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 promisingin vivoanti-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.