SOT106 / Sotio, LigaChem Biosci - LARVOL DELTA

SOTIO Advances SOT106 with Dual FDA Designations, Further Positioning the Program as a Potential Best-in-Class ADC for Sarcoma (GlobeNewswire) - "Fast Track Designation granted for treatment of osteosarcoma; Orphan Drug Designation granted for treatment of soft tissue sarcoma....SOTIO expects to initiate a first-in-human clinical trial of SOT106 later this year."

Fast track • First-in-human • New trial • Orphan drug • Osteosarcoma • Soft Tissue Sarcoma

FDA Grants Fast Track Designation to SOTIO’s SOT106 ADC for Soft Tissue Sarcoma Treatment, Accelerating Clinical Development (The Manila Times) - "First-in-human study expected to begin this year, marking a key development milestone for SOT106."

Fast track • First-in-human • New trial • Soft Tissue Sarcoma

A Study to Assess Safety and Efficacy of SOT106 in Patients With LRRC15-positive Advanced Unresectable or Metastatic Osteosarcoma or Soft Tissue Sarcoma (clinicaltrials.gov) - P1/2 | N=70 | Not yet recruiting | Sponsor: SOTIO Biotech a.s.

First-in-human • New P1/2 trial • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • LRRC1

LigaChem ADC Research Head Chung Chul-woong: “Four next-generation ADCs to enter Phase 1 this year” (BioNews) - "In particular, the gastric cancer-targeted ADC 'LCB02A (Claudin 18.2 ADC),' expected to be administered to its first patient in the third quarter of this year...'LCB97 received IND approval from the Japanese regulatory authorities as planned, and we are currently preparing for a global IND submission.'...'An IND submission for SOT106 is planned for H2 2026.'"

IND • Trial status • Gastric Cancer • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma

SOTIO Receives U.S. FDA Orphan Drug Designation for SOT106, a Potential Best-in-Class ADC for Sarcoma (The Manila Times) - "SOTIO expects to initiate a first-in-human clinical trial of SOT106 in the second half of 2026."

Orphan drug • Soft Tissue Sarcoma

SOT106, a novel best-in-class antibody-drug conjugate targeting LRRC15, to treat sarcomas and other advanced solid cancers (AACR 2025) - "Dose-limiting toxicities were consistent with the known MMAE-mediated effects. In parallel, we have also developed a highly specific proprietary diagnostic antibody to be used for prospective patient selection in Phase I/Phase II clinical trial.In summary, SOT106 is a highly effective and well-tolerated LRRC15 targeted ADC that holds promise for the clinical treatment of patients with sarcomas and other LRRC15-positive tumors."

ADC • Metastases • Brain Cancer • Breast Cancer • CNS Tumor • Glioblastoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CAFs • LRRC1

Ligachem wins milestone as SOTIO advances ADC SOT106 toward global IND (Chosun Biz) - "LigaChem Biosciences said on the 9th that it is set to receive a milestone payment (a technology fee tied to development stages) from its global partner SOTIO Biotech under their Antib....The milestone reflects development progress for SOT106, an LRRC15-targeting ADC candidate SOTIO is developing for sarcoma and other solid tumors. SOT106 aims to treat sarcoma and LRRC15-positive solid tumors....Under the agreement, LigaChem Biosciences secured the right to receive up to $1.0275 billion (about 1.5 trillion won) in milestones across development and approval stages, plus royalties linked to sales (a portion of sales revenue)."

Financing • Sarcoma

TARGETING LEUCINE-RICH REPEAT-CONTAINING PROTEIN 15 (LRRC15): SOT106 ANTIBODY-DRUG CONJUGATE FOR SOFT TISSUE SARCOMA AND OSTEOSARCOMA TREATMENT (CTOS 2025) - "SOT106 is a highly effective and well-tolerated LRRC15-targeted ADC with significant promise for treating sarcomas and potentially other LRRC15-positive malignancies. Its preclinical profile supports further clinical development."

Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • LRRC1

SOTIO Biotech…announced favorable preclinical results supporting the development of SOT106, its antibody-drug conjugate for the treatment of sarcoma, at the Connective Tissue Oncology Society (CTOS) Annual Meeting… (Businesswire) - "In vivo, SOT106 drives dose-dependent tumor regression, including complete responses at 1 mg/kg, and surpasses benchmarks in both soft tissue sarcoma and osteosarcoma patient-derived xenograft (PDX) models, including those with low-to-medium LRRC15 expression and in orthotopic osteosarcoma....SOTIO is advancing SOT106 through IND-enabling studies toward an anticipated IND filing in Q4 2026."

IND • Preclinical • Osteosarcoma • Soft Tissue Sarcoma

SOT106, a novel ADC targeting LRRC15 for the treatment of mesenchymal tumors… (Businesswire) - "SOTIO Biotech...announced it will present new preclinical...data...[at] the World ADC Conference....Preclinical data demonstrate a high therapeutic index and strong anti-tumor activity, supporting its potential best-in-class profile."

Preclinical • Solid Tumor

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

Ligachem Bio Strengthens Global Position with Preclinical Results of LCB39 and ADC Candidates [Google translation] (Nate) - "Biotechnology company Ligachem Biosciences will present the results of a total of five preclinical studies, including the next-generation immunotherapy STING agonist 'LCB39', at the '2025 American Association for Cancer Research (AACR)' held in Chicago, USA from the 25th to the 30th....This presentation includes oral and poster presentations on candidates such as LCB39, an immune-oncology drug candidate independently developed by Ligachembio, as well as SOT106 (LRRC15 ADC) and IKS04 (CA242 ADC), which were derived through the transfer of antibody-drug conjugate (ADC) platform technology."

Preclinical • Oncology

Targeting leucine-rich repeat-containing protein 15 (LRRC15): SOT106 antibody-drug conjugate for soft tissue sarcoma and osteosarcoma therapy (Sarcoma-RC 2025) - "Combined with its superior performance over clinical benchmark, these results underscore the potential of SOT106 as a best-in-class targeted treatment for these challenging malignancies. Legal entity responsible for the study SOTIO Biotech a.s."

Leiomyosarcoma • Oncology • Osteosarcoma • Pediatrics • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • LRRC1

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 Exercises Option for Novel Antibody-Drug Conjugate Program under Agreement with LegoChem Biosciences (GlobeNewswire) - "SOTIO Biotech...today announced that is has exercised its first of five exclusive, target-specific options with LegoChem Biosciences...for antibody-drug conjugate (ADC) SOT106, which is currently being evaluated in preclinical studies across a multitude of solid tumor indications....We look forward to further achieving progress in our efficient and close partnership as this effort continues into generating new drug candidates."

Licensing / partnership • Oncology • Solid Tumor