IP Library › Granted Patent US 12,630,633
Granted Patent B2
US 12,630,633 · App. 16/062,427 · Granted May 19, 2026

Antibody molecules to PD-1 and uses thereof

Inventors: Sanela Bilic (Urbandale, IA); Danny Roland Howard, Jr. (Washington, NJ); John Scott Cameron (Belmont, MA); Glenn Dranoff (Sudbury, MA)
Assignee: Novartis AG
C07K16/2818A61K31/337A61K39/39558A61K45/06A61P35/00A61K2039/545A61K2300/00
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Quick Facts
Patent No.
US 12,630,633
App. No.
16/062,427
Filed
Jun 14, 2018
Granted
May 19, 2026
Kind
B2
Art Unit
1643
USPC
424/133.1
Abstract

Antibody molecules that specifically bind to PD-1 are disclosed. The antibody molecules can be used to treat or prevent cancerous or infectious conditions and disorders.

Claims (48)

1 . A method of treating a cancer in a subject, the method comprising administering to the subject an anti-PD-1 antibody molecule at a flat dose of 300 mg once every three weeks or 400 mg once every four weeks,

wherein the anti-PD-1 antibody molecule comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 91 and a light chain comprising the amino acid sequence of SEQ ID NO: 72; and

wherein the method does not comprise administering an A2AR antagonist to the subject.

2 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with one or more therapeutic agents chosen from one, two, or all of the following categories (i)-(iii):

(i) an agent that enhances tumor antigen presentation chosen from one or more of: a STING agonist, a TLR agonist, an oncolytic virus, a TIM-3 modulator, a vascular endothelial growth factor receptor (VEGFR) inhibitor, a c-Met inhibitor, a TGFb inhibitor, an IDO/TDO inhibitor, a vaccine, or a bi- or tri-specific cell engager;

(ii) an agent that enhances an effector cell response chosen from one or more of: a GITR agonist, a PD-L1 inhibitor, an inhibitor of IAP (Inhibitor of Apoptosis Protein), an inhibitor of EGFR (Epidermal Growth Factor Receptor), an inhibitor of target of rapamycin (mTOR), IL-15 or a variant thereof, a CTLA-4 inhibitor, a bispecific antibody molecule that binds to CD3 and a tumor antigen, a CD40 agonist, an OX40 agonist, or a CD27 agonist; or

(iii) an agent that decreases tumor immunosuppression chosen from one or more of: a GITR agonist, an inhibitor of an immune checkpoint molecule chosen from one or more of PD-L1, LAG-3, TIM-3 or CTLA-4, a CSF-1/1R inhibitor, an IL-17 inhibitor, an IL-1β inhibitor, a CXCR2 inhibitor, an inhibitor of PI3Kγ or PI3Kδ, a BAFF-R inhibitor, a MALT-1/BTK inhibitor, a JAK inhibitor, a CRTH2 inhibitor, a VEGFR inhibitor, an IL-15 or a variant thereof, a CTLA-4 inhibitor, an IDO/TDO inhibitor, a TGFb inhibitor, or a PFKFB3 inhibitor.

3 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered at a flat dose of 300 mg once every three weeks.

4 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered at a flat dose of 400 mg once every four weeks.

5 . The method of claim 1 , wherein the cancer is a solid tumor or a hematological cancer.

6 . The method of claim 1 , wherein the cancer is chosen from a lung cancer, a kidney cancer, a liver cancer, a myeloma, a prostate cancer, a breast cancer, a colorectal cancer (CRC), a gastric cancer, a pancreatic cancer, a thyroid cancer, a neuroendocrine tumor (NET), an ovarian cancer, a fallopian tube cancer, a lymphoma, a leukemia, a myelodysplastic syndrome (MDS), a skin cancer, a brain cancer, a glioblastoma multiforme (GBM), a uterine cancer, an endometrial carcinoma, or a metastatic lesion of the cancer.

