troculeucel (SNK01)

P1/2, N=11, Terminated, NKGen Biotech, Inc. | N=121 --> 11 | Trial completion date: Nov 2025 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Sep 2023; Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.

P1, N=10, Terminated, NKGen Biotech, Inc. | N=30 --> 10 | Recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Aug 2023; The study was terminated after completing the dose escalation portion of the study. The expansion cohort was not initiated to conduct a global trial based on the approved US IND using a new manufacturing process.

P1/2, N=36, Recruiting, NKGen Biotech, Inc.

P1, N=27, Completed, NKGen Biotech, Inc. | Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Feb 2023

SNK01 was safe and well tolerated. SNK01 appears to have clinical activity in AD while reducing neuroinflammation and protein levels. These results justify a larger trial with a higher dosing and longer treatment duration which will be initated in late 2023.

P1, N=27, Active, not recruiting, NKGen Biotech, Inc. | Trial completion date: May 2023 --> Sep 2023

Autologous NK cells can enhance the long-term OS and PFS for NSCLC. A larger study is needed to confirm this result. Clinical Research Information Service number: KCT0003463.

Efficacy will also be assessed by assessing progression-free and overall survival. Secondary endpoints for both phases include treatment-emergent adverse events, serious adverse events, pharmacokinetics and immunogenicity.

Furthermore, the median PFS was higher in the SNK01 combination group (6.2 vs. 1.6 months; p=0.001). Based on the findings of this study, the NK cell combination therapy may consider as a safe treatment method for stage IV NSCLC patients who had a history of failed platinum-based therapy without an increase in adverse events (AEs).

After completing the 3 Cohorts of single dose escalation of SNK01, the protocol was amended to include Cohort 4 (n=18) wherein SNK01 is given in combination with an immune checkpoint inhibitor (avelumab or pembrolizumab). The trial is currently in progress and 16/18 patients have been enrolled to date.

P1/2, N=24, Recruiting, NKMAX Co., Ltd. | Not yet recruiting --> Recruiting

P1/2, N=0, Withdrawn, NKGen Biotech, Inc. | N=154 --> 0 | Not yet recruiting --> Withdrawn

P1/2, N=24, Not yet recruiting, NKMAX Co., Ltd.

P1/2, N=154, Not yet recruiting, NKMax America, Inc. | Initiation date: Aug 2020 --> Mar 2021

These preliminary results demonstrate that combination therapy with Pembrolizumab and SNK01 is very safe and even appears to reduce checkpoint associated toxicity while increasing overall tumor response compared to Pembrolizumab monotherapy alone in Stage IV NSCLC patients who have failed prior platinum-based treatment. Research Funding: NKMAX

These preliminary results demonstrate that combination therapy with Pembrolizumab and SNK01 is very safe and even appears to significantly reduce checkpoint associated toxicity while increasing overall tumor response compared to previously reported Pembrolizumab monotherapy alone results in patients with advanced solid tumors. We plan to investigate this further with a much umbrella larger study.