On July 10, 2026 SL Science Holding Limited ("SL Science" or the "Company") (Nasdaq: SLBT), a Taiwan-headquartered biomedical company specializing in developing innovative cellular and gene therapies, reported that the Company has submitted an Orphan Drug Designation (ODD) request to the U.S. Food and Drug Administration (FDA) for its Gamma Delta T (GDT) cell therapy product, Vdelta2+ Gamma Delta T Cells, for the treatment of glioblastoma multiforme (GBM). The FDA’s Office of Orphan Products Development (OOPD) has formally acknowledged receipt of the request and is proceeding with review on additional files about the product

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The research team of JY BioMed ("JY BioMed"), licensor of the Company’s GDT cell therapy technology will present at the 20th World Congress of Basic and Clinical Pharmacology (WCP 2026) held at July 12-17, 2026 in Melbourne, Australia. JY BioMed will present the Company’s GBM treatment asset themed by "Intracranial γδ T Cell Therapy Eliminates Glioblastoma in Preclinical Models". Representatives from SL Science will also be present at the event. WCP is among the most influential international pharmacology congresses in the world, convening leading researchers and clinical scientists from across the globe. Presenting at the event reflects the growing international recognition of GDT cell therapy as a serious candidate in solid tumor oncology.

Designation Details

The ODD request was submitted pursuant to Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb).

Product: Vdelta2+ Gamma Delta T Cells
Disease / Condition: Glioblastoma Multiforme (GBM)
Designation Request Number: DRU-2026-11528
Date of Receipt: March 30, 2026

The GDT Platform: A Differentiated Mechanism

SL Science’s GDT cell therapy platform offers a distinct immunological mechanism. Unlike conventional T cell therapies, GDT cells recognize and target tumor cells independent of major histocompatibility complex (MHC) presentation, enabling direct cancer cell engagement and overcoming the key challenges of tumor heterogeneity and immune evasion in solid tumors.

The GDT technology is licensed from JY BioMed, the intellectual property holder of the GDT platform. The submission of the ODD request for GDT cell therapy product for the treatment of GBM marks an important regulatory milestone in advancing GDT cell therapy toward clinical development in brain cancer.

Addressing a Critical Unmet Medical Need

Glioblastoma multiforme is among the most aggressive and lethal forms of primary brain cancer. Under current standard of care, median survival is around 15 months, and patients may face severely limited effective treatment options, representing one of the largest unmet medical needs in oncology.

ODD is granted by the FDA to therapies targeting diseases affecting fewer than 200,000 patients in the United States annually. ODD formally recognizes the unmet medical need and may provide regulatory support, including potential access to accelerated review pathways and related policy incentives, to help bring innovative therapies to patients more efficiently.

"Submitting the ODD is a critical step forward in our strategy to accelerate the clinical development of our GDT cell platform," said Mr. William Wang, Chairman and Chief Executive Officer of SL Science. "Glioblastoma is a devastating disease with a median survival rate of around15 months, representing a significant unmet medical need and commercial opportunity. By leveraging our platform’s unique ability to bypass the defenses solid tumors use to evade standard therapies, we believe this product candidate has the potential to redefine the immuno-oncology landscape and deliver meaningful value to both patients and our shareholders."

(Press release, SL Science, JUL 10, 2026, View Source [SID1234669147])