Tumor microenvironment (TME) of solid tumors is more complicated compared to hematological tumors . Many current treatment modalities, including immune checkpoint inhibitors (ICIs), have demonstrated limited efficacy with only 20-30% of patients benefiting due to high rates of drug resistance. Shine-On has developed a next-generation nano-based antibody drug against cancer, i.e., "Nanobody-based Trispecific T Cell Engager, Nb-TriTE (SOA101)”. SOA101 is designed with three specific antibodies, two of which are against immune checkpoints on tumor cells (PD-L1 and HLA-G) for reduction of drug resistance to ICIs by change on tumor microenvironment. The third antibody can bind to CD3 of T cells, which allows SOA101 to locally activate T cells and enhance T cell mediated tumor cytotoxicity. Moreover, nanobody-based VHHs has a high affinity to the targets, which increases the specificity, reduces side effects, and improves the patient safety of SOA101. SOA101 is a broad spectrum anticancer drug expected to apply for the treatment of lung cancer, H&N cancer, breast cancer, ovarian cancer, colorectal cancer and other solid tumors. According to a report from WHO, lung CA is the second most common cancer in the world. In the Asia-Pacific region, non-small cell lung cancer (NSCLC), accounting for 80-85% of lung cancer, is usually in an advanced stage when diagnosed; the 5-year survival rate is very low, even with target therapy, ICIs and chemotherapy treatment, 15.1% in stage III and 6% in stage IV. Late stage NSCLC is an unmet medical need and effective new drug development is an emergent. The product is expected to be at Clinical Phase regulated by US FDA in 2025.

1. First in the world with a tri-specific T-cell engager targeting two immune checkpoints.
2. The only nanobody-based tri-specific antibody drug worldwide.
3. Taiwan’s first trispecific antibody drug to apply for US FDA IND.
4. The preclinical data have been published in a high-impact (IF: 14.3) journal - Advanced Science.
5. Broad-Spectrum Anticancer Drug: Our novel anticancer drug offers broad-spectrum treatment, encompassing but not limited to lung cancer, oral cancer, breast cancer, ovarian cancer, and other solid tumors.