NKMAX Completes Phase 1/2a Clinical Trial of Super NK Immuno-Oncology Drug

[Asia Economy Reporter Hyunseok Yoo]NKMax announced on the 27th the completion of the Korean Phase 1/2a clinical trial of the SuperNK immuno-oncology drug.

This clinical trial involved 20 non-small cell lung cancer (NSCLC) patients who had failed first-line platinum-based therapy and had no prior experience with immune checkpoint inhibitor treatment. The study tested the combination of the immune checkpoint inhibitor 'Keytruda' (generic name: Pembrolizumab) and 'SNK01' (SuperNK autologous immuno-oncology drug). According to the company, the last patient dosing was completed at the end of May last year, followed by a one-year follow-up period, leading to this declaration of trial completion.

NKMax previously presented interim results at ASCO2020 for 9 patients out of the total 20 enrolled in the Phase 1/2 trial: 8 patients in the control group receiving Keytruda monotherapy and 12 patients in the treatment group receiving Keytruda plus SNK01 combination therapy. A company representative explained that, consistent with the excellent interim results presented at ASCO2020, the combination therapy group showed a superior Objective Response Rate (ORR) compared to the Keytruda monotherapy group, along with a statistically significant increase in Progression Free Survival (PFS).

The final results of the clinical trial will be announced after data analysis. Simultaneously, preparations for the Phase 2B trial are underway, with plans to start within this year. Additionally, the clinical trial results will be submitted to a major international conference scheduled for the second half of the year.

Professor Changmin Choi, who led the clinical trial, stated, "This trial is the first successful study combining Keytruda and NK cell therapy in NSCLC patients, confirming superior therapeutic effects in the SNK01 combination group compared to the Keytruda monotherapy group. We plan to evaluate the efficacy of the SuperNK immuno-oncology drug in a larger patient population in the future, and we believe NKMax's SuperNK immuno-oncology drug will become a powerful treatment option for patients with solid tumors," expressing his expectations.