Anti-il4-il 13 bispecific antibodies

a technology of bispecific antibodies and anti-il4-il 13, which is applied in the field of anti-il4-il 13 bispecific antibodies, can solve the problems of delaying the progression of fibrosis in ipf patients, and achieve the effect of preventing the progression of fibrosis

Inactive Publication Date: 2017-05-25
SANOFI SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0010]In another aspect, the invention provides methods of determining whether a dose comprising a dual-V-region antibody-like protein or a fragment thereof administered to a human subject specifically binds to IL-4 or IL-13 within the human subject, the method comprising: (a) administering the dose to the human subject; and (b) measuring the amount of TARC/CCL17 protein in a blood, plasma, or serum sample drawn from the human subject, wherein a decrease in the amount of TARC/CCL17 in the blood sample relative to an amount of TARC/CCL17 in the subject measured before the dose was administered signifies binding of the dual-V-region antibody-like protein or fragment thereof to IL-4 or IL-13. In some embodiments, the methods further comprise step (c): increasing or decreasing the dose depending on the magnitude of the decrease in TARC/CCL17 measured in ste

Problems solved by technology

Such evidence suggests that therapies capable of suppressing or neutralizing these c

Method used

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  • Anti-il4-il 13 bispecific antibodies
  • Anti-il4-il 13 bispecific antibodies
  • Anti-il4-il 13 bispecific antibodies

Examples

Experimental program
Comparison scheme
Effect test

example 1

Study Format

[0101]A multi-center, randomized, double-blind, placebo-controlled clinical study was conducted to assess the safety and tolerability of repeated doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period in up to 3 sequential, ascending dose cohorts of patients with idiopathic pulmonary fibrosis (IPF). IPF is a progressive, diffuse, and distinct chronic fibrosing interstitial pneumonia of unknown cause that is uniformly fatal with a median survival of 2 to 3 years.

[0102]In each dose cohort, 8 patients (6 receiving SAR156597 and 2 receiving placebo) received repeated SC, once-weekly doses of SAR156597 or matching placebo control. The second cohort was initiated after the review of the safety of the first cohort by the DMC. The third cohort at a dose of 200 mg was initiated after the review of the safety of the 2 preceding cohorts.

[0103]For each patient, the study duration was 22 weeks, as follows: 4 weeks of screening; 6 weeks of treatment perio...

example 2

ynamics (PD) Evaluations

[0136]The effect of repeated ascending doses of SAR156597 was evaluated on pulmonary function tests (PFTs), respiratory symptoms, and on selected biomarkers. More specifically, the following PD variables were evaluated:

[0137]1. Pulmonary function test (PFT): Carbon monoxide diffusing capacity, corrected for hemoglobin (DLCO); Forced (expiratory) vital capacity (FVC); Forced expiratory volume over 1 second (FEV1); Total lung capacity (body plethysmography) (TLC); Residual volume (body plethysmography) (RV). Two PFTs were performed within 3 weeks prior to dosing. The first PFT was performed to screen the patient and the data from the second PFT (at the randomization visit) was averaged with the first one to establish a baseline value; these tests were performed on separate days. A PFT was also performed at Visit 8 (Week 6) / end-of-treatment (EOT) and Visit 14 (Week 18 / 12 weeks following the last dose of study treatment).

[0138]2. Oxygen saturation was assessed us...

example 3

of Safety Data

[0145]A safety evaluation was based upon the review of the individual values (clinically significant abnormalities), descriptive statistics (summary tables, graphics). All the safety analyses were performed using the safety population.

[0146]For all safety data, the observation period were divided into 3 phases:[0147]The pre-treatment phase, defined as the time between when the patients give informed consent and the first dose of IMP administration.[0148]The on-treatment phase, defined as the time from the first dose of IMP administration up to the Week 18 visit (included).[0149]The post-treatment phase, defined as the time after the Week 18 visit (excluded).

[0150]Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) using version 16.1.

[0151]For clinical laboratory, vital signs, and ECG parameters, and the potentially clinically significant abnormalities (PCSAs) were analyzed using the PCSA list shown in Table 2.

TABLE 2Criteria...

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Abstract

Disclosed herein are safe doses of dual-V-region antibody-like binding proteins or fragments thereof, as well as methods for assessing binding of dual-V-region antibody-like proteins or fragments thereof to their targets, and methods of treating idiopathic pulmonary fibrosis (IPF) by administering safe doses of dual-V-region antibody-like binding proteins or fragments thereof. In some embodiments, the dual-V-region antibody-like binding proteins or fragments thereof bind both IL-4 and IL-13.

Description

BACKGROUND OF THE INVENTION[0001]Interleukin-4 (IL-4) is a pleiotropic cytokine that has a broad spectrum of biological effects on lymphoid B and T cells, and many non-lymphoid cells including monocytes, endothelial cells and fibroblasts. For example, IL-4 induces the expression of class II major histocompatibility complex molecules on resting B cells, and enhances the secretion of IgG4 and IgE by human B cells. IL-4 is associated with a Th2-type immune response, and is produced by and promotes differentiation of Th2 cells. IL-4 has been implicated in a number of disorders, such as allergy and asthma.[0002]IL-13 is a cytokine of 112 amino acids secreted by the activated T lymphocytes, the B lymphocytes and the mastocytes after activation (Minty, A. et al., Nature, 1993, 362, 248-250, and McKenzie, A. N. et al., Proc. Natl. Acad. Sci. U.S.A, 1993, 90, 3735-3739). By virtue of its numerous biological properties shared with IL-4, IL-13 has been described as an IL-4-like cytokine. Its a...

Claims

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Application Information

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IPC IPC(8): C07K16/24C07K14/52G01N33/68C07K16/46
CPCC07K16/247C07K16/244C07K16/468C07K14/521G01N33/6893C07K2317/31G01N2800/52A61K2039/54A61K2039/545C07K2317/92C07K2317/94G01N2333/521A61K2039/505C07K2317/33C07K2317/76C07K2317/90A61K39/02A61K39/395A61P11/00
Inventor ESPERET, CORRINEJAGERSCHMIET, ALEXANDRESOUBRANE, CHRISTINASUBRAMANIAM, ARUN
Owner SANOFI SA
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