SOT109 / Sotio, Lonza - LARVOL DELTA

A Study to Assess Safety and Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: SOTIO Biotech a.s. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Colorectal Cancer • Oncology • Solid Tumor

SOTIO Doses First Patient in Phase 1/2 CADENCIA-01 Clinical Trial of SOT109, a CDH17-Targeting ADC for Colorectal Cancer (GlobeNewswire) - "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 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)."

First-in-human • IND • Trial status • Colorectal Cancer

A Study Testing SOT109 for the First Time in Patients, to Assess How Safe SOT109 is, How Well it Works, and How the Body Handles it in Patients With Advanced Colorectal Cancer That Can Not be Removed by Surgery or is Metastatic (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: SOTIO Biotech a.s.

First-in-human • New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor

FDA Grants Fast Track Designation to SOTIO’s SOT109, a CDH17-targeting ADC for Colorectal Cancer (The Manila Times) - "SOTIO expects to initiate a Phase 1/2 trial of SOT109 in patients with advanced unresectable or metastatic CRC in Q3 2026."

Fast track • Trial status • Colorectal Cancer

Preclinical safety and efficacy of SOT109, an antibody-drug conjugate targeting cadherin 17 (CDH17) for the treatment of colorectal and other gastrointestinal tract tumors (AACR 2025) - "Immunohistochemical staining of patient tumor and healthy tissue microarrays confirmed CDH17 expression in normal tissues including the colon, stomach and small intestine, with pronounced expression in colorectal, gastric, and gastroesophageal junction tumors, consistent with previously published literature. SOT109 candidates were generated from a fully human CDH17 monoclonal antibody conjugated via a hydrophobic linker to exatecan, a cytotoxic topoisomerase I inhibitor payload. Candidates were selected by rigorous screening for optimal binding epitopes and affinity, together with binding, internalization, and cytotoxicity in vitro."

ADC • Preclinical • Colorectal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CDH17

SOT109, SOTIO’s lead CDH17-targeting ADC for gastrointestinal cancers… (Businesswire) - "SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, today announced it will present new preclinica...data...at two scientific conferences in November – the World ADC Conference in San Diego, California, and PEGS Europe, in Lisbon....Preclinical findings show robust efficacy and a favorable safety profile, reinforcing best-in-class therapeutic potential."

Preclinical • Gastrointestinal Cancer

SOTIO Reports Promising Preclinical Data on Antibody-Drug Conjugates SOT109 and SOT106, Underscoring Best-in-Class Potential for Solid Tumor Treatments (Businesswire) - "SOT109...currently in IND-enabling stage with IND filing anticipated in 2026...SOT109 exhibited potent efficacy, producing significant and sustained tumor regressions in several in vivo colorectal tumor models, including cell-derived and patient-derived xenografts; The doses tested in these studies were well tolerated in mice, with no dose-limiting toxicities observed. Subsequent studies in non-human primates confirmed a favorable pharmacokinetic and safety profile....SOT106 demonstrated exceptional efficacy in an LRRC15 low-expressing patient-derived xenograft model of pediatric osteosarcoma...Complete responses and potent antitumor efficacy were also observed across a range of other models where LRRC15 is expressed directly on tumor cells, including multiple subtypes of soft tissue sarcoma, a therapy-resistant non-small-cell lung cancer model, and head and neck squamous cell carcinoma."

IND • Preclinical • Colorectal Cancer • Non Small Cell Lung Cancer • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Squamous Cell Carcinoma of Head and Neck

SOTIO to Present Preclinical Data on Lead Antibody-Drug Conjugates, SOT106 and SOT109, at 2025 AACR Annual Meeting (Businesswire) - "SOT106 is being developed for the treatment of patients with sarcomas and other LRRC15-positive tumors. The oral presentation at AACR will feature new preclinical in vitro and in vivo data....SOT109 is being developed for the treatment of colorectal cancer and other gastrointestinal cancers....The poster presentation at AACR will showcase preclinical data on the efficacy and safety of SOT109 across various models."

Preclinical • Colorectal Cancer • Sarcoma

SOTIO Unveils Promising Preclinical Data on SOT109, a Next-Gen ADC Targeting Cadherin-17 (CDH17) for Colorectal Cancer (Businesswire) - "The findings were presented at the 15th World ADC London 2025, taking place from March 3 to 6....In preclinical studies presented at World ADC London, SOT109 exhibited strong anti-tumor activity across multiple mouse xenograft models, including complete responses. It demonstrated favorable tolerability in an exploratory mouse study at doses up to 150 mg/kg. Furthermore, data from a subsequent toxicity study in non-human primates (NHPs) revealed that SOT109 displays a favorable therapeutic index underscoring its potential as a transformative therapy for GI cancers....'We look forward to filing an Investigational New Drug (IND) application for this program in Q2 2026'."

IND • Preclinical • Colorectal Cancer

SOTIO Advances Colorectal Cancer ADC Program, SOT109, and Licenses Fully Human Antibodies from Biocytogen for Novel Tumor Target (Businesswire) - "SOTIO Biotech...announced the licensing of fully human antibodies from Biocytogen....The license will be used to develop an innovative antibody drug conjugate (ADC) for a novel tumor target under the option and license agreement established between the companies. The antibody selected will support the development of SOT109....SOTIO’s ADC technology is designed to address the limitations of current ADCs, including improvement of precision targeting and overcoming tumor heterogeneity. SOT109, the newest program emerging from SOTIO’s ADC portfolio, is now at the clinical candidate selection stage, targeted against an undisclosed tumor antigen that is highly and homogeneously expressed in more than 90% of colorectal cancers....'We are now in the final stages of clinical candidate selection for the program, and plan to commence IND-enabling studies this month'."

Licensing / partnership • Preclinical • Colorectal Cancer