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Last Updated: March 29, 2024

Claims for Patent: 8,460,662


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Summary for Patent: 8,460,662
Title:Compositions and methods relating to anti-IGF-1 receptor antibodies
Abstract: The present invention provides compositions and methods relating to or derived from anti-IGF-1R antibodies. In particular embodiments, the invention provides fully human, humanized, or chimeric anti-IGF-1R antibodies that bind human IGF-1R, IGF-1R-binding fragments and derivatives of such antibodies, and IGF-1R-binding polypeptides comprising such fragments. Other embodiments provide nucleic acids encoding such antibodies, antibody fragments and derivatives and polypeptides, cells comprising such polynucleotides, methods of making such antibodies, antibody fragments and derivatives and polypeptides, and methods of using such antibodies, antibody fragments and derivatives and polypeptides, including methods of treating or diagnosing subjects having IGF-1R-related disorders or conditions.
Inventor(s): Calzone; Frank J. (Westlake Village, CA), Deshpande; Rajendra V. (Thousand Oaks, CA), Tsai; Mei-Mei (Thousand Oaks, CA)
Assignee: Amgen Inc. (Thousand Oaks, CA)
Application Number:13/432,472
Patent Claims:1. A method of alleviating or reducing pancreatic cancer in a human subject comprising administering to said subject an anti-human IGF1-R antibody, or an antigen binding fragment thereof, wherein said anti-human IGF1-R antibody or fragment comprises a light chain variable region and a heavy chain variable region, and wherein: a. said light chain variable region comprises the amino acid sequence of SEQ ID NO:32; and said heavy chain variable region comprises the amino acid sequence of SEQ ID NO:136; or b. said light chain variable region comprises: i. the CDR 1 sequence of residues 24 through 39 of SEQ ID NO:32; and ii. the CDR 2 sequence of residues 55 through 61 of SEQ ID NO:32; and iii. the CDR 3 sequence of residues 94 through 102 of SEQ ID NO:32; and said heavy chain variable region comprises: i. the CDR 1 sequence of residues 31 through 36 of SEQ ID NO:136; and ii. the CDR 2 sequence of residues 51 through 66 of SEQ ID NO:136; and iii. the CDR 3 sequence of residues 99 through 108 of SEQ ID NO:136.

2. The method of claim 1 wherein said tumor is a primary tumor.

3. The method of claim 1 wherein said tumor is a metastatic tumor.

4. The method of claim 1 wherein said tumor is a carcinoma.

5. The method of claim 1 wherein said pancreatic cancer is an islet cell pancreatic cancer.

6. The method of claim 1 further comprising administering to said subject a second treatment selected from the group consisting of radiation treatment, surgery, chemotherapy, anti-hormone therapy, and a pharmaceutical composition comprising a therapeutic agent.

7. The method of claim 6 wherein said second treatment is administered to said subject before or simultaneously with or after said anti-human IGF1-R antibody or antigen binding fragment thereof is administered to said subject.

8. The method of claim 6 wherein said chemotherapy treatment comprises treatment with a mitotic inhibitor, alkylating agent, anti-metabolite, intercalating antibiotic, growth factor inhibitor, cell cycle inhibitor, enzyme, topoisomerase inhibitor, anti-survival agent, biological response modifier, anti-hormone agent, anti-androgen agent, anti-angiogenesis agent, CPT-11, irenotecan, camptothecin, or SN38.

9. The method of claim 6 wherein said therapeutic agent is a corticosteroid, an anti-emetic, ondansetron hydrochloride, granisetron hydrochloride, metroclopramide, domperidone, haloperidol, cyclizine, lorazepam, prochlorperazine, dexamethasone, levomepromazine, tropisetron, a GM-CSF inhibiting agent, an analgesic, ibuprofen, naproxen, choline magnesium trisalicylate, an oxycodone hydrochloride, an anti-angiogenic agent, an anti-vascular agent, bevacizumab, an anti-VEGF antibody, an anti-VEGF receptor antibody, a soluble VEGF receptor, an anti-TWEAK antibody, an anti-TWEAK receptor antibody, a soluble TWEAK receptor, AMG 706, AMG 386, an anti-proliferative agent, a farnesyl protein transferase inhibitor, an .alpha.v.beta.3 inhibitor, an .alpha.v.beta.5 inhibitor, a p53 inhibitor, a Kit receptor inhibitor, a ret receptor inhibitor, a PDGFR inhibitor, a growth hormone secretion inhibitor, an angiopoietin inhibitor, a tumor infiltrating macrophage-inhibiting agent, a c-fms inhibiting agent, an anti-c-fms antibody, a CSF-1 inhibiting agent, an anti-CSF-1 antibody, a soluble c-fms fragment, pegvisomant, gemcitabine, panitumumab, denosumab, irinothecan, SN-38, imatinib mesylated, gefitinib, cetuximab, PTK787, SU11248, erlototinib, 43-9006, CCI-779, RAD001, BMS-387032, IMC-1C11, LY333531, PD 184352, 2C4, or GW2016.

