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Monoclonal antibodies for tumor treatment

A monoclonal antibody, tumor technology, applied in the fields of therapy, antibodies, anti-tumor drugs, etc., can solve the problem of reducing anti-tumor activity and efficacy

Inactive Publication Date: 2011-02-09
CURETECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

BAT exerts antitumor activity in athymic nude and beige mice, but this activity is less potent than that of BAT in wild-type mice

Method used

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  • Monoclonal antibodies for tumor treatment
  • Monoclonal antibodies for tumor treatment
  • Monoclonal antibodies for tumor treatment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0179] Example 1. In vitro functional assays

[0180] Functional assays are based on the ability of hBAT-1 to increase the survival of cultured murine and human lymphocytes. In this example, the effect of hBAT-1 alone or in combination with chemotherapeutic agents on the enhanced survival of lymphocytes was assessed and expressed by % difference in cell survival or by the area under the dose response curve (AUC expressed as % difference X μg / ml). Chemotherapeutic agents were administered with or 24 hours after hBAT-1 treatment at the indicated concentrations. Chemotherapeutic agents tested by functional assays included 5FU (Figures 1, 2, and 7), SN-38, active derivatives of irinotecan (Figures 3 and 4), cisplatin, oxaliplatin, Taxol (paclitaxel), and dacarba zine (Figures 5 and 7), cytarabine, cyclophosphamide, and doxorubicin (Figure 6).

[0181] The results indicate that specific agents (eg, 5FU, cisplatin, oxaliplatin, paclitaxel, and cytarabine) do not adversely affect...

Embodiment 2

[0182] Example 2. Combination therapy for colorectal cancer

[0183] Colorectal cancer (CT26 tumors) was induced by S.C. injection of CT26 cells, 10 6 Cells / mouse (n=6). The day of injection refers to Day 0. 20 mg / kg of 5-FU was administered I.P. on days 6-9, 15-17, 22-24 and 29-31 , 36-38 and 43-45. On days 10, 18, 25, 32 and 39, 10 mg / mouse of hBAT-1 ( Figure 8-10 ). Relapse cases after complete remission (observed only in the combination therapy group) were further administered with 20 mg / kg of 5FU on days 73-74, 77-80, 85-87, 92-93 and 10 mg / kg I.V. on days 81 and 88. hBAT-1 treatment of mice.

[0184] In a follow-up study of tumor size after one treatment cycle, tumor volumes were measured on alternate days from days 4 to 16 after tumor inoculation. The results showed that combined treatment with 5FU was superior to treatment with 5FU or hBAT-1 alone ( Figure 8 ).

[0185] In a follow-up study of tumor size after 3 alternating treatment cycles, tumor volumes w...

Embodiment 3

[0187] Example 3. Combination Therapy for Melanoma

[0188] with B16 melanoma cells at 5x10 5 Cells / mouse Mice (n=7) were inoculated subcutaneously. The day of inoculation refers to day 0. 50 mg / kg of 5-FU was administered intraperitoneally on days 1-4 and 7-8. In the combined treatment group, a single dose of 10 mg / mouse of hBAT-1 was injected intravenously on the 10th day.

[0189] Monitoring of percent survival began on day 8. The percent survival in mice treated with combination therapy was significantly higher than in mice treated with high doses of 5FU ( Figure 11 ).

[0190] Otherwise stated, combination therapy using a sequential administration schedule in which the humanized antibody was administered after a 9-day cycle of 5FU at dose-limiting toxicity (DLT) levels (50 mg / kg / day) resulted in enhanced survival of mice. The results clearly show that the combination therapy improves tolerance to DLT levels of 5-FU.

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PUM

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Abstract

The present invention relates to methods for inhibiting tumor growth, increasing survival of a subject having a tumor and inducing protection against tumor recurrence in a mammal. The methods comprise administering a humanized monoclonal antibody comprising CDR regions derived from the murine monoclonal antibody designated mBAT-1, in combination with at least one chemotherapeutic agent.

Description

field of invention [0001] The present invention relates to methods of inhibiting tumor growth, increasing survival of a subject bearing a tumor, and inducing protection against tumor recurrence in a mammal. The method comprises administering a humanized monoclonal antibody comprising CDR regions derived from a murine monoclonal antibody designated mBAT-1 in combination with at least one chemotherapeutic agent. Background of the invention [0002] Knowledge about the molecular and cellular basis of immune regulation, especially at the level of T-cell responses, has grown rapidly in recent years, providing a new arsenal for the development of immunotherapeutic approaches, including tumor vaccines. Certain monoclonal antibodies have been shown to have immunomodulatory activity, including the ability to bind to T cell surface determinants and the ability to induce the proliferation, activation, maturation or differentiation of these cells. [0003] BAT (also known as mBAT-1 or ...

Claims

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Application Information

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IPC IPC(8): C07K16/30A61K39/395
CPCC07K16/3061A61N5/00C07K16/18A61K39/39558A61K31/513A61K31/337A61K31/7068A61K31/282A61P35/00A61P35/02A61P43/00A61K2300/00
Inventor R·罗泰姆-耶胡达G·罗迪诺
Owner CURETECH LTD
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