China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received another fast-track designation from the US Food and Drug Administration (FDA) for its IBI363. The PD-1/IL-2α bispecific antibody fusion protein, previously granted fast-track status for melanoma, has now been awarded the designation for the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy.
Drug Details
IBI363, a first-in-class drug candidate independently developed by Innovent Biologics, contains an active ingredient known as the PD-1/IL-2 bispecific antibody fusion protein. The IL-2 component of IBI363 has been engineered to maximize efficacy and reduce toxicity, while the PD-1 binding component achieves PD-1 blockade and selective IL-2 delivery. This dual mechanism allows IBI363 to simultaneously block the PD-1/PD-L1 pathway and activate the IL-2 pathway, enabling more precise and efficient targeting and activation of tumor-specific T cells. IBI363 has demonstrated significant anti-tumor activity in various tumor-bearing pharmacological models and has shown notable antitumor efficacy in both PD-1 resistant and metastatic models.
Clinical Development
Clinical studies of IBI363 are currently underway in China, the United States, and Australia to evaluate its safety, tolerability, and preliminary efficacy in subjects with advanced malignancies.-Fineline Info & Tech
