Phase 1/2 trial in patients with advanced unresectable or metastatic colorectal cancer expected to begin in the third quarter of 2026
PRAGUE, BASEL, Switzerland, and BOSTON, July 14, 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 to SOT109, an antibody-drug conjugate (ADC) the company is developing for patients with advanced unresectable or metastatic colorectal cancer whose disease has progressed despite standard treatment.
SOT109 is designed to target CDH17, an antigen the company says is present in more than 90% of colorectal cancer cases and expressed broadly across other gastrointestinal cancers as well. Because CDH17 is found at low levels in healthy tissue but consistently expressed in tumors, SOTIO believes the target offers an opportunity to treat a large share of colorectal cancer patients while limiting effects on normal tissue – a combination the company hopes will translate into a favorable therapeutic index and support best-in-class potential for the program.
SOTIO’s chief medical officer, Vivi Boura, M.D., said the designation reflects both the scale of unmet need in colorectal cancer, particularly among patients who have run out of standard options, and the opportunity CDH17 presents as a target that is both prevalent and largely tumor-specific. She noted that the company sees SOT109 as a path to bringing targeted ADC therapy to a much wider group of colorectal cancer patients than current approaches reach.
What Fast Track Designation Means
Fast Track Designation is an FDA program intended to speed the development and review of therapies that address serious conditions and demonstrate the potential to fill unmet medical needs. Programs that receive the designation benefit from more frequent communication with the FDA on trial design, data requirements, and overall development strategy. Depending on how the data evolve, Fast Track–designated therapies may also become eligible for accelerated approval and priority review.
Next Steps For SOT109
SOTIO plans to open a Phase 1/2 clinical trial evaluating SOT109 in patients with advanced unresectable or metastatic colorectal cancer in the third quarter of 2026. The study will mark the compound’s entry into clinical development.
About SOT109 And SOTIO’s ADC Pipeline
SOT109 is one of two lead ADC programs at SOTIO. Alongside SOT109, the company is developing SOT106, which targets LRRC15 for sarcoma and other solid tumors and received FDA Orphan Drug Designation in May 2026; SOT106 remains in preclinical development. Both programs are designed to move efficiently toward early clinical proof of concept.
SOTIO’s broader pipeline also includes SOT201, a next-generation immunocytokine targeting PD-1, which is currently being studied in the Phase 1 VICTORIA-01 trial in patients with solid tumors.
About SOTIO Biotech
SOTIO Biotech is a clinical-stage biopharmaceutical company focused on developing next-generation antibody-drug conjugates for solid tumors, with an emphasis on cancers that carry significant unmet need and the potential for broad patient applicability. The company is part of PPF Group. More information is available at www.sotio.com.
SOTIO is a registered trademark of SOTIO Biotech a.s. in selected countries.
Contacts
Company Contact Richard Kapsa Head of Communication T: (+420) 224 174 448 M: (+420) 603 280 971 [email protected]
Media Contact Lisa Raffensperger Ten Bridge Communications M: +1 (617) 575-2647 [email protected]