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Method of manufacturing bispecific antibodies, bispecific antibodies and therapeutic use of such antibodies

a technology of bispecific antibodies and antibodies, applied in the field of bivalent bispecific monoclonal antibodies, can solve the problems of difficult depletion of related impurities, and achieve the effects of reducing the number of antibodies

Inactive Publication Date: 2019-01-03
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a method for making bivalent bispecific monoclonal antibodies that have advantages such as using a large antibody repertoire, requiring no extensive protein engineering, limiting the risk for anti-drug antibodies, being cost-effective, and producing high quality material suitable for human use. The method can be used to identify antibodies of kappa and lambla types and deselect combinations where product related impurities are difficult to deplete. The method makes use of a CHO co-expression system at a yield and quality suitable for clinical development and commercialization of biologics.

Problems solved by technology

This is advantageous, because such product related impurities are not easy to deplete using state of the art purification processes.

Method used

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  • Method of manufacturing bispecific antibodies, bispecific antibodies and therapeutic use of such antibodies
  • Method of manufacturing bispecific antibodies, bispecific antibodies and therapeutic use of such antibodies
  • Method of manufacturing bispecific antibodies, bispecific antibodies and therapeutic use of such antibodies

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7. Effects of Combined IL-1β and IL-1β Stimulation and Blockade in PBMC

[0323]Inflammasome activation-dependent cleavage of the effector cytokines IL-1β and IL-1β leads to the induction of secondary pro-inflammatory mediators and promotes immune cell recruitment / activation not only systemically but also at the site of inflammation. In two different mouse models for lethal systemic inflammation (a) LPS injection model and (b) FCAS mice (activating missense mutations in NLRP3), the simultaneous absence / inhibition of both IL-1β and IL-1β was more protective from lethality compared to the single IL-1β or single IL-1β absence / inhibition, demonstrating additive or synergistic mechanisms for immune activation (Brydges 2013, van den Berghe 2014). bbmAb1 is a human / marmoset IL-1β / IL-1β reactive bi-specific mAb with no rodent cross-reactivity and thus cannot be tested in mouse models. Therefore, we used LPS / IL-12 to mimic inflammasome-dependent pathway activation in vitro for the stimulation ...

example 5

9. Pharmaceutical Compositions

[0371]Provided herein are pharmaceutical compositions comprising the bbmAb antibodies, such as bbmAb1, formulated together with a pharmaceutically acceptable carrier. The compositions can additionally contain one or more other therapeutic agents that are suitable for treating a medical condition. Pharmaceutically acceptable carriers enhance or stabilize the composition, or can be used to facilitate preparation of the composition. Pharmaceutically acceptable carriers include solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, and the like that are physiologically compatible.

[0372]A pharmaceutical composition described herein can be administered by a variety of methods known in the art. The route and / or mode of administration vary depending upon the desired results. It is preferred that administration be intravitreal, intravenous, intramuscular, intraperitoneal, or subcutaneous, or administe...

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Abstract

The invention relates to bivalent bispecific monoclonal antibodies (bbmAb) or variants thereof, and methods of manufacturing such antibodies by co-expressing modified Fc-mutated derivatives of two different monoclonal antibodies in mammalian cell lines.

Description

STATEMENT OF RELATED APPLICATIONS[0001]This application claims priority to U.S. provisional patent application No. 62 / 518,090, filed Jun. 12, 2017, the contents of which are incorporated herein by reference in their entirety.SEQUENCE LISTING[0002]The instant application contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on May 30, 2018, is named PAT057716-WO-PCT_SL.txt and is 68,498 bytes in size.TECHNICAL FIELD[0003]The invention relates to bivalent bispecific monoclonal antibodies (bbmAb) or variants thereof, and methods of manufacturing such antibodies by co-expressing so called knob-into-hole modified FC-mutated derivatives of two different monoclonal antibodies in mammalian cell lines.BACKