Shine-On Biomedical announced yesterday that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its HLA-G-targeting exosome drug delivery system, SOB100. This marks the first exosome-based new drug developed by a Taiwanese biotech company to enter clinical trials.
Following the FDA’s approval last December for its trispecific T-cell engager (TCE) antibody to enter Phase 1/2a clinical trials for multiple cancers, Shine-On has made another breakthrough. Its leading exosome-based drug, SOB100, has now applied for Phase 1 clinical trials with the FDA. The company anticipates generating clinical data from human trials this year, marking a significant milestone in new drug development.
Shine-On’s CEO, Hong-Zhe Jiang, explained that exosomes are naturally secreted vesicles that play a crucial role in intercellular communication. As drug delivery carriers, exosomes can encapsulate highly toxic or easily degradable drugs, reducing toxicity and side effects while enhancing therapeutic efficacy. The potential for industrial applications is immense.
For instance, doxorubicin—commonly known as Adriamycin—is a widely used chemotherapy drug, with global sales reaching NT$31.67 billion in 2023. However, its severe side effects range from nausea and hair loss to life-threatening cardiac toxicity, including myocarditis, heart failure, and arrhythmia. To mitigate these effects, liposomes are currently used as delivery carriers, but they are synthetically produced, have poor cellular compatibility, and are inefficiently absorbed by cells. Furthermore, liposomes lack strong tumor-targeting properties, leading to drug accumulation in normal tissues and increased toxicity. By contrast, exosome-based drug carriers with tumor-targeting properties can overcome these limitations. Shine-On is dedicated to developing exosome-based delivery systems specifically designed for cancer therapy, including the encapsulation of chemotherapy and nucleic acid drugs to enhance treatment efficacy.
SOB100 and its related products were recognized last year with a Special Nomination Award at the 11th Merck Group Advance Biotech Grant Program. The company also recently signed a technology licensing Memorandum of Understanding (MOU) with ESCO Aster, a leading exosome manufacturer in Singapore. Additionally, Shine-On has been invited to present at the JP Morgan Healthcare Conference, further solidifying its growing international recognition in new drug development. These achievements are expected to contribute to long-term revenue growth.
In response to Taiwan’s recent policy initiative to strengthen pharmaceutical self-sufficiency, Shine-On plans to leverage its SOB100 exosome-based delivery platform to collaborate with domestic pharmaceutical companies. By encapsulating generic chemotherapy drugs with SOB100, these products can be developed as 505(b)(2) modified new drugs for the global market.
Since its founding just over three years ago, Shine-On has developed two lead drug candidates—SOA101, a trispecific antibody, and SOB100, a tumor-targeting exosome-based therapy—both of which are expected to enter clinical trials this year. SOA101 is designed for treating lung, colorectal, breast, oral, and ovarian cancers. According to a GII market research report, no trispecific antibody drugs have been approved for market yet. In 2023, competing bispecific antibodies had a market size of $5.71 billion, which is projected to grow to $41.29 billion by 2030.
Additionally, Allied Market Research reported that the global market for exosome-based diagnostics and therapeutics was valued at $224 million in 2020 and is expected to reach $2.9 billion by 2030, with a compound annual growth rate (CAGR) of 29.4%. As technology advances and aging populations drive demand for innovative treatments, SOB100 is well-positioned to secure a strong market share upon its launch.
Shine-On’s Chairperson, Chiu-Ching Huang, expressed confidence in the company’s ongoing clinical trials, aiming to demonstrate the safety and efficacy of SOA101 and SOB100 in cancer treatment. Despite being a young company, Shine-On has already established two core technology platforms—trispecific T-cell engager antibodies and targeted exosome-based drug delivery—leading to the development of eight pipeline products. The company has also been recognized by Clarivate Analytics, which has listed it among the world’s top ten exosome drug developers. With the advancement of SOB100, following in the footsteps of SOA101, Shine-On hopes to provide cancer patients with more innovative treatment options, improving both safety and quality of life.
Resource: 國內首例 聖安生醫外泌體癌藥 SOB100申請美國人體臨床
