SL Science Holding Limited (SLBT), a biomedical company, on Friday announced the submission of an Orphan Drug Designation (ODD) request to the U.S. Food and Drug Administration (FDA) for the VDelta2+ Gamma Delta T (GDT) cell therapy for treating glioblastoma multiforme (GBM).
ODD is granted by the FDA to therapies targeting diseases affecting fewer than 200,000 patients in the United States annually.
The GDT technology allows for the recognition and targeting of tumor cells with no presentation of the major histocompatibility complex (MHC) antigens on their surface. The VDelta2+ GDT therapy was licensed from JY BioMed.
The Office of Orphan Products Development (OOPD) at the FDA acknowledged receipt of the application and is currently reviewing additional files in relation to the submission.
SLBT is currently trading up 9.86% at $5.00.
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