The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for ImmixBio’s IMX-110 for the treatment of a form of pediatric cancer in children. The cancer, rhabdomyosarcoma (RMS), is a malignant neoplasm and a very common sarcoma within pediatric and adolescent populations. RMS rarely occurs in adults and prevalence of the sarcoma in the U.S. is estimated to be 20,000 children. IMX-110 is a tissue-specific therapeutic that works to attack components of the tumor microenvironment, effectively disabling the metabolic and structural support of the tumor. Previously, the FDA granted IMX-110 orphan drug designation (ODD) for the treatment of soft tissue sarcoma. In the case of serious and life-threatening diseases that affect children and impact fewer than 200,000 people, the FDA can grant RPD designation. ImmixBio is a clinical-stage biopharmaceutical company that develops tissue-specific therapeutics to target oncological and immuno-dysregulated diseases.

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