Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, IBI363. This PD-1/IL-2α bispecific antibody fusion protein is under development for the treatment of unresectable locally advanced or metastatic melanoma, excluding choroidal melanoma, in patients who have experienced disease progression following at least one prior systemic therapy regimen that included a PD-1/L1 inhibitor.
IBI363, a first-in-class drug candidate independently developed by Innovent, features a PD-1/IL-2 bispecific antibody fusion protein as its active ingredient. The drug’s IL-2 component has been meticulously engineered to enhance efficacy and minimize toxicity, while the PD-1 component is designed to block the PD-1 pathway and facilitate selective IL-2 delivery. This dual-action mechanism allows IBI363 to block the PD-1/PD-L1 pathway and activate the IL-2 pathway simultaneously, leading to more precise and effective targeting and activation of tumor-specific T cells. The drug has shown significant anti-tumor activity across various pharmacological tumor models and has demonstrated substantial antitumor efficacy in both PD-1 resistant and metastatic models. In addition, IBI363 has shown a favorable safety profile in preclinical models.
Clinical trials for IBI363 are currently in progress in China, the United States, and Australia, focusing on evaluating the drug’s safety, tolerability, and preliminary efficacy in subjects with advanced malignancies. The fast-track designation from the FDA underscores the potential of IBI363 to address a significant unmet medical need and could expedite its development and review process. – Flcube.com
