ICT01

P1/2, N=150, Recruiting, ImCheck Therapeutics | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Mar 2024 --> Jun 2025

P1/2, N=100, Recruiting, ImCheck Therapeutics | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Apr 2024 --> Apr 2025

ICT01, a first-in-class anti-BTN3A mAb activating γ9δ2 T cells, completed Phase 1 testing in relapsed/refractory (r/r) solid tumors as monotherapy and in combination with pembrolizumab, and as monotherapy in r/r AML and lymphoma (EVICTION-NCT04243499). Encouraging results obtained in the EVICTION Phase 1 trial and preclinical demonstration of the benefit of using ICT01 plus VEN/AZA allowed the initiation of a Phase 2a expansion cohort to evaluate the clinical benefit of this combination in 1L AML patients.

However, the pharmacodynamic effects of ICT01 are dependent on the number of circulating gamma9d2 T cells, which is low in most advanced cancer patients. Preclinical studies showed that ICT01 plus IL-2 induces selective expansion of gamma9d2 T cells with minimal Treg expansion supporting an ongoing Phase I/IIa (EVICTION-2) in patients with advanced-stage solid tumors.

P1/2, N=150, Recruiting, ImCheck Therapeutics | Trial completion date: Dec 2022 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Mar 2024

BTN3A targeting agonist antibody ICT01 is being developed in a multicentric Phase 1 and 2 study called EVICTION by Imcheck Therapeutics...ALL samples were also tested for their expansion capacities after 14 days of PBMC culture in presence of Zoledronate...These results indicate that the sensitization of leukemic cells can be induced by activation BTN3A as reported previously as well as with BTN2A1 mAbs. These findings could be of great interest for the design of innovative Vγ9Vδ2 T cells-based immunotherapy strategies for treating ALL that could be extended to other cancer types.

P1/2, N=150, Recruiting, ImCheck Therapeutics | Phase classification: P1 --> P1/2

BTN3A molecules are targeted at clinical level, with the ICT01 agonist monoclonal antibody (mAb), that is currently tested in a multicentric phase ½ study (EVICTION study)...These data bring novel understanding on the biology of BTN2A1 on leukemic cells and our ability to enhance both binding and function. These findings could be of great interest for the design of innovative Vγ9Vδ2 T cells-based immunotherapy strategies for treating ALL that could be extended to other cancer types.