Dose Level
Agent-797
(No. cells)
No. Patients
No. Discharged
No. Deaths
MiNK Presentation SITC 2021
PERSISTENCE AND TISSUE DISTRIBUTION OF AGENT-797
a native allogeneic iNKT cell therapy
Marco A. Purbhoo, Burcu Yigit, Darrian Moskowitz, Ayat Alsaraby, Maurice Kirby, Anitha Swarna, Valeriia Nasonenko, Ilya Mishchenko, Sonia De Munari, Waldo Ortuzar, Koen Van Besien, Don Stevens, Terese Hammond, Xavier Michelet, Marc van Dijk
November 12, 2021
Novel iNKT Cell Therapy, AgenT-797, Demonstrates 77% Survival in Phase 1 Study to Treat Intubated ARDS COVID-19 Patients at SITC
Single infusion of agenT-797 demonstrated a pronounced survival rate of 77% in mechanically ventilated elderly COVID-19 patients with moderate to severe ARDS. 13 patients have been treated to date, with 8 patients discharged and 2 patients ongoing. This represents an improvement compared to a National average of approximately 40 % (range 24-53%) for intubated or mechanically ventilated patients during time of enrollment.
77% overall survival in intubated ICU Patients with ARDS (COVID-19)
1
100 x 106
3
2
1
2
300 x 106
4
3
1
3
1000 x 106
6
3
1
Phase 1 study to evaluate the safety and efficacy of agenT-797, an unmodified, allogeneic iNKT cell therapy, in patients with acute respiratory distress syndrome (ARDS) secondary to COVID-19, requiring mechanical ventilation
Dose Level 1
Agent-727(No. cells): 100 x 1016
No. Patients: 3
No. ongoing: ---
No. discharged: 2
No. deaths: 1
Dose Level 2
Agent-727(No. cells): 300 x 1016
No. Patients: 4
No. ongoing: ---
No. discharged: 3
No. deaths: 1
Dose Level 3
Agent-727(No. cells): 1000 x 1016
No. Patients: 6
No. ongoing: ---
No. discharged: 4
No. deaths: 1
Phase 1 study to evaluate the safety and efficacy of agenT-797, an unmodified, allogeneic iNKT cell therapy, in patients with acute respiratory distress syndrome (ARDS) secondary to COVID-19, requiring mechanical ventilation.
AgenT-797 can be administered tolerably up to 1000 x 106 cells/dose without neurotoxicity or cytokine release syndrome
6 patients have been treated at the maximal dose level and no dose limited toxicities have been observed. These patients are heavily pre-treated with a median age of 69 (49-77).
Baseline Demographics
Characteristic
All Patients
(n=13)
Media Age Range
69 (49-77)
Sex, n (%)
Male
3 (23)
Female
10 (77)
Co-medications, n
Remdesivir
Steroids
5
Remdesivir
Steroids
Tocilizumab
5
Other
3
Initial data translational data confirmed the trafficking ability of these tissue resident cells, showing the translocation of iNKTs
MiNK developed a digital PCR-based method to characterize agent-797 in patients; analyses of tissue distribution, persistence, and functional capacity of agent-797 are underway.
Key observations:
- Initial spike of agent-797 cells in peripheral blood observed post-infusion
- Detection of agent-797 in peripheral blood up to day 6 of treatment
- Detected level scales with dose level
- Data consistent with the expected rapid translocation of iNKT cells from blood into tissue
- Method can be validated for any tissue
