JY BioMed Co., Ltd., the licensor of SL Science Holding Limited’s Gamma Delta T cell platform, filed a Drug Master File (DMF) with the U.S. Food and Drug Administration covering exosomes derived from these cells.
The filing, designated DMF 044612, follows earlier submissions of manufacturing and quality documentation for the Gamma Delta T cells themselves. A DMF provides the FDA with confidential chemistry, manufacturing, and controls data that may be referenced in future regulatory applications, though the agency does not approve such files.
The exosomes represent a cell-free delivery method distinct from SL Science’s cellular therapy approach. Preclinical research cited by the company indicates that exosomes derived from Gamma Delta T cells carry proteins capable of inducing tumor cell death and stimulating immune responses. Independent studies suggest these exosomes can enhance the efficacy of radiotherapy and function within immunosuppressive tumor environments. Additional research has demonstrated that extracellular vesicles, including exosomes, can traverse the blood-brain barrier via receptor-mediated pathways, enabling potential applications in central nervous system therapies.
SL Science, listed on NASDAQ under the ticker SLBT, focuses on developing cellular and gene therapies centered on Gamma Delta T cell technologies for solid tumors, including pancreatic and brain cancers. All of the company’s product candidates remain in preclinical development, according to the filing.
William Wang, Chairman and Chief Executive Officer of SL Science, stated that manufacturing and quality documentation for both the Gamma Delta T cells and their secreted exosomes are now on file with the FDA.
