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huMNC2-scFv-CAR T is an autologous chimeric antigen receptor (CAR) T-cell therapy developed by Minerva Biotechnologies that targets MUC1* (muk 1 star), the tumor-associated, cleaved growth factor receptor form of mucin-1 (MUC1). Unlike full-length MUC1, which is widely expressed on normal epithelial tissues, MUC1* is a transmembrane cleavage product that is selectively overexpressed on approximately 75% of solid tumors, including over 90% of breast cancers. The therapy utilizes a humanized single-chain variable fragment (scFv) derived from the MNC2 antibody to specifically bind to the unmasked ectopic site of MUC1* in the tumor microenvironment. Minerva has developed multiple CAR constructs under this program, including huMNC2-CAR44 (utilizing a 4-1BB co-stimulatory domain) and huMNC2-CAR22 (utilizing a CD28 co-stimulatory domain and bearing the '1XX' mutations in the CD3ζ signaling domain to reduce T-cell exhaustion and enhance persistence). huMNC2-scFv-CAR T is currently being evaluated in clinical trials for the treatment of metastatic breast cancer and other MUC1*-positive solid tumors.
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