SHANGHAI, Nov. 5, 2023 /PRNewswire/ -- 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.

About KangaBio

KangaBio is a global biopharmaceutical company founded in 2021 by Dr. Wei Dong Jiang. The company specializes in discovery and development of novel cancer immunotherapies. KangaBoo utilizes their cutting-edge pre-drug protein engineering technology to create a new generation of immune modulators and multispecific antibodies. KangaBio mission is to address unmet cancer treatment worldwide. In over two years, KangaBio has developed a strong product pipeline with multiple candidate drug products. In June 2023, KangaBio secured over $13.6 million in a Pre-A financing round.

About Sanyou

Sanyou Biopharmaceuticals Co., Ltd. is a world-leading high-tech biotechnology enterprise focusing on R&D and services of innovative biologic drugs. Sanyou is committed to bridge drug R&D and all-life-cycle manufacture supply chain, and has built the 4C business patterns that integrate "differentiated CRO, integrated CDO, innovative CPO and characteristic CRS", to accomplish the mission "to make the R&D easy for innovative biologics".

Sanyou has established an integrated innovative biologic drug R&D laboratory of twenty thousand square meters with advanced facilities, and has a professional team of nearly 300 employees, with the majority holding a Ph.D. or master degree. Sanyou has built three industry-leading innovative technology platforms featured by "super-trillion, integration, and intelligence" , which are comprised of more than 50 sub-platforms with the core innovative super-trillion phage display platform, and supported by platforms of material preparation, biologics discovery, molecule optimization, in vitro and in vivo efficacy, production cell line construction, upstream and downstream process development, preclinical R&D, industrialization development, etc.

Sanyou's business network has expanded to all parts of the world, including Asia, US and Europe, and established branches in Boston, Philadelphia, San Diego, Rotterdam and London. Sanyou has established friendly business relationships with more than 1000 pharmaceutical companies, drug R&D institutions and diagnostics companies worldwide. Sanyou received National-level certification as a high-tech enterprise and a Specialized and Sophisticated enterprise, and passed the ISO9001 quality assurance certification and GB/T intellectual property management system certification.

Source: Sanyoubio