FDA Grants Fast Track Designation to SOTIO Biotech's SOT109 (CDH17-Targeting Antibody-Drug Conjugate) for Advanced Unresectable or Metastatic Colorectal Cancer on Tuesday July 14: CDH17 Is Expressed in More Than 90% of Colorectal Cancer Cases and Broadly Across Gastrointestinal Malignancies, and SOTIO Expects to Initiate a Phase 1/2 Trial in Q3 2026 With the Broader ADC/PDC Payload-and-Linker Race Continuing to Build on Novartis's July 6 Myricx Acquisition and Lonza's July 2 Nona Biosciences TfR1 BBB Deal
SOTIO Biotech (a portfolio company of PPF Group) announced Tuesday July 14, 2026 that the US Food and Drug Administration (FDA) granted Fast Track Designation to SOT109, its investigational potentially best-in-class 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 cadherin 17 (CDH17), a cell-surface antigen expressed in more than 90% of CRC cases and broadly across gastrointestinal malignancies, supporting the case for broad clinical utility and a favorable therapeutic index. SOTIO expects to initiate a Phase 1/2 trial of SOT109 in patients with advanced unresectable or metastatic CRC in Q3 2026. Fast Track Designation allows more frequent FDA-sponsor interactions and eligibility for accelerated approval and priority review if criteria are met. The SOT109 program extends the broader payload-and-linker-chemistry investment thesis anchored by Novartis's July 6 Myricx Bio $1.5 billion NMTi acquisition and Lonza's July 2 Nona Biosciences TfR1 BBB-delivery deal.