On October 26, 2023, KangaBio announced that the U.S. FDA has granted official approval for their independent R&D clinical trial application (IND) for KGX101. 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.
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.