SOTIO receives FDA Fast Track Designation for CDH17-targeting ADC SOT109 for CRC

CAR-T Digest - August 2020

Weekly Digest - July 2026

14 July 2026: SOTIO receives FDA Fast Track Designation for CDH17-targeting ADC SOT109 for CRC

SOTIO has received U.S. FDA Fast Track Designation for SOT109, its CDH17-targeting antibody-drug conjugate, for the treatment of patients with advanced unresectable or metastatic colorectal cancer who have progressed after available standard therapies, highlighting the potential of the program to address a significant unmet medical need in gastrointestinal oncology
The designation is expected to support the accelerated clinical development of SOT109 through enhanced regulatory interactions and potential expedited review pathways as the company advances the ADC toward a phase 1/2 clinical trial in patients with advanced colorectal cancer
The program addresses a major unmet need in metastatic colorectal cancer, where treatment options remain limited following progression on standard therapies. CDH17 is expressed in more than 90% of colorectal cancers and is broadly present across gastrointestinal malignancies, supporting its potential as a highly relevant therapeutic target
SOT109 is a CDH17-directed ADC incorporating Synaffix’s GlycoConnect and HydraSpace technologies with an exatecan-based payload, designed to enable targeted delivery of a potent topoisomerase I inhibitor while enhancing therapeutic index and minimizing off-target toxicity
Strategically, the Fast Track Designation strengthens SOTIO’s expanding ADC portfolio, validates its focus on developing differentiated best-in-class ADCs for solid tumors, and reinforces the company’s position in the emerging gastrointestinal oncology ADC landscape as it advances multiple clinical-stage programs