1/2a clinical trial, sponsored by NKMax, evaluating SNK01 (autologous natural killer cells) plus pembrolizumab in Non-Small Cell Lung Cancer (NSCLC) patients in Korea was presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) held November 10 – 14, 2021, in Washington, D.C.
The poster “Phase I/IIa randomized trial evaluating safety and efficacy of SNK01 plus pembrolizumab in patients with Stage IV Non-Small Cell Lung Cancer (NSCLC) who have failed first-line platinum-based therapy” was presented by NKMax on November 10th at the Industry Program Reception.
“We are extremely pleased to share promising clinical data showing safety and superior efficacy of our SNK01 autologous NK cell therapy in combination with pembrolizumab,” said Sangwoo Park, Chief Executive Officer of NKGen Biotech. “The results of the trial demonstrate that SNK01 can be safely combined with checkpoint inhibitors, resulting in meaningfully improved clinical outcomes, especially compared to the checkpoint inhibitor alone. We look forward to seeing similar results in other solid tumor settings as we continue the clinical development of SNK01.”
In this trial, eighteen patients with advanced Stage IV NSCLC who failed prior frontline platinum-based therapy were randomized 2:1 to received pembrolizumab every three weeks with +/- 6 weekly infusions of SNK01. Two dosing groups for SNK01 were evaluated in combination with pembrolizumab: 2×109 cells/dose and 4×109 cells/dose. The primary endpoint was safety and secondary endpoints were objective response rate (ORR), progression-free survival (PFS), overall survival, and quality of life.
The median PFS was superior in the SNK01 combination group and results were statistically significant (6.2 months vs. 1.6 months; p = 0.001). Furthermore, a dose response was noted as PFS in the higher 4×109 cells/dose SNK01+ pembrolizumab combination arm was 9.4 months compared to 1.6 months for the pembrolizumab only group. No new safety signals were seen when SNK was added to pembrolizumab.
In this trial, combination of SNK01 and pembrolizumab enhanced antitumor activity in advanced NSCLC patients, and suggests possible utilization of combining SNK01 with pembrolizumab. NKGen Biotech/NKMax will continue to explore SNK01 in various tumor settings, including the combination approach with different modalities.
About NKGen Biotech
NKGen Biotech, Inc., a subsidiary of NKMax, is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (NK) Cell therapeutics. Leveraging our proprietary cell expansion and activation technology and cutting-edge cell manufacturing expertise, we have the ability to infinitely expand natural killer cells while significantly enhancing cytotoxicity across our peripheral blood-derived products. NKGen Biotech’s lead product candidate, SNK01, is currently in Phase 1 and Phase 1/2a clinical trials for the treatment of advanced refractory solid tumors both as a monotherapy and in combination with other agents including checkpoint inhibitors and cell engagers. NKGen Biotech is committed to the vision of executing on our clinical strategies with the goal of commercializing our NK cell therapies to help save and sustain patients’ lives worldwide. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com.
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications