	US 11,883,531 B2
	Pharmaceutical compositions of IL-2
Jérémie Mariau, Fontenay sous Bois (FR); and Michel Thiry, Trooz (BE)
Assigned to ILTOO PHARMA, Paris (FR)
Filed by ILTOO PHARMA, Paris (FR)
Filed on Jul. 13, 2020, as Appl. No. 16/926,881.
Application 16/926,881 is a continuation of application No. 15/770,066, granted, now 10,722,460, previously published as PCT/EP2016/075204, filed on Oct. 20, 2016.
Claims priority of application No. 15306696 (EP), filed on Oct. 22, 2015.
Prior Publication US 2021/0128465 A1, May 6, 2021
Int. Cl. A61K 38/20 (2006.01); A61K 9/19 (2006.01); A61K 9/08 (2006.01); A61K 9/00 (2006.01); A61K 47/20 (2006.01); A61K 47/00 (2006.01); A61K 47/02 (2006.01); A61J 1/05 (2006.01)

CPC A61K 9/08 (2013.01) [A61K 9/0019 (2013.01); A61K 9/19 (2013.01); A61K 38/2013 (2013.01); A61K 47/00 (2013.01); A61K 47/02 (2013.01); A61K 47/20 (2013.01); A61J 1/05 (2013.01)]

16 Claims

1. A delivery system, comprising a device for subcutaneous injection, wherein the device is filled with an aqueous liquid pharmaceutical composition wherein the aqueous liquid pharmaceutical composition has a pH from 7.0 to 8.0 and comprises: (i) a non-lyophilized interleukin-2 (IL-2) having a specific activity of 8 to 18 MIU/mg of protein, which is present at a concentration of 0.1 to 20 million IU/mL (MIU/mL), (ii) a buffering agent at a concentration from 1 mM to 100 mM, and (iii) an anionic surfactant at a concentration from 0.01 to 5 mg/mL;

wherein the buffering agent is selected from the group consisting of phosphoric acid, Tris(hydroxymethyl) aminomethane hydrochloride (TRIS-HCl), TRIS-glycine, citrate, borate, citrate phosphate, bicarbonate, glutaric acid, succinic acid, salts thereof, and a combination thereof; and

wherein the anionic surfactant is selected from the group consisting of C₈-C₂₀alkylsulfate salts, lauroyl sarcosinate salts, cholate salts, deoxycholate salts, and a combination thereof.