FDA Grants Fast Track Designation to SOTIO’s SOT109, a CDH17-targeting ADC for Colorectal Cancer

• Phase 1/2 trial of SOT109 in patients with advanced unresectable or metastatic colorectal cancer expected to commence in Q3 2026;

SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to SOT109, the company’s 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 CDH17, a highly prevalent antigen expressed in more than 90% of CRC cases and broadly across gastrointestinal malignancies, supporting the potential for broad clinical utility and a favorable therapeutic index.

"Advanced colorectal cancer remains an area of profound unmet need, particularly for patients whose disease has progressed after standard therapies," said Vivi Boura, M.D., chief medical officer of SOTIO. "SOT109 is designed to capitalize on the unique biology of CDH17, a highly prevalent target that is broadly and consistently expressed across colorectal tumors, while having limited expression in healthy tissues. We believe Fast Track Designation underscores both the urgent need for new treatment options and the potential of SOT109 to expand the benefits of targeted ADC therapy to a substantially broader patient population."

FTD enables more frequent interactions with the FDA regarding development strategy, clinical trial design and data requirements and may provide eligibility for accelerated approval and priority review, subject to applicable criteria.

SOTIO expects to initiate a Phase 1/2 trial of SOT109 in patients with advanced unresectable or metastatic CRC in Q3 2026.