The US Food and Drug Administration (FDA) has granted clearance to Plus Therapeutics' Investigational New Drug (IND) application for Reyobiq (Rhenium Re186 Obisbemeda), a new radiotherapy to treat high-grade glioma (HGG) and ependymoma in children.
Reyobiq’s targeted approach delivers concentrated radiation doses directly into central nervous system tumours. Credit: National Cancer Institute/Unsplash.
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Paediatric HGG, including ependymoma, are not only rare but also very difficult to treat, with current standard care failing to prevent recurrence and with five-year survival rates.
Reyobiq is designed to use convection enhanced delivery (CED) for its targeted transport and to bypass the blood-brain barrier directly targeting tumour cells which may improve patient outcomes.
Its targeted approach delivers concentrated radiation doses directly into central nervous system (CNS) tumours.
Reyobiq formulation leverages Rhenium-186, an isotope selected for its short half-life and dual energy capabilities.
Plus Therapeutics president and CEO Marc Hedrick said: “This paediatric FDA clearance builds on our successful track record in the safe administration and promising efficacy signals observed in adult patients with more common central nervous cancers.
“We expect Reyobiq will offer much needed hope to children with aggressive and difficult-to-treat brain cancers and their families.”
The therapy aims at enhancing safety while reducing risks associated with off-target effects common in existing therapies.
It is under evaluation at present in clinical trials ReSPECT-GBM for recurrent glioblastoma and ReSPECT-LM for leptomeningeal metastases.
Furthermore, the ReSPECT-PBC (paediatric brain cancer) trial is based upon preclinical data along with clinical results already observed in adult recurrent glioblastoma trial (ReSPECT-GBM).
The company combines image-guided local beta radiation and targeted drug delivery approaches to advance a pipeline of product candidates.
