On November 4, 2023 KangaBio reported that the U.S. FDA has granted official approval for their independent R&D clinical trial application (IND) for KGX101 (Press release, KangaBio, NOV 4, 2023, View Source [SID1234636978]). KGX101 is a recombinant IL-12 Fc fusion protein designed for intravenous injection. The KGX101 clinical trials will be carried out simultaneously in both United States and Australia. These trials will primarily focus on late-stage solid tumors and the effectiveness will either be evaluated as a standalone therapy or in combination with anti-PD-L1 antibodies. Several research centers in Australia have already commenced patient screening for participation in these clinical trials.
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Sanyou Bio congratulates our partner, KangaBio on reaching this significant milestone. This achievement strengthens our 2022 strategic partnership, which is dedicated to advancing the development and innovation of antibody-based drugs. Sanyou Bio is pleased to have played a role in KangaBio’s preclinical efficacy evaluations for KGX101, revealing promising in vivo anti-tumor efficacy and safety outcomes. We are looking forward to gaining more insights into its performance during the clinical stage.
KGX101 is a prodrug of Interleukin-12 (IL-12) created using KangaBio’s proprotein technology platform. KGX101 has a prolonged half-life due to the use of the antibody Fc region. KGX101 becomes active specifically in tumors by fusing the protease-cleavable linker that targets tumors. This minimizes systemic cytokine toxicity when the linker is cleaved by tumor-specific matrix metalloproteinases in the tumor microenvironment, KGX101, similar to IL-12, activates immune cells within the tumor, reshaping the tumor microenvironment for therapeutic benefits.