ImCheck Announces Initiation of US Enrollment in Phase 1/2a EVICTION Trial for ICT01

ImCheck Therapeutics recently announced the first patient in the US has been dosed at the Yale University Cancer Center in New Haven, CT, as part of the company’s ongoing EVICTION clinical trial evaluating ICT01 as monotherapy in patients with solid and hematologic malignancies, also in combination with anti-PD-1 inhibitors. The trial, initiated in March 2020, is enrolling patients at clinical sites across Europe and now the US, with additional US clinical trial sites to include Moffitt Cancer Center, Tampa, FL, and the University of Washington/Seattle Cancer Care Alliance.

“Current immunotherapies are proving to be beneficial for patients with some cancers, but we need new approaches and treatments to extend these advances to more patients,” said Dr. Patricia LoRusso, Associate Center Director for Innovative Medicine at the Yale University Cancer Center, and Investigator in the EVICTION trial. “I believe the gamma9 delta2 T cell activation seen to date with ICT01 has great potential and we are excited to be the first US clinical center to enroll for EVICTION.”

“Expanding the EVICTION trial into the US achieves a key milestone in our international clinical development strategy and follows the recent oral presentation of patient data demonstrating ICT01’s activation of the anti-tumor immune responses of gamma9 delta2 T cells at the AACR Annual Meeting 2021,” said Pierre d’Epenoux, Chief Executive Officer at ImCheck Therapeutics. “With three leading US cancer centers participating in our EVICTION study, we continue to build our presence in the US and raise awareness for our first-in-class candidate. On behalf of the ImCheck team, I would like to thank the trial investigators and their teams in the US as well as in Europe for their tireless efforts that support ICT01’s progress.”

EVICTION is a first-in-human, dose escalation (Part 1) and cohort expansion (Part 2) clinical trial of ICT01 in patients with various advanced solid or hematologic cancers that have exhausted standard of care treatment options. Part 1 is a basket trial designed to characterize the preliminary safety, tolerability, and pharmacodynamic activity of ICT01 as monotherapy (Group A: solid tumors; Group B: hematologic tumors) and in combination with pembrolizumab (Group C: solid tumors). Group A includes bladder, breast, colorectal, gastric, melanoma, ovarian, prostate, and pancreatic cancer, Group B includes AML, ALL, follicular lymphoma, and diffuse large B cell lymphoma, and Group C includes bladder, HNSCC, melanoma, and NSCLC. Basket trials represent a clinical trial design that allows new drugs to be tested rapidly in a range of indications, providing initial results on multiple parameters that can contribute to an accelerated development timeline. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates gamma9 delta2 (γ9δ2) T cells, which are part of the innate immune system that is responsible for immunosurveillance for malignancy and infection. The 3 isoforms of BTN3A targeted by ICT01 are expressed on the surface of innate (eg, γδ T cells and NK cells) and adaptive immune cells (T cells and B cells) and are overexpressed on a number of solid tumors (eg, bladder, colorectal, melanoma, ovarian, pancreatic, lung) and hematologic cancers (eg, leukemia & lymphoma). BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells.

ICT01 selectively activates circulating γ9δ2 T cells that leads to migration of γ9δ2 T cells out of the circulation and into target tissue (eg, tumors or infection site), while also activating the tumor-resident γ9δ2 T cells to directly kill malignant cells, which is accompanied by secretion of two key inflammatory cytokines, IFNg and TNFa, that expand the anti-tumor immune response. ICT01 has been shown to have anti-tumor activity against a range of cancers in in vitro and in vivo tumor models.

ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic antibodies positioned at the crossroads of two high-potential immunological fields: γ9δ2 T cells and butyrophilins (BTN), a novel super-family of checkpoint molecules. Due to their mechanism of action, and notably their ability to simultaneously modulate innate and adaptive immunity, ImCheck’s “first-in-class” activating antibodies may be able to produce superior clinical results as compared to the first-generation of immune checkpoint inhibitors and when used in combination to overcome the resistance to this group of agents. In addition, preclinical experiments with ImCheck’s antagonist antibodies are being evaluated as potential treatments for autoimmune diseases.