26 August 2026: SOTIO’s SOT106 granted FDA Fast Track Designation for Soft Tissue Sarcoma
SOTIO announced that the U.S. FDA has granted Fast Track Designation to SOT106, an LRRC15-targeted ADC, for the treatment of patients with soft tissue sarcoma, supporting accelerated clinical development of the candidate
The designation supports SOTIO’s plans to advance SOT106 into the clinic, with the first-in-human study expected to begin in 2026, marking an important milestone in the program’s development
The program addresses a significant unmet need in soft tissue sarcoma, where treatment options remain limited and outcomes for patients with advanced disease continue to be challenging
SOT106 is an LRRC15-targeted ADC based on SOTIO’s proprietary antibody and LigaChem Biosciences’ ConjuAll ADC platform, designed to selectively deliver a cytotoxic payload to LRRC15-expressing tumor cells
Strategically, the Fast Track designation accelerates SOT106’s clinical development and strengthens SOTIO’s position in the ADC landscape, while supporting the company’s expansion into soft tissue sarcoma and broader development of its proprietary ADC pipeline