US 11,730,812 B2
Anti-IL-36R antibody formulations
Sandra Nicole Denkinger, Biberach an der Riss (DE); Anna Maria Steiner, Eberhardzell (DE); Derrick Spencer Katayama, Timnath, CO (US); Rajni Prasad Mehra, Pleasanton, CA (US); Ingo Michael Presser, Biberach an der Riss (DE); Ravija Singh, Fremont, CA (US); and Sara Kay Wright, Castro Valley, CA (US)
Assigned to Boehringer Ingelheim International GmbH, Ingelheim am Rhein (DE)
Filed by Boehringer Ingelheim International GmbH, Ingelheim am Rhein (DE)
Filed on Mar. 5, 2020, as Appl. No. 16/809,606.
Claims priority of provisional application 62/815,405, filed on Mar. 8, 2019.
Prior Publication US 2020/0282053 A1, Sep. 10, 2020
Int. Cl. A61K 39/395 (2006.01); A61K 9/00 (2006.01); A61K 9/19 (2006.01); C07K 16/24 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 47/34 (2017.01); A61K 47/14 (2017.01)
CPC A61K 39/39591 (2013.01) [A61K 9/0019 (2013.01); A61K 9/19 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); C07K 16/244 (2013.01); A61K 47/14 (2013.01); A61K 47/34 (2013.01); C07K 2317/565 (2013.01)] 40 Claims
 
1. An antibody formulation comprising:
(a) an anti-Interleukin-36 receptor (anti-IL-36R) antibody or an antigen binding fragment thereof present at a concentration within the range from about 10 mg/mL to about 200 mg/mL;
(b) an acetate buffer present at a concentration of about 45 mM;
(c) sucrose present at a concentration of about 150 mM;
(d) L-arginine or a pharmaceutically acceptable salt thereof present at a concentration of about 25 mM; and
(e) polysorbate 20 present at a concentration of about 0.4 g/L;
wherein the formulation in liquid form or when reconstituted with water is characterized by a pH within the range from about 5 to about 6; and
further wherein the anti-IL-36R antibody or an antigen binding fragment thereof is selected from the following:
(i) an antibody or an antigen binding fragment thereof comprising a light chain variable region comprising the amino acid sequence of SEQ ID NO: 80; and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 87; or
(ii) an antibody or an antigen binding fragment thereof the amino acid sequence of SEQ ID NO: 80; and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 88; or
(iii) an antibody or an antigen binding fragment thereof the amino acid sequence of SEQ ID NO: 80; and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 89.