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FDA grants Orphan Drug Designation to osteosarcoma treatment
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to a treatment for osteosarcoma.
SOT106, developed by biopharmaceutical company SOTIO Biotech, is a next-generation antibody-drug conjugate (ADC) targeting leucine-rich repeat-containing 15 (LRRC15), a clinically validated target broadly expressed across sarcoma subtypes and in tumour associated stroma.
Preclinical data has shown strong anti-tumour activity in both soft tissue and osteosarcoma models and favourable tolerability supporting a high therapeutic index.
Sarcomas are a diverse group of cancers arising in bones and soft tissues, comprising more than 70 distinct subtypes. Their rarity and biological heterogeneity have made therapeutic innovation challenging, including the development of targeted approaches such as ADCs.
Patients are primarily treated with a combination of surgery, radiation and/or chemotherapy, but outcomes remain poor for patients with aggressive, recurrent or metastatic disease. This is especially clear in osteosarcoma, the most common bone cancer in children and adolescents, where a significant number of patients require amputation of the affected limb.
“Orphan Drug Designation for SOT106 underscores both the urgent need for new treatment options in osteosarcoma and the strength of our ADC platform,” said Radek Spisek, Chief Executive Officer of SOTIO.
“Osteosarcoma is a devastating disease that has seen little therapeutic innovation over the past four decades. Treatment continues to rely on intensive chemotherapy regimens associated with significant toxicities and limited long-term benefit.
“We are encouraged by this recognition from the FDA and look forward to advancing SOT106 into the clinic later this year.”
SOTIO says it expects to initiate a first-in-human clinical trial of SOT106 in the second half of 2026.
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