SL Science files FDA orphan drug request for GDT glioblastoma therapy

SL Science Holding Limited (Nasdaq: SLBT), a Taiwan-based biomedical company, has submitted an Orphan Drug Designation (ODD) request to the U.S. Food and Drug Administration for its Gamma Delta T cell therapy product, Vdelta2+ Gamma Delta T Cells, targeting glioblastoma multiforme (GBM).

The FDA's Office of Orphan Products Development acknowledged receipt of the request, assigned designation request number DRU-2026-11528, and is proceeding with review. The request was received March 30, 2026, and was submitted under Section 526 of the Federal Food, Drug, and Cosmetic Act.

The ODD program applies to therapies targeting diseases affecting fewer than 200,000 patients annually in the United States. Glioblastoma multiforme is a form of primary brain cancer with a median survival of approximately 15 months under current standard of care.

SL Science licenses its GDT cell therapy technology from JY BioMed, the intellectual property holder of the platform. The company says the therapy targets tumor cells independent of major histocompatibility complex presentation, which it describes as a mechanism distinct from conventional T cell therapies.

JY BioMed's research team is scheduled to present findings on the GBM treatment asset at the 20th World Congress of Basic and Clinical Pharmacology, held July 12–17, 2026, in Melbourne, Australia. The presentation is titled "Intracranial γδ T Cell Therapy Eliminates Glioblastoma in Preclinical Models."

"Submitting the ODD is a critical step forward in our strategy to accelerate the clinical development of our GDT cell platform," said William Wang, Chairman and Chief Executive Officer of SL Science.

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