On June 2, China Medical University Hospital (CMUH) announced that a research team led by Superintendent Der-Yang Cho, in collaboration with Shine-On Biomedical, has successfully developed the world’s first targeted exosome drug delivery platform for HLA-G—SOB100. This breakthrough was published in the prestigious international journal Nature Communications and received approval from the U.S. FDA on March 8 to enter Phase I human clinical trials.
According to Der-Yang Cho, the SOB100 platform has completed preclinical studies and demonstrated promising results in treating difficult cancers such as breast cancer and glioblastoma.
Jennifer Ho, Vice President of Shine-On Biomedical, noted that SOB100 is the only exosome platform globally to utilize nanobody (VHH) technology to specifically target HLA-G on tumor cells and penetrate the blood-brain barrier. Multiple animal studies have confirmed its ability to accurately deliver a variety of drugs, effectively combating hard-to-treat breast and brain cancers. The FDA recognized SOB100’s high specificity and low immunogenicity in preclinical development as an exosome drug delivery platform.
HLA-G is typically only expressed in placental tissue in normal physiology but is overexpressed by many cancer cells to evade immune surveillance. Through genetic engineering, SOB100 embeds an HLA-G-targeting nanobody on the surface of exosome membranes, allowing precise delivery of encapsulated small molecule or nucleic acid drugs to HLA-G-expressing tumor cells. This significantly enhances therapeutic efficacy while reducing the toxicity commonly associated with traditional cancer treatments.
Hung-Che Jiang, CEO of Shine-On Biomedical, shared that Clarivate Analytics has listed Shine-On among the world’s top ten companies in exosome drug development. SOB100 not only leads in technology but has also earned multiple honors including the National Innovation Award, the International Innovation Award, and the Merck Emerging Biotech Special Award at its 11th program. The platform holds great promise in the global cancer and gene therapy markets as a potential replacement for viral and liposome-based drug delivery systems.
In addition, Shine-On has signed a memorandum of understanding (MOU) with a Singapore-based exosome company for the licensing and co-development of HLA-G-targeted exosome drug technology. The agreement includes methods for loading chemotherapeutic agents into exosomes. This collaboration will accelerate the global launch of the SOB100 drug series and broaden its applications in oncology.
Jiang emphasized that SOB100 offers an innovative solution to two long-standing challenges in cancer treatment: insufficient targeting and drug resistance. With its precise delivery and ability to selectively modulate the immunosuppressive tumor microenvironment, SOB100 is poised to become a benchmark platform for the delivery of nucleic acid and small molecule therapies, with strong potential for rapid market entry.
Resource: 中國附醫攜手聖安 靶向外泌體進軍美國臨床試驗
