Dr. Hui Zhou, Senior Vice President of Innovent , stated: "We are pleased to present the Phase 1 results of IBI363 at ASCO. IL-2 is one of the earliest immunotherapies approved for cancer treatment, however, the safety and efficacy of IL-2 therapy have not been satisfactory.
IBI363, a novel PD-1/IL-2 bispecific molecule, designed to selectively activates PD-1 and CD25 positive T cells by cis-activating IL-2, with the potential to significantly decrease toxicity related to IL-2 and potentially overcome immunotherapy resistance. We are excited that in the Phase 1 study, IBI363 achieved unprecedented dosing levels, overcoming safety concerns associated with IL-2 therapy. Meanwhile, as IBI363 monotherapy has already shown efficacy signals and good tolerability in IO failed melanoma (most patients with mucosal or acral subtypes) and non-small cell lung cancer, cold tumors such as colorectal cancer and several other tumor types.
These results suggest the broad-spectrum anti-tumor effect of IBI363. This study is ongoing to further explore the long-term benefits and the potential optimal dose of IBI363. As immunotherapy moves into the next era, we are actively advancing the development of next-generation immune medicines, and hope to benefit more patients in need.
" Phase 1 Study of PD-1/IL-2 α (IBI363) in Melanoma, Colorectal Cancer and Other Solid Tumors This Phase 1a/1b study was conducted to evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with adv.