FDA Grants Approval for Myrio's Breakthrough Neuroblastoma Treatment in Human Trials
FDA Approval for Myrio's Innovative Therapy
On May 7, 2025, the U.S. Food & Drug Administration (FDA) granted approval for an Investigational New Drug (IND) application submitted by Myrio Therapeutics. This approval allows Myrio's leading product, PHOX2B PC-CAR T, to enter human clinical trials for the treatment of neuroblastoma, a challenging pediatric cancer.
Myrio's groundbreaking therapy was developed in collaboration with one of the leading children's hospitals in Philadelphia. Under the guidance of Professor John Maris, a specific protein, PHOX2B, found in neuroblastoma cells, was pinpointed as a critical target. Their research demonstrated that a peptide derived from PHOX2B could effectively serve as a target for an immunotherapy approach, aiming to combat this devastating disease, which accounts for 15% of pediatric cancer-related deaths.
Myrio has utilized its proprietary ReDTM technology to craft a highly specific binder that targets this PHOX2B peptide when presented on major histocompatibility complex (p-HLA). Importantly, this innovation sets Myrio apart, as its binder can identify the peptide across multiple HLA allotypes, a capability referred to as
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