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DALNACOGÉN PONPARVOVEC
RECOMBINANT, SELF-COMPLEMENTARY, NON-REPLICATING ADENOASSOCIATED VIRUS, SYNTHETIC LIVER-TROPIC SEROTYPE 843 (RAAV843) VECTOR, ENCODING A CODON-OPTIMISED (CPG REDUCED) GAIN OF FUNCTION VARIANT (PADUA VARIANT; R338L) OF HUMAN COAGULATION FACTOR IX (FIX), UNDER CONTROL OF A SYNTHETIC LIVER-SPECIFIC LXP2.1 PROMOTER AND A SYNTHETIC POLYADENYLATION (POLYA) SEQUENCE DERIVED FROM THE RABBIT BETA-GLOBIN GENE POLYA SIGNAL. THE EXPRESSION CASSETTE ALSO CONTAINS A HUMAN DNA-DEPENDENT RNA POLYMERASE II GENE INTRON, A KOZAK SEQUENCE, A HUMAN IMMUNOGLOBULIN HEAVY CHAIN VARIABLE REGION GENE INTRON INSERTED INTO THE MIDDLE OF THE FIX CODING REGION, AND AN ENHANCER DERIVED FROM THE PROMOTER REGION OF HUMAN ALPHA-1-ANTITRYPSIN. THE TRANSGENE IS FLANKED BY ADENOASSOCIATED VIRUS 2 (AAV2) INVERTED TERMINAL REPEATS (ITRS)