Granted Patent B2

US 12,698,326 · App. 17/700,809 · Granted Aug 4, 2026

Inventors: Patrick Garidel (Ingelheim am Rhein, DE); Andreas Langer (Ingelheim am Rhein, DE); Martin Hessling (Biberach an der Riß, DE); Daniel Weinfurtner (Planegg, DE); Bodo Brocks (Planegg, DE)

Assignee: Incyte Corporation

C07K16/2803A61K9/19A61K31/715A61K47/36A61K47/549

Abstract

Claims (22)

1 . A solution comprising:

an anti-CD19 antibody in a concentration of 20 mg/ml to 125 mg/ml, wherein the anti-CD19 antibody comprises a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region comprises a HCDR1 region of sequence SYVMH (SEQ ID NO: 1), an HCDR2 region of sequence NPYNDG (SEQ ID NO:2), and an HCDR3 region of sequence GTYYYGTRVFDY (SEQ ID NO:3), and wherein the light chain variable region comprises an LCDR1 region of sequence RSSKSLQNVNGNTYLY (SEQ ID NO:4), an LCDR2 region of sequence RMSNLNS (SEQ ID NO:5), and an LCDR3 region of sequence MQHLEYPIT (SEQ ID NO:6);

a buffer;

polysorbate in a concentration of 0.005% (w/v) to 0.06% (w/v); and

a) trehalose in a concentration of 180 mM to 240 mM; or

b) mannitol in a concentration of 180 mM to 240 mM and sucrose in a concentration of 10 mM to 50 mM.

2 . The solution of claim 1 , wherein the buffer has a pH range of 5.6 to 7.0.

3 . The solution of claim 1 , wherein the buffer has a pH range of 6.

4 . The solution of claim 1 , wherein the buffer is a citrate buffer or a phosphate buffer.

5 . The solution of claim 4 , wherein the citrate buffer or the phosphate buffer is in a concentration of between 20 and 50 mM.

6 . The solution of claim 4 , wherein the citrate buffer or the phosphate buffer is in a concentration of 25 mM.

7 . The solution of claim 1 comprising trehalose in a concentration of 200 mM.

8 . The solution of claim 1 comprising mannitol in a concentration of 219 mM and sucrose in a concentration of 29 mM.

9 . The solution of claim 1 , wherein the polysorbate is polysorbate 20.

10 . The solution of claim 1 comprising polysorbate in a concentration of 0.02% (w/v).

11 . The solution of claim 1 comprising said anti-CD19 antibody in an amount of 40 mg/ml, citrate buffer in a concentration of 25 mM, trehalose in a concentration of 200 mM, and polysorbate in a concentration of 0.02% (w/v), wherein the polysorbate is polysorbate 20, and wherein said solution has a pH of 6.0.

12 . The solution of claim 1 comprising the anti-CD19 antibody in a concentration of 40 mg/mL, a citrate buffer in a concentration of 25 mM, mannitol in a concentration of 219 mM, sucrose in a concentration of 29 mM, and polysorbate in a concentration of 0.02% (w/v), wherein the polysorbate is polysorbate 20, and wherein said solution has a pH of 6.0.

13 . The solution of claim 1 , wherein said anti-CD19 antibody comprises a heavy chain constant domain of the sequence ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG PDVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQF NSTFRVVSVLTVVHQDWLNGKEYKCKVSNKALPAPEEKTISKTKGQPREPQVYTLPPSR EEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDK SRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK (SEQ ID NO:8) and a light chain constant domain of the sequence RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQ DSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC (SEQ ID NO:9).

14 . The solution of claim 13 , wherein the heavy chain variable region comprises the sequence EVOLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHVWRQAPGKGLEWIGYINPYNDGT KYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCARGTYYYGTRVFDYWGQGTL VTVSS (SEQ ID NO: 10) and the light chain variable region comprises the sequence DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSPQLLIYRMSNL NSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLEYPITFGAGTKLEIK (SEQ ID NO: 11).

15 . The solution of claim 1 , wherein the heavy chain variable region comprises the sequence EVOLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHVWRQAPGKGLEWIGYINPYNDGT KYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCARGTYYYGTRVFDYWGQGTL VTVSS (SEQ ID NO: 10) and the light chain variable region comprises the sequence DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSPQLLIYRMSNL NSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLEYPITFGAGTKLEIK (SEQ ID NO: 11).

16 . The solution of claim 11 , wherein the heavy chain variable region comprises the sequence EVQLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHVWRQAPGKGLEWIGYINPYNDGT KYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCARGTYYYGTRVFDYWGQGTL VTVSS (SEQ ID NO: 10) and the light chain variable region comprises the sequence DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSPQLLIYRMSNL NSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLEYPITFGAGTKLEIK (SEQ ID NO: 11).

17 . The solution of claim 16 , wherein said anti-CD19 antibody comprises a heavy chain constant domain of the sequence ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG PDVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQF NSTFRVVSVLTVVHQDWLNGKEYKCKVSNKALPAPEEKTISKTKGQPREPQVYTLPPSR EEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDK SRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK (SEQ ID NO:8) and a light chain constant domain of the sequence RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQ DSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC (SEQ ID NO:9).

Assignments (2)

Priority Claims (1)

Continuity (2)

References Cited (109)