Afami-cell is a T-cell receptor (TCR) based cell therapy targeting Synovial sarcoma. TCR-based cell therapies work by engineering existing patient T-cells with new TCRs that target cancer-specific peptides presented on the surface of tumor cells. This particular therapy uses TCRs that target MAGE-A4, a protein expressed in synovial sarcomas that is largely absent from other tissues.

More broadly, TCRs have the unique ability to recognize tumor-associated mutations (neoantigens), as peptide fragments corresponding to these mutations can be presented on a cell's surface via major histocompatibility complex (MHC).

If approved, Afami-cell would be the first cell therapy approved by the FDA to treat solid tumors (many CAR-T cell therapies exist for blood cancers, but it has been hard to apply CAR-T technology to solid tumors). Aframi-cell would also the first approved TCR-based cell therapy.

More information: https://d1io3yog0oux5.cloudfront.net/_b7a8156634f9e0eb1e66f1e6f8c346b9/adaptimmune/db/249/3601/pdf/ADAP+Corporate+Deck+June+2023_FINALv.2.pdf

Adaptimmune is already in the process of applying for BLA from the FDA (latest update), after which the drug could be approved in late 2023 or 2024. This question will resolve YES if the FDA approves Afami-cel before December 31, 2024 and NO otherwise.