SL Science licensor files FDA drug master file for GDT exosomes

SL Science Holding Limited (NASDAQ: SLBT) announced that JY BioMed Co., Ltd., its licensor and the intellectual property holder of the Gamma Delta T (GDT) platform, has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration under number 044612, covering exosomes derived from GDT cells.

The filing adds to an existing DMF for GDT cells themselves, placing chemistry, manufacturing, and controls documentation on file with the FDA for both the cells and the cell-free exosomes those cells produce. A DMF does not constitute FDA approval of any product; it provides the agency with confidential manufacturing and quality data that can be referenced in future regulatory applications.

According to the company, published preclinical research indicates that GDT-derived exosomes carry proteins associated with triggering tumor cell death and stimulating immune responses. Independent studies cited by the company suggest the exosomes may work alongside radiotherapy and remain active in immunosuppressive tumor environments. All findings referenced are preclinical and do not establish clinical safety or efficacy.

SL Science noted that the exosome format may be relevant to its brain cancer program. Independent studies have shown that extracellular vesicles such as exosomes can cross the blood-brain barrier through a receptor-mediated biological route, a characteristic that larger cells do not share.

"There is now manufacturing and quality documentation on file with the FDA for both the GDT cells and the exosomes those cells secrete — work no downstream program has to do again," said William Wang, Chairman and Chief Executive Officer of SL Science.

SL Science is a Taiwan-based biomedical company focused on cellular and gene therapies. Its product candidates remain preclinical, and no candidate has received regulatory approval.

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