FDA Grants Fast Track Designation to SOTIO’s SOT109 for Advanced Colorectal Cancer
Wednesday, July 15, 2026
SOTIO Biotech has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for SOT109, its investigational antibody-drug conjugate (ADC), for the treatment of patients with advanced unresectable or metastatic colorectal cancer (CRC) who have exhausted standard treatment options.
SOT109 targets CDH17, an antigen found in more than 90% of colorectal cancer cases and widely expressed across gastrointestinal cancers. The company believes this could support broad clinical use while limiting effects on healthy tissues.
The FDA's Fast Track Designation is intended to support the development of treatments for serious conditions with unmet medical needs. The designation allows for more frequent interactions with the FDA during clinical development and may provide eligibility for accelerated approval and Priority Review, subject to regulatory requirements.
SOTIO said the designation highlights the need for new treatment options for patients with advanced colorectal cancer and supports the continued clinical development of SOT109 as a potential targeted therapy for this patient population.
Source: globenewswire.com
