SOTIO Advances SOT106 with Dual FDA Designations, Further Positioning the Program as a Potential Best-in-Class ADC for Sarcoma

• Fast Track Designation granted for treatment of osteosarcoma
• Orphan Drug Designation granted for treatment of soft tissue sarcoma
• Multiple FDA designations underscores the promise of SOT106 and strengthens the program’s potential path to patients
• First-in-human study of SOT106 on track to be initiated in 2026
  

PRAGUE and BASEL, Switzerland and BOSTON, Sept. 23, 2026 (GLOBE NEWSWIRE) -- SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, today announced that the U.S. Food and Drug Administration has granted SOT106 Orphan Drug Designation for the treatment of soft tissue sarcoma (STS) and Fast Track Designation for the treatment of osteosarcoma, supporting its planned clinical development as a potentially best-in-class investigational antibody-drug conjugate (ADC) across multiple sarcoma subtypes.

With these additions, SOT106 has now received both Orphan Drug and Fast Track Designations for osteosarcoma and STS. Its potential across these indications is rooted in selective binding to leucine-rich repeat-containing 15 (LRRC15), a clinically validated target broadly expressed across multiple highly prevalent sarcoma subtypes. Preclinical data, including patient-derived xenograft models of both osteosarcoma and STS, indicate that SOT106 is potent and well-tolerated, with a high therapeutic index and strong anti-tumor activity.

“These additional designations mark another important milestone for SOT106 and reflect the growing momentum behind our ADC portfolio,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “Patients with sarcoma continue to face limited treatment options, underscoring the need for innovative targeted therapies. As we advance SOT106 toward the clinic, we believe it has the potential to become an important treatment option for patients in need.”

SOT106 combines SOTIO’s proprietary LRRC15-targeting antibody with LigaChem Biosciences’ ConjuAll™ site-specific conjugation and beta-glucuronidase-cleavable linker, which is designed to remain stable in circulation and release the payload selectively within the tumor.

Fast Track Designation (FTD) and Orphan Drug Designation (ODD) are intended to support the development of promising therapies for rare diseases and areas of high unmet need, providing opportunities for enhanced regulatory engagement and other incentives that may help accelerated development.

SOTIO expects to initiate a first-in-human clinical trial of SOT106 later this year.

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, currently in a Phase 1/2 study for colorectal cancer, has received Fast Track Designation (FTD) from the U.S. FDA. SOT106, targeting LRRC15 for sarcoma and other solid tumors, has received both Orphan Drug Designation (ODD) and FTD from the U.S. FDA.

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.