Claims for Patent: 9,687,568
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Summary for Patent: 9,687,568
Title: | Composition of a first non-labeled monoclonal antibody binding to a tumor antigen and a non-cross reactive second monoclonal antibody labeled with a NIR fluorescence label |
Abstract: | This invention relates to a composition of a non-labeled monoclonal antibody binding to a tumor antigen and a second monoclonal antibody labeled with a NIR fluorescence label, binding to the same tumor antigen, wherein the first and second antibody exhibit no cross reactivity. The composition can be used for the treatment of patients suffering of solid tumors which are associated with an overexpression of such a tumor antigen. The invention further relates to a the co-administration of said first and second antibody as wells as to a method of acquiring a NIR fluorescence images of such tumors or the patients suffering from such tumors during the treatment of said patient with such composition. |
Inventor(s): | Hasmann; Max (Munich, DE), Lenz; Helmut (Tutzing, DE), Scheuer; Werner (Penzberg, DE) |
Assignee: | HOFFMANN-LA ROCHE INC. (Little Falls, NJ) |
Application Number: | 13/961,167 |
Patent Claims: | 1. A method for near-infrared (NIR) fluorescence imaging of solid tumors in a patient during treatment with a first non-labeled monoclonal antibody, wherein the method
comprises: a) administering to the patient a dose of the first non-labeled monoclonal antibody, wherein the first non-labeled monoclonal antibody specifically binds to a tumor antigen in the solid tumor; b) administering to the patient a dose of a
second monoclonal antibody labeled with a NIR fluorescence label, wherein the second labeled monoclonal antibody also specifically binds to the tumor antigen, wherein the first and second monoclonal antibodies exhibit no cross reactivity; and c)
measuring the NIR fluorescence signal of the second labeled monoclonal antibody in a region of the solid tumor.
2. The method of claim 1, wherein the signal/background ratio of the NIR fluorescence signal is at least 1.5. 3. The method of claim 1, wherein the first non-labeled monoclonal antibody is an anti-HER2 antibody. 4. The method of claim 3, wherein the first non-labeled monoclonal antibody is trastuzumab or pertuzumab. 5. The method of claim 1, wherein the first non-labeled monoclonal antibody is an anti-EGFR antibody. 6. The method of claim 5, wherein the first non-labeled monoclonal antibody is cetuximab or rhMab ICR62. 7. The method of claim 1, wherein the first non-labeled monoclonal antibody and the second labeled monoclonal antibody are co-administered to the patient during the treatment. 8. The method of claim 7, wherein the first non-labeled monoclonal antibody and the second labeled monoclonal antibody are co-administered simultaneously during the treatment. 9. The method of claim 7, wherein the first non-labeled monoclonal antibody and the second labeled monoclonal antibody are co-administered sequentially in either order during the treatment. 10. The method of claim 9, wherein the first non-labeled monoclonal antibody and the second labeled monoclonal antibody are co-administered in separate formulations. 11. A method for treating a patient suffering from a solid tumor overexpressing a tumor antigen, the method comprising: a) administering to the patient a first dose of a monoclonal antibody labeled with a near-infrared (NIR) fluorescence label, wherein the labeled monoclonal antibody specifically binds to the tumor antigen; b) measuring the NIR fluorescence signal in a region of the solid tumor, following the first dose of the labeled monoclonal antibody; c) administering to the patient a first dose of non-labeled monoclonal antibody, wherein the non-labeled monoclonal antibody also specifically binds to the tumor antigen, wherein the first and second monoclonal antibodies exhibit no cross reactivity; d) administering to the patient a second dose of the labeled monoclonal antibody labeled with a NIR fluorescence; e) measuring the NIR fluorescence signal in a region of the solid tumor, following the second dose of the labeled monoclonal antibody; and f) administering to the patient a second dose of the non-labeled monoclonal antibody, based on a decrease by at least 10% in the NIR fluorescence signal measured in step e) compared to the NIR fluorescence signal measured in step b). 12. The method of claim 11, wherein the administering in step f) is based on a decrease by at least 20% in the NIR fluorescence signal measured in step e) compared to the NIR fluorescence signal measured in step b). 13. The method of claim 11, wherein the administering in step f) is based on a decrease by at least 30% in the NIR fluorescence signal measured in step e) compared to the NIR fluorescence signal measured in step b). 14. The method of claim 11, wherein the non-labeled monoclonal antibody is an anti-HER2 antibody. 15. The method of claim 14, wherein the non-labeled monoclonal antibody is trastuzumab or pertuzumab. 16. The method of claim 11, wherein the non-labeled monoclonal antibody is an anti-EGFR antibody. 17. The method of claim 16, wherein the non-labeled monoclonal antibody is cetuximab or rhMab ICR62. 18. A method for near-infrared (NIR) fluorescence imaging of solid tumors in a patient during treatment with a first non-labeled monoclonal antibody, wherein the method comprises: a) co-administering to the patient in a single formulation a dose of the first non-labeled monoclonal antibody and a second monoclonal antibody labeled with a NIR fluorescence label, wherein the first non-labeled monoclonal antibody specifically binds to a tumor antigen in the solid tumor and the second labeled monoclonal antibody also specifically binds to the tumor antigen, wherein the first and second monoclonal antibodies exhibit no cross reactivity; and b) measuring the NIR fluorescence signal of the second labeled monoclonal antibody in a region of the solid tumor. 19. The method of claim 18, wherein the signal/background ratio of the NIR fluorescence signal is at least 1.5. 20. The method of claim 18, wherein the first non-labeled monoclonal antibody is an anti-HER2 antibody. 21. The method of claim 20, wherein the first non-labeled monoclonal antibody is trastuzumab or pertuzumab. 22. The method of claim 18, wherein the first non-labeled monoclonal antibody is an anti-EGFR antibody. 23. The method of claim 22, wherein the first non-labeled monoclonal antibody is cetuximab or rhMab ICR62. |
Details for Patent 9,687,568
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Genentech, Inc. | HERCEPTIN | trastuzumab | For Injection | 103792 | 09/25/1998 | ⤷ Try a Trial | 2027-06-06 |
Genentech, Inc. | HERCEPTIN | trastuzumab | For Injection | 103792 | 02/10/2017 | ⤷ Try a Trial | 2027-06-06 |
Eli Lilly And Company | ERBITUX | cetuximab | Injection | 125084 | 02/12/2004 | ⤷ Try a Trial | 2027-06-06 |
Eli Lilly And Company | ERBITUX | cetuximab | Injection | 125084 | 03/28/2007 | ⤷ Try a Trial | 2027-06-06 |
Genentech, Inc. | PERJETA | pertuzumab | Injection | 125409 | 06/08/2012 | ⤷ Try a Trial | 2027-06-06 |
Genentech, Inc. | HERCEPTIN HYLECTA | trastuzumab and hyaluronidase-oysk | Injection | 761106 | 02/28/2019 | ⤷ Try a Trial | 2027-06-06 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
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