Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced the results of a Phase Ia/Ib clinical trial for its investigational PD-1/IL-2 bispecific antibody fusion protein, IBI363. The study’s findings were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024, highlighting the molecule’s potential in treating multiple advanced solid tumors.
As of the cutoff date, April 16, 2024, a total of 347 patients with advanced solid tumors had been administered various doses of IBI363 as a monotherapy. The trial reported that the most frequent treatment-related adverse events (TRAEs) were joint pain, anemia, and thyroid dysfunction, with an overall incidence of TRAEs at level three or above recorded at 23.9%. In terms of efficacy, the 3mg/kg dose group showed an objective response rate (ORR) of 46.7% and a disease control rate (DCR) of 80.0% among the 15 subjects who underwent at least one post-baseline tumor assessment. IBI363 demonstrated promising therapeutic signals and a favorable safety profile across various tumor types, including non-small cell lung cancer, melanoma, and colorectal cancer.
IBI363 is a first-in-class candidate independently developed by Innovent, designed to combine the benefits of PD-1 blockade with the potent T-cell activation of IL-2. The molecule’s IL-2 arm has been optimized for enhanced efficacy and reduced toxicity, while the PD-1 arm facilitates selective IL-2 delivery. This dual-action mechanism allows for precise targeting and activation of tumor-specific T cells. IBI363 has shown promising anti-tumor activity across a range of preclinical models, including those with PD-1 resistance and metastasis. The compound is currently under clinical investigation for its efficacy and safety in multiple advanced malignancies in China, the United States, and Australia.- Flcube.com
