• SOT109 targets CDH17, a highly prevalent GI cancer antigen expressed in more than 90% of colorectal cancers, combining a clinically validated payload with an optimized ADC design intended to maximize therapeutic potential

• SOT109 is the only CDH17-targeting ADC to receive Fast Track Designation from the U.S. FDA, underscoring its potential to address a significant unmet need in colorectal cancer
• First-in-human CADENCIA-01 study initiates clinical evaluation of SOT109 in patients with advanced colorectal cancers, with initial safety and early efficacy signals within the next 12–18 months

• CADENCIA-01 is designed to rapidly establish clinical proof of concept in a large patient population, potentially positioning SOT109 as a best-in-class CDH17-targeting ADC

SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, today announced that the first participant has been dosed in its Phase 1/2 CADENCIA-01 clinical trial of SOT109 in colorectal cancer (CRC). SOT109 is a potentially best-in-class antibody-drug conjugate (ADC) exploiting the highly promising target of CDH17 for the treatment of CRC and other gastrointestinal cancers. As the only CDH17-targeting ADC that has been granted U.S. FDA Fast Track Designation, SOT109 is uniquely positioned within the emerging CDH17 landscape and has the potential to become a differentiated treatment option for patients with advanced gastrointestinal cancers.

“Dosing the first patient marks an important step as we advance SOT109 into the clinic and begin generating initial clinical data,” said Vivi Boura, M.D., chief medical officer of SOTIO. “Patients with advanced colorectal cancer continue to face limited treatment options after progression on standard therapies, highlighting the need for new targeted approaches. This study is designed to efficiently evaluate safety and early signs of anti-tumor activity in a well-defined population, with the goal of establishing a rapid path toward clinical proof of concept and supporting potential expansion into broader gastrointestinal indications.”

SOT109 targets CDH17, an antigen homogeneously overexpressed in more than 90% of CRC cases and abundantly expressed in other GI cancers. SOT109 combines a proprietary, highly internalizing, fully human antibody with Lonza’s proven ADC technology platform incorporating the SYNtecan E™ linker-payload (DAR=4). In CRC, the SYNtecan E™ linker-payload is expected to deliver superior activity, reduced susceptibility to resistance, and an enhanced bystander effect driven by high cell permeability, differentiating SOT109 from earlier-generation ADC payloads.

Preclinical data show robust anti-tumor efficacy for SOT109, with significant and sustained tumor regressions observed across several challenging in vivo colorectal tumor models. Studies in non-human primates demonstrated a compelling pharmacokinetic and safety profile.

The multicenter international Phase 1/2 CADENCIA-01 trial (NCT07693751) is a dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of SOT109 in patients with advanced unresectable or metastatic CRC who have exhausted standard approved treatment options. The study focuses on CRC as an initial, well-defined population with high target expression, enabling efficient signal detection and supporting a potential path to broader gastrointestinal expansion. The study will enroll patients in Europe and the U.S. An Investigational New Drug (IND) application has recently been cleared by the U.S. Food and Drug Administration (FDA).

SOT109 represents the first of SOTIO’s two next-generation ADC programs entering the clinic in 2026, reflecting the company’s broader strategy to build a differentiated solid tumor ADC franchise.