FDA Grants Fast Track Designation to SOTIO’s SOT106 ADC for Soft Tissue Sarcoma Treatment, Accelerating Clinical Development
SOT106 targets LRRC15, a clinically validated target broadly expressed across multiple sarcoma subtypes First-in-human
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- SOT106 targets LRRC15, a clinically validated target broadly expressed across multiple sarcoma subtypes
- First-in-human study expected to begin this year, marking a key development milestone for SOT106
PRAGUE, Basel and BOSTON, Aug. 26, 2026 (GLOBE NEWSWIRE) —
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 (FTD) to SOT106, the company’s potentially best-in-class investigational antibody-drug conjugate (ADC), for the treatment of soft tissue sarcoma, underscoring the urgency of developing new treatment options and the potential of SOT106 to address a significant unmet medical need.
SOT106 targets leucine-rich repeat-containing 15 (LRRC15), a clinically validated target broadly expressed across multiple highly prevalent sarcoma subtypes, positioning it to potentially address a broad population of patients with limited therapeutic options.
“Soft tissue sarcomas (STS) remain a major unmet medical need, where decades of therapeutic progress have yet to translate into meaningful improvements for patients with advanced or recurrent disease,” said Vivi Boura, M.D., chief medical officer of SOTIO. “Receiving Fast Track Designation for SOT106 is an important regulatory milestone that reinforces this program’s potential to improve outcomes for patients facing these difficult-to-treat cancers. As we advance SOT106 toward the clinic, we aim to translate its differentiated design and LRRC15-targeting strategy into a novel therapeutic approach with the potential to offer a new treatment option for patients across multiple soft tissue sarcoma subtypes.”
Fast Track Designation is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs. The designation provides opportunities for more frequent interactions with the FDA and may support an accelerated pathway through eligibility for rolling review and Priority Review, if applicable criteria are met.
SOT106 has also received FDA Orphan Drug Designation for the treatment of osteosarcoma, further highlighting its potential across high-need sarcoma indications. SOTIO expects to initiate a first-in-human clinical trial later this year, marking the next key milestone in clinical development of SOT106.
| Company contact:
Richard Kapsa |
Media contact:
Lisa Raffensperger Ten Bridge Communications M: +1 (617) 575-2647 lisa@tenbridgecommunications.com |
About SOTIO Biotech
SOTIO Biotech (SOTIO) is a clinical-stage biopharmaceutical company advancing a focused pipeline of next-generation antibody-drug conjugates (ADCs) for solid tumors. The company is pursuing targeted therapies for cancers with significant unmet need and broad expansion potential.
SOTIO’s two lead ADC programs, SOT106 and SOT109, are potential best-in-class therapies designed to rapidly advance to clinical proof of concept. SOT109, targeting CDH17 for the treatment of colorectal cancer, received Fast Track Designation (FTD) from the U.S. FDA in July 2026. SOT106, targeting LRRC15 for sarcoma and other solid tumors, is in preclinical development and received Orphan Drug Designation (ODD) from the U.S. FDA in May 2026.
The broader pipeline also includes SOT201, a next-generation PD-1-targeting immunocytokine, currently being evaluated in the Phase 1 VICTORIA-01 study in patients with solid tumors. SOTIO is a member of the PPF Group. For more information, please visit the company’s website at www.sotio.com.
SOTIO is a registered trademark of SOTIO Biotech a.s. in selected countries.
