Ligand Pharmaceuticals' antibody-drug conjugate (ADC) candidate SOT106 has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The drug, developed by partner Sotio Biotech, is set to enter clinical trials with the first patient expected to be treated this year.
On August 27, Ligand announced that Sotio's SOT106 (LRRC15-ADC) has been granted Fast Track designation for the treatment of soft tissue sarcoma. SOT106 is a candidate that applies Ligand's next-generation ADC platform, ConjuAll, to Sotio's LRRC15-targeting antibody.
Ligand stated, "This designation confirms that SOT106 possesses best-in-class potential to address the unmet medical needs in the urgent area of soft tissue sarcoma treatment."
The LRRC15 target of SOT106 is clinically validated and is widely expressed across various subtypes of sarcoma, suggesting the potential for development in a broad patient population with limited treatment options.
Vivi Boura, Chief Medical Officer of Sotio, remarked, "Soft tissue sarcoma represents a significant unmet medical need, as treatment outcomes for progressive and recurrent patients have not meaningfully improved despite decades of development. This Fast Track designation underscores the potential of SOT106's differentiated design and LRRC15-targeting strategy to offer new treatment options for patients with various subtypes of soft tissue sarcoma."
The Fast Track program is designed to facilitate the development and review of drugs that address serious conditions and fill unmet medical needs. It provides opportunities for more frequent consultations with the FDA and supports expedited development and approval pathways, including rolling reviews and priority review if criteria are met.
Sotio plans to initiate clinical trials for SOT106 with the first patient later this year. The company intends to submit an Investigational New Drug (IND) application and Clinical Trial Application (CTA) in Moldova, where regulatory procedures are relatively swift, by the end of this month or in September, aiming for first patient dosing within the year.
Ligand entered into a technology transfer agreement with Sotio for the ADC platform in November 2021. SOT106 is the first candidate to emerge from this agreement, and the recent regulatory designation enhances the prospects for international commercialization of the technology.
Meanwhile, Ligand reported a standalone revenue of 7.1 billion won for the second quarter of this year, a 78.3% decrease compared to the same period last year. The operating loss for the same period widened to 76.4 billion won, an increase of 378.21% year-on-year.
The decline in performance is attributed to the absence of new ADC technology licensing agreements, coupled with increased investment as more projects enter clinical stages. Research and development expenses rose to 76.5 billion won, a 90% increase compared to the previous year.
* This article has been translated by AI.
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