ANKTIVA Solution for injection Ref.[109663] Active ingredients: Nogapendekin alfa

Nogapendekin alfa inbakicept-pmln is an interleukin-15 (IL-15) receptor agonist. It is a soluble complex consisting of (a) nogapendekin alfa (a human IL-15N72D variant, 114 amino acids) bound to (b) inbakicept [a dimeric human IL-15Rα sushi domain (65 amino acids)/human IgG1 Fc fusion protein (232 amino acids)]. Each fully assembled nogapendekin alfa inbakicept-pmln complex consists of a single inbakicept and two nogapendekin alfa components. Each IL-15N72D component is bound to one of the IL-15Rα sushi domains.

The recombinant protein complex is produced by a recombinant cell line that was created by transfecting a Chinese hamster ovary (CHO-K1) cell line with plasmids carrying genes for the IL-15N72D and IL15RαSu/IgG1 Fc proteins. Purification of the product is achieved by conventional chromatography. The molecular weight of the deglycosylated nogapendekin alfa inbakicept-pmln complex is 92,106.5 Da. The molecular weights of the individual deglycosylated sub-units are 66565.6 Da (dimer) and 12,770.45 Da for the IL-15RαSu/IgG1 Fc domain and the IL-15N72D domain, respectively.

ANKTIVA (nogapendekin alfa inbakicept-pmln) solution is a clear to slightly opalescent, colorless to slightly yellow solution provided in a single-dose vial containing 400 mcg in 0.4 mL for intravesical administration upon dilution [see Dosage and Administration (2)]. Each vial also contains dibasic sodium phosphate (0.57 mg), monobasic potassium phosphate (0.54 mg), sodium chloride (3.27 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide is added to adjust the pH to 7.4.