IP Library › Granted Patent US 12,631,639
Granted Patent B2
US 12,631,639 · App. 17/824,266 · Granted May 19, 2026

Methods for predicting therapeutic benefit of anti-CD19 therapy in patients

Inventors: Jan Endell (Munich, DE); Mark Winderlich (Munich, DE); Rainer Boxhammer (Aying, DE)
Assignee: Incyte Corporation
G01N33/57426A61P35/02A61P35/04C07K16/2896G01N33/57492A61K39/395A61K2039/505G01N2333/70535G01N2800/52
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Quick Facts
Patent No.
US 12,631,639
App. No.
17/824,266
Granted
May 19, 2026
Kind
B2
Abstract

The present disclosure is directed to identifying characteristics and biomarkers in patients that benefit from treatment with an anti-CD19 antibody.

Claims (56)

1 . A method for the treatment of a human subject having a non-Hodgkin's lymphoma, said method comprising:

identifying the human subject as having a peripheral natural killer (NK) cell count at baseline of at least 100 NK cells/μl in a blood sample obtained from the human subject; and

administering an anti-CD19 antibody to the human subject, wherein the anti-CD19 antibody comprises an HCDR1 region comprising the sequence SYVMH (SEQ ID NO:1), an HCDR2 region comprising the sequence NPYNDG (SEQ ID NO:2), an HCDR3 region comprising the sequence GTYYYGTRVFDY (SEQ ID NO:3), an LCDR1 region comprising the sequence RSSKSLONVNGNTYLY (SEQ ID NO:4), an LCDR2 region comprising the sequence RMSNLNS (SEQ ID NO:5), and an LCDR3 region comprising the sequence MQHLEYPIT (SEQ ID NO:6).

2 . The method according to claim 1 , wherein the anti-CD19 antibody comprises a heavy chain variable region of the sequence

(SEQ ID NO: 10)

EVQLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHWVRQAPGKGLEWIG

YINPYNDGTKYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCAR

GTYYYGTRVFDYWGQGTLVTVSS

and

a light chain variable variable region of the

sequence

(SEQ ID NO: 11)

DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSP

QLLIYRMSNLNSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLE

YPITFGAGTKLEIK.

3 . The method according to claim 1 , wherein the anti-CD19 antibody comprises a heavy chain comprising the sequence

(SEQ ID NO: 8)

EVQLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHWVRQAPGKGLEWIG

YINPYNDGTKYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCAR

GTYYYGTRVFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALG

CLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSS

LGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPDVF

LFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTK

PREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKALPAPEEKTISKT

KGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPE

NNYKTTPPMLDSDGSFFLYSKLIVDKSRWQQGNVFSCSVMHEALHNHYT

QKSLSLSPGK

and

a light chain comprising the sequence

(SEQ ID NO: 9)

DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSP

QLLIYRMSNLNSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLE

YPITFGAGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASWCLLNNFYPRE

AKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVY

ACEVTHQGLSSPVTKSFNRGEC.

4 . The method according to claim 1 , wherein the non-Hodgkin's lymphoma is follicular lymphoma.

5 . The method according to claim 4 , wherein the anti-CD19 antibody comprises a heavy chain variable region comprising the sequence set forth in SEQ ID NO:10 and a light chain variable region comprising the sequence set forth in SEQ ID NO:11.

6 . The method according to claim 4 , wherein the anti-CD19 antibody comprises a heavy chain comprising the sequence set forth in SEQ ID NO:8 and a light chain comprising the sequence set forth in SEQ ID NO:9.

7 . The method according to claim 1 , wherein the non-Hodgkin's lymphoma is small lymphocytic lymphoma.

8 . The method according to claim 7 , wherein the anti-CD19 antibody comprises a heavy chain variable region comprising the sequence set forth in SEQ ID NO:10 and a light chain variable region comprising the sequence set forth in SEQ ID NO:11.

9 . The method according to claim 7 , wherein the anti-CD19 antibody comprises a heavy chain comprising the sequence set forth in SEQ ID NO:8 and a light chain comprising the sequence set forth in SEQ ID NO:9.

10 . The method according to claim 1 , wherein the non-Hodgkin's lymphoma is mucosa-associated lymphoid tissue lymphoma.

11 . The method according to claim 10 , wherein the anti-CD19 antibody comprises a heavy chain variable region comprising the sequence set forth in SEQ ID NO:10 and a light chain variable region comprising the sequence set forth in SEQ ID NO:11.

12 . The method according to claim 10 , wherein the anti-CD19 antibody comprises a heavy chain comprising the sequence set forth in SEQ ID NO:8 and a light chain comprising the sequence set forth in SEQ ID NO:9.

13 . The method according to claim 1 , wherein the non-Hodgkin's lymphoma is marginal zone lymphoma.

14 . The method according to claim 13 , wherein the anti-CD19 antibody comprises a heavy chain variable region comprising the sequence set forth in SEQ ID NO:10 and a light chain variable region comprising the sequence set forth in SEQ ID NO:11.

15 . The method according to claim 13 , wherein the anti-CD19 antibody comprises a heavy chain comprising the sequence set forth in SEQ ID NO:8 and a light chain comprising the sequence set forth in SEQ ID NO:9.

16 . The method according to claim 1 , wherein the non-Hodgkin's lymphoma is diffuse large B cell lymphoma.

17 . The method according to claim 16 , wherein the anti-CD19 antibody comprises a heavy chain variable region comprising the sequence set forth in SEQ ID NO:10 and a light chain variable region comprising the sequence set forth in SEQ ID NO:11.

18 . The method according to claim 16 , wherein the anti-CD19 antibody comprises a heavy chain comprising the sequence set forth in SEQ ID NO:8 and a light chain comprising the sequence set forth in SEQ ID NO:9.

19 . The method according to claim 1 , wherein the non-Hodgkin's lymphoma is Burkitt's lymphoma.

20 . The method according to claim 19 , wherein the anti-CD19 antibody comprises a heavy chain variable region comprising the sequence set forth in SEQ ID NO: 10 and a light chain variable region comprising the sequence set forth in SEQ ID NO:11.

21 . The method according to claim 19 , wherein the anti-CD19 antibody comprises a heavy chain comprising the sequence set forth in SEQ ID NO:8 and a light chain comprising the sequence set forth in SEQ ID NO:9.

22 . The method according to claim 1 , wherein the non-Hodgkin's lymphoma is mantle cell lymphoma.

23 . The method according to claim 22 , wherein the anti-CD19 antibody comprises a heavy chain variable region comprising the sequence set forth in SEQ ID NO: 10 and a light chain variable region comprising the sequence set forth in SEQ ID NO:11.

24 . The method according to claim 22 , wherein the anti-CD19 antibody comprises a heavy chain comprising the sequence set forth in SEQ ID NO:8 and a light chain comprising the sequence set forth in SEQ ID NO:9.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 22, 2024
From: MORPHOSYS AG; MORPHOSYS US INC.
To: INCYTE CORPORATION
Reel/Frame 066645/0172 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 26, 2022
From: ENDELL, JAN; WINDERLICH, MARK; BOXHAMMER, RAINER
To: MORPHOSYS AG
Reel/Frame 060026/0708 →
Priority Claims (1)
EP 16171885 · May 30, 2016 · regional
Continuity (2)
Continuation 16305482
Related Publication 20220283166A1 · Sep 8, 2022
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