SL Science seeks FDA orphan drug status for GDT cell therapy in glioblastoma

SL Science Holding Limited announced on July 10, 2026 that it had submitted an Orphan Drug Designation request to the U.S. Food and Drug Administration for its Gamma Delta T cell therapy product, Vdelta2+ Gamma Delta T Cells, for the treatment of glioblastoma multiforme.¹ The company said the FDA's Office of Orphan Products Development has formally acknowledged receipt of the request and is proceeding with review on additional files about the product.¹

The filing was made under Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb).¹ The request covers the product Vdelta2+ Gamma Delta T Cells for glioblastoma multiforme, carries designation request number DRU-2026-11528, and was received by the agency on March 30, 2026, according to the release.

SL Science described its platform's mechanism, saying that GDT cells recognize and target tumor cells independent of major histocompatibility complex presentation, enabling direct cancer cell engagement and overcoming key challenges of tumor heterogeneity and immune evasion in solid tumors, unlike conventional T cell therapies.¹ The technology is licensed from JY BioMed, the intellectual property holder of the GDT platform.¹

Separately, JY BioMed researchers are scheduled to present on the glioblastoma program at the 20th World Congress of Basic and Clinical Pharmacology held July 12-17, 2026 in Melbourne, Australia, with a presentation titled "Intracranial γδ T Cell Therapy Eliminates Glioblastoma in Preclinical Models."¹

On orphan drug status generally, the company noted that the FDA grants such designation to therapies targeting diseases affecting fewer than 200,000 patients in the United States annually.¹ The release also cited that under current standard of care, median survival for glioblastoma multiforme is around 15 months.¹