LigaChem Biosciences(141080)'s Antibody-Drug Conjugate (ADC) new drug candidate, which was licensed out to U.S.-based Sotio Biotech, was designated for fast-track development by the U.S. Food and Drug Administration (FDA).
Fast track is an FDA program to expedite the development and review of new drugs for patients with serious conditions where existing treatments are inadequate. Once designated, sponsors can consult more frequently with the FDA during development and, if requirements are met, can receive rolling review for stepwise submission of application materials or priority review.
LigaChem Biosciences said on the 27th that partner Sotio's "SOT106 (LRRC15-ADC)" was designated for fast track for the treatment of soft tissue sarcoma.
SOT106 is a candidate that combines Sotio's LRRC15-targeting antibody with LigaChem Biosciences' ADC platform "ConjuAll." LRRC15 is a target known to be expressed in several sarcoma subtypes.
SOT106 earlier received orphan drug designation (ODD) from the FDA in May for the treatment of osteosarcoma. Sotio plans to begin the first-in-patient clinical trial of SOT106 within the year.