7 . The method of claim 6 , wherein the skin cancer is a Merkel cell carcinoma or a melanoma.

8 . The method of claim 6 , wherein the breast cancer is a triple negative breast cancer (TNBC), a HER2-negative breast cancer, or an ER+ breast cancer.

9 . The method of claim 6 , wherein the kidney cancer is a renal cell carcinoma.

10 . The method of claim 9 , wherein the renal cell carcinoma is a clear cell renal cell carcinoma (CCRCC) or a non-clear cell renal cell carcinoma (nccRCC).

11 . The method of claim 6 , wherein the thyroid cancer is an anaplastic thyroid carcinoma (ATC).

12 . The method of claim 6 , wherein the neuroendocrine tumor (NET) is an atypical pulmonary carcinoid tumor or an NET in pancreas, gastrointestinal (GI) tract, or lung.

13 . The method of claim 6 , wherein the lung cancer is a non-small cell lung cancer (NSCLC).

14 . The method of claim 13 , wherein the NSCLC is a squamous NSCLC, a non-squamous NSCLC, or a NSCLC adenocarcinoma.

15 . The method of claim 6 , wherein the colorectal cancer (CRC) is a microsatellite instability-high colorectal cancer (MSI-high CRC) or a microsatellite stable colorectal cancer (MSS CRC).

16 . The method of claim 6 , wherein the leukemia is an acute myeloid leukemia (AML).

17 . The method of claim 16 , wherein the acute myeloid leukemia (AML) is a relapsed or refractory AML or a de novo AML.

18 . The method of claim 6 , wherein the myelodysplastic syndrome (MDS) is a high risk MDS.

19 . The method of claim 6 , wherein the liver cancer is a hepatocellular carcinoma.

20 . The method of claim 6 , wherein the gastric cancer is an EBV+ gastric cancer.

21 . The method of claim 6 , wherein the lymphoma is a non-Hodgkin's lymphoma.

22 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with an IAP inhibitor.

23 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with an mTOR inhibitor.

24 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with a DAC inhibitor.

25 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with an IL-1β inhibitor.

26 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with an IL-17 inhibitor.

27 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with a MEK inhibitor.

28 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with an EGFR inhibitor.

29 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with a CSF-1/1R binding agent.

30 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with an inhibitor of 6-phosphofructo-2-kinase/fructose-2,6-biphosphatase 3 (PFKFB3).

31 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is used in combination with a chemotherapeutic agent, wherein the chemotherapeutic agent is a paclitaxel.

32 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with a BRAF inhibitor and a MEK inhibitor.

33 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with a TGF-β inhibitor.

34 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with an inhibitor of PD-L1.

35 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with a hypomethylating agent.

36 . The method of claim 35 , wherein the combination further comprises an inhibitor of TIM-3.

37 . The method of claim 1 , wherein the anti-PD-1 antibody molecule is administered in combination with a second inhibitor of PD-1.

38 . The method of claim 1 , wherein the cancer comprises a BRAF mutation.

39 . The method of claim 38 , wherein the BRAF mutation is a V600E mutation.

40 . The method of claim 38 , wherein the cancer is a melanoma.

41 . The method of claim 38 , wherein the cancer is a non-small cell lung cancer.

42 . The method of claim 38 , wherein the cancer is a colorectal cancer.

43 . The method of claim 38 , wherein the cancer is a pancreatic cancer.

Continuity (10)
Provisional Application 62431846 · Dec 9, 2016
Provisional Application 62414128 · Oct 28, 2016
Provisional Application 62400787 · Sep 28, 2016
Provisional Application 62381384 · Aug 30, 2016
Provisional Application 62359781 · Jul 8, 2016
Provisional Application 62347331 · Jun 8, 2016
Provisional Application 62344784 · Jun 2, 2016
Provisional Application 62331371 · May 3, 2016
Provisional Application 62269044 · Dec 17, 2015
Related Publication 20180371093A1 · Dec 27, 2018
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