[Edaily Reporter NA EUN-KYUNG ] SOTIO Biotech, a partner company of LigaChem Biosciences(141080), announced on the 27th that SOT106, an antibody-drug conjugate (ADC) currently under development, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue sarcoma.

LigaChem Biosciences announced on the 27th that SOTIO had received FDA Fast Track designation for SOT106. SOT106 is a candidate drug created by applying LigaChem Biosciences’s next-generation ADC platform, “ConjuAll,” to SOTIO’s LRRC15-targeting antibody.

Fast Track is an FDA program designed to expedite the development and review of therapies that have the potential to address unmet medical needs for serious diseases. Designated candidates can engage in more frequent consultations with the FDA during the development process and, if they meet the relevant requirements, may be eligible for benefits such as Rolling Review—where application materials are submitted as they are completed—and Priority Review.

SOT106 is an antibody-drug conjugate that targets leucine-rich repeat-containing protein 15 (LRRC15). LRRC15 is a protein expressed in several subtypes of soft tissue sarcoma, and SOTIO is developing SOT106 for patients with soft tissue sarcoma who have limited treatment options.

Soft tissue sarcoma is a general term for malignant tumors that originate in soft tissues such as muscles, fat, blood vessels, and nerves. It is divided into various histological subtypes, and because treatment options are limited for patients with advanced or recurrent disease, there is a high demand for the development of new therapies in this field.

SOT106 was also designated as an FDA Orphan Drug for the treatment of osteosarcoma last May. Following this Orphan Drug designation, it received Fast Track designation for soft tissue sarcoma, enabling the company to leverage regulatory support from the FDA during the development process for the sarcoma indication. SOTIO plans to begin the first-in-human clinical trial of SOT106 within this year.

SOT106 is the first candidate compound to emerge from the antibody-drug conjugate (ADC) platform technology transfer agreement signed between LigaChem Biosciences and SOTIO in November 2021. At that time, SOTIO secured global development and commercialization rights for multi-target ADCs utilizing LigaChem Biosciences’ Conjuol platform.

Vivi Boura, Chief Medical Officer (CMO) of SOTIO, stated, “Soft tissue sarcoma is a prime example of an area with unmet medical needs where, despite decades of drug development, there is still a need to improve treatment outcomes for patients with advanced or recurrent disease,” and “Building on this Fast Track designation, we will advance the clinical development of SOT106 to confirm its potential to provide new treatment options for patients with various subtypes of soft tissue sarcoma,” she said.