10. The method of claim 6 further comprising administering to said subject a third treatment comprising gemcitabine.

11. The method of claim 6, wherein said second treatment comprises administering to said subject gemcitabine.

12. The method of claim 1 wherein said anti-human IGF1-R antibody or fragment further comprises: a. the kappa light chain constant sequence of SEQ ID NO:234, b. the IgG1 heavy chain constant sequence of SEQ ID NO:235, or c. the kappa light chain constant sequence of SEQ ID NO:234 and the IgG1 heavy chain constant sequence of SEQ ID NO:235.

13. The method of claim 1 wherein said anti-human IGF1-R antibody or fragment: a. cross-competes with a reference antibody for binding to IGF-1R; or b. binds to the same epitope of IGF-1R as said reference antibody; wherein said reference antibody comprises the light chain and heavy chain variable domain sequences of SEQ ID NO: 32 and SEQ ID NO: 136, respectively.

14. The method of claim 1 wherein said anti-human IGF1-R antibody or fragment, when bound to a human IGF-1R, inhibits binding of IGF-1 and IGF-2 to said human IGF-1R.

15. The method of claim 1 wherein said anti-human IGF1-R antibody or fragment inhibits the growth of a MCF-7 human breast cancer cell by greater than about 80% in the presence of a growth stimulant selected from the group consisting of serum, IGF-1, and IGF-2.

16. The method of claim 1 wherein said anti-human IGF1-R antibody or fragment binds to human IGF-1R with a selectivity that is at least fifty times greater than its selectivity for human insulin receptor.

17. The method of claim 1 wherein said anti-human IGF1-R antibody or fragment inhibits tumor growth in vivo.

18. The method of claim 1 wherein said anti-human IGF1-R antibody or fragment inhibits IGF-1R mediated tyrosine phosphorylation.

19. The method of claim 1 wherein said anti-human IGF1-R antibody or fragment comprises: a. a human antibody; b. a humanized antibody; c. a chimeric antibody; d. a monoclonal antibody; e. a recombinant antibody; f. a single chain antibody; g. a diabody; h. a triabody; i. a tetrabody; j. a Fab fragment; k. a F(ab').sub.2 fragment; l. a domain antibody; m. an IgD antibody; n. an IgE antibody; o. an IgM antibody; p. an IgG1 antibody; q. an IgG2 antibody; r. an IgG3 antibody; s. an IgG4 antibody; or t. an IgG4 antibody having at least one mutation in a hinge region that alleviates a tendency to form intra-H chain disulfide bond.

20. The method of claim 1 wherein said light chain variable region has the sequence of SEQ ID NO:32; and said heavy chain variable region has the sequence of SEQ ID NO:136.

21. The method of claim 1 wherein said light chain comprises the variable region of SEQ ID NO:32 and the kappa light chain constant sequence of SEQ ID NO:234 and the heavy chain comprises the heavy chain variable region of SEQ ID NO:136 and the IgG1 heavy chain constant sequence of SEQ ID NO:235.

Details for Patent 8,460,662

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Pharmacia & Upjohn Company Llc SOMAVERT pegvisomant For Injection 021106 03/25/2003 ⤷  Try a Trial 2024-12-22
Pharmacia & Upjohn Company Llc SOMAVERT pegvisomant For Injection 021106 07/31/2014 ⤷  Try a Trial 2024-12-22
Eli Lilly And Company ERBITUX cetuximab Injection 125084 02/12/2004 ⤷  Try a Trial 2024-12-22
Eli Lilly And Company ERBITUX cetuximab Injection 125084 03/28/2007 ⤷  Try a Trial 2024-12-22
Genentech, Inc. AVASTIN bevacizumab Injection 125085 02/26/2004 ⤷  Try a Trial 2024-12-22
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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