LigaChem Biosciences’ antibody-drug conjugate (ADC) platform technology is gaining momentum in the U.S. with its drug candidate SOT106, which has secured both orphan drug and fast track designations for osteosarcoma and soft tissue sarcoma treatments.
On Monday, LigaChem Biosciences announced that its partner, Sotio Biotech, received orphan drug designation (ODD) for soft tissue sarcoma and fast track designation (FTD) for osteosarcoma from the U.S. Food and Drug Administration (FDA) for SOT106.
With these latest designations, SOT106 now holds both ODD and FTD for osteosarcoma and soft tissue sarcoma. The drug previously received ODD for osteosarcoma in May and FTD for soft tissue sarcoma in August.
SOT106 is a promising candidate that combines Sotio’s LRRC15-targeting antibody with LigaChem’s ADC platform ConjuAll™.
The drug employs site-specific conjugation technology and a beta-glucuronidase cleavable linker, designed to maintain drug stability in the bloodstream while enabling selective release of the anti-cancer agent within tumors.
LRRC15 is a protein expressed in various sarcomas, including osteosarcoma and soft tissue sarcoma. Preclinical studies, including patient-derived xenograft (PDX) models of osteosarcoma and soft tissue sarcoma, have demonstrated SOT106’s anti-tumor efficacy and tolerability.
SOT106 is the first candidate to emerge from the ADC platform technology transfer agreement between LigaChem Biosciences and Sotio in 2021. This deal could potentially net LigaChem up to 1.0275 billion USD in milestone payments throughout various stages of development, approval, and commercialization, including an upfront payment and short-term milestones totaling 29.5 million USD.
In February, SOT106 reached its first milestone payment. With the recent FDA designations and impending clinical trials, the ConjuAll platform technology is poised to make its debut in human studies.
The FDA’s fast track designation is designed to expedite the development of drugs that address serious conditions with unmet medical needs. It allows for more frequent FDA consultations and potential accelerated approval processes.
Orphan drug designation supports the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S. Benefits include tax credits during development and potential market exclusivity upon approval.
Sotio plans to initiate the first-in-human clinical trial for SOT106 by the end of this year.
Dr. Se-jin Park, Chief Executive Officer (CEO) of LigaChem Biosciences, stated that the consecutive FDA designations for SOT106 in two sarcoma indications further validate the potential of the ConjuAll platform. It’s committed to working closely with the partners to ensure a smooth transition into clinical trials.