OliX partner SOTIO's SOT106 receives U.S. FDA Fast Track designation

[Financial News] SOTIO Biotech, a partner of OliX, said its antibody-drug conjugate (ADC) candidate SOT106 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue sarcoma.
The company plans to begin a clinical trial with its first patient this year, raising expectations that clinical development of new drug candidates using OliX's ADC platform technology will also accelerate.
OliX said on the 27th that SOTIO's SOT106 (LRRC15-ADC) had received Fast Track designation from the FDA for the treatment of soft tissue sarcoma.
SOT106 is a candidate that combines SOTIO's LRRC15-targeting antibody with OliX's next-generation ADC platform, ConjuALL.
LRRC15 is a target broadly expressed across multiple sarcoma subtypes, and SOT106 is being developed as a potential new treatment option for patients with soft tissue sarcoma, who have limited therapeutic choices.
The FDA's Fast Track program is designed to speed up the development and review of drugs for serious diseases with high unmet medical needs, where existing treatments are not expected to provide sufficient benefit.
With Fast Track designation, companies can consult with the FDA more frequently during development. If requirements are met, they may also be able to use processes such as Rolling Review and Priority Review.
SOT106 had already received Orphan Drug Designation (ODD) from the FDA in May for the treatment of osteosarcoma. With the addition of Fast Track designation for soft tissue sarcoma, its development potential in the sarcoma field is drawing more attention.
SOTIO plans to begin its first-in-human clinical trial of SOT106 this year.
The latest milestone also carries significance for the partnership between OliX and SOTIO. The two companies signed an ADC platform technology transfer agreement in November 2021, through which SOTIO secured global development and commercialization rights for multi-target ADC therapeutics using OliX's ConjuALL.
SOT106 is the first ADC candidate derived from that agreement. Its clinical results are expected to serve as an important benchmark for the global scalability and commercialization potential of OliX's ADC platform technology.
Vibhav Bora, chief medical officer at SOTIO, said, "This Fast Track designation is an important regulatory milestone that supports the differentiated design of SOT106 and the potential of its LRRC15-targeting strategy to offer new treatment options for patients across multiple soft tissue sarcoma subtypes."

[email protected] Kang Jung-mo Reporter