Low-dose ICT01 plus low-dose IL-2 safely and significantly increase the number of activated γ9δ2 T cells, CD8 T cells, and Natural Killer cells in patients with solid tumors
ImCheck Therapeutics presented today the first patient data from EVICTION-2, a Phase I/II clinical trial evaluating the combination of ImCheck’s lead program, ICT01, a γ9δ2 T cell-activating monoclonal antibody targeting BTN3A, combined with low-dose (LD) IL-2, to selectively expand the number of γ9δ2 T cells in relapsed/refractory patients with solid tumors. In a poster presentation at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held in Boston, ImCheck researchers and academic collaborators showed data of the combination’s ability to safely and reproducibly induce γ9δ2 T cell activation, expansion, and migration out of the circulation, which was accompanied by similar effects on CD8 T cells and Natural Killer cells (NKs).
In 6 out of 6 evaluable relapsed/refractory ovarian and colorectal cancer patients who had failed >5 lines of treatment, ICT01 (1 or 5 mg IV Day 1 of each cycle) plus LD IL-2 (1 or 2 MIU/m2 SC Days 1-5 of first 3 cycles) increased γ9δ2 T cells 2 to 9 times above baseline during each of the first three 21-day cycles. The combination also demonstrated the activation, mobilization, and proliferation of CD8 T cells and NKs, with slightly more modest effects on granulocytes, in most patients at lower ICT01 doses than shown in previously presented data of ICT01 monotherapy in a similar patient population (EVICTION trial). The safety profile for the combination exhibited no dose-limiting toxicities in the first 3 dose cohorts and tolerability remained consistent without any new or increased adverse reactions.
“The data presented today provide initial clinical evidence that ICT01 plus LD IL-2 can significantly increase the number of γ9δ2 T cells and other important immune cell populations that could generate a stronger anti-tumor immune response in heavily pre-treated solid tumor patients,” commented Paul Frohna, MD, PhD, Chief Medical Officer at ImCheck Therapeutics. “The combination’s safety profile is a positive outcome and is firmly in line with the results for ICT01 monotherapy and in combination with pembrolizumab that we have seen from over 100 cancer patients who have participated in the ongoing EVICTION trial.”
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About the EVICTION-2 Trial
EVICTION-2 is a first-in-human, dose escalation (Part 1) and cohort expansion (Part 2) clinical trial evaluating ICT01 in combination with low dose subcutaneous IL-2. The trial’s objective is to demonstrate the combination’s ability to selectively expand the number of γ9δ2 T cells in patients with solid tumors (prostate, pancreatic, ovarian, or colorectal cancer). For more information, please refer to https://clinicaltrials.gov and reference NCT05307874.