Stable anti-clever-1 antibody formulation
The invention relates to stable formulations comprising an anti-CLEVER-1 antibody or antigen binding fragment(s) thereof, a buffer and a stabilizing agent. The present invention further relates to stable formulations of an anti-CLEVER-1 antibody or antigen binding fragments thereof for use in treatment of various diseases and disorders.
1 . A stable pharmaceutical formulation, which comprises
1-100 mg/ml of an anti-CLEVER-1 antibody or antigen binding fragment(s) thereof,
5-50 mM of a histidine buffer in combination with 150 mM-400 mM of a trehalose as a stabilizing agent, wherein the pH of said pharmaceutical formulation is in the range of 5.5-6.5, and
0.01-0.1% (w/v) of polysorbate as a non-ionic surfactant,
wherein the anti-CLEVER-1 antibody or antigen binding fragment(s) thereof comprises the amino acid sequence SEQ ID NO: 7 of a heavy chain and the amino acid sequence SEQ ID NO: 8 of a light chain.
2 . The formulation according to claim 1 , wherein the anti-CLEVER-1 antibody is bexmarilimab or bexmarilimab variant or the antibody in a bexmarilimab biosimilar.
3 . The formulation according to claim 1 , wherein the anti-CLEVER-1 antibody is antibody FP-1305 (DSM ACC3361).
4 . The formulation according to claim 1 , wherein the formulation comprises histidine buffer and has a pH between 5.8 and 6.2.
5 . The formulation according to claim 1 , wherein the histidine buffer comprises L-histidine.
6 . The formulation according to claim 1 , wherein the formulation comprises 5-20 mM or 5-15 mM of the histidine buffer.
7 . The formulation according to claim 1 , wherein the formulation comprises 200-360 mM of trehalose as a stabilizing agent.
8 . The formulation according to claim 1 , wherein the formulation comprises polysorbate 20 as a non-ionic surfactant.
9 . The formulation according to claim 8 , wherein the formulation comprises 10-100 mg/ml of an anti-CLEVER-1 antibody or antigen binding fragment(s) thereof.
10 . The formulation according to claim 1 , wherein the formulation comprises 0.01-0.05% (w/v) of polysorbate.
11 . The formulation according to claim 1 , wherein the composition further comprises an antioxidant.
12 . The formulation according to claim 1 , wherein the formulation comprises:
(i) 1-100 mg/ml of an anti-CLEVER-1 antibody or antigen binding fragment(s) thereof,
(ii) 5-50 mM of histidine buffer,
(iii) 150-400 mM of trehalose as the stabilizing agent,
(iv) 0.01-0.1% (w/v) of polysorbate as the non-ionic surfactant, and
(v) 5-40 mM of L-methionine as the antioxidant,
wherein the pH of said composition is between 5.5 and 6.5.
13 . The formulation according to claim 1 , wherein the formulation is a liquid formulation or in a lyophilized form.
14 . The formulation according to claim 1 , wherein the formulation comprises 240-320 mM of trehalose as a stabilizing agent.
15 . The formulation according to claim 1 , wherein the formulation comprises 270-290 mM of trehalose as a stabilizing agent.
16 . The formulation according to claim 10 , wherein the formulation comprises 0.01-0.05% (w/v) of polysorbate 20.
17 . The formulation according to claim 11 , wherein the antioxidant comprises L-methionine.
18 . The formulation according to claim 17 , wherein the composition comprises 5-40 mM of L-methionine.
19 . The formulation according to claim 17 , wherein the composition comprises 15-25 mM of L-methionine.