Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has unveiled Phase I clinical data for its innovative PD-1/IL-2α-biased bispecific antibody (BsAb) fusion protein, IBI363, at the 2024 World Conference on Lung Cancer (WCLC). The data, which pertain to the treatment of advanced non-small cell lung cancer (NSCLC), highlight the potential of this first-in-class therapy.
As detailed as of the August 2, 2024, data cutoff, 134 patients had been enrolled and received IBI363 monotherapy, with a dosage up to 3 mg/kg every three weeks. Notably, 95.5% of these patients had previously received PD-(L)1 immunotherapy. With a median exposure to IBI363 of 10 weeks and a treatment continuation rate of 77.6%, the drug demonstrated an overall objective response rate (ORR) of 20.8% and a disease control rate (DCR) of 74.4% among the 125 patients who had at least one post-baseline tumor assessment. These results indicate promising antitumor activity in patients with IO-resistant, driver gene wild-type NSCLC, with clinical benefits observed in both ORR and progression-free survival (PFS), alongside a favorable safety profile.
IBI363, developed in-house by Innovent, operates by blocking the PD-1/PD-L1 pathway and simultaneously activating the IL-2 pathway. The design of IBI363’s IL-2 arm is tailored to retain its affinity for IL-2Rα while diminishing binding to IL-2Rβ and IL-2Rγ, which helps to reduce toxicity. The PD-1 binding arm serves a dual function by blocking PD-1 and selectively delivering IL-2. This targeted approach activates tumor-specific T cells that express both PD-1 and IL-2Rα, leading to a more precise and potent activation of this critical T cell subset.- Flcube.com
