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SL Science seeks FDA orphan status for GBM therapy
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SL Science seeks FDA orphan status for GBM therapy

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  • SL Science submitted an FDA Orphan Drug Designation request for its Vdelta2+ Gamma Delta T Cell therapy for glioblastoma.
  • The FDA acknowledged receipt of the request and is reviewing additional files.
  • SL Science said the therapy is designed to target tumor cells without relying on MHC presentation.

SL Science Holding (NASDAQ:SLBT) submitted an Orphan Drug Designation request to the U.S. Food and Drug Administration for its Vdelta2+ Gamma Delta T Cell therapy to treat glioblastoma multiforme (GBM).

The request was received by the FDA Office of Orphan Products Development on March 30, 2026, under Request No. DRU-2026-11528, as the company advances its cell therapy platform for solid tumors.

The company said the FDA has acknowledged receipt of the application and is reviewing additional files, while its licensed GDT platform from JY BioMed is being evaluated for potential use against GBM.

SL Science said JY BioMed will present preclinical GBM research titled “Intracranial γδ T Cell Therapy Eliminates Glioblastoma in Preclinical Models” at WCP 2026 in Melbourne.

SL Science develops biotechnology solutions focused on cell-based therapies and other medical technologies, including platforms targeting cancer and immune-related conditions.

The company licensed its Vdelta2+ Gamma Delta T Cell platform from JY BioMed and continues evaluating the technology through preclinical research and regulatory development activities.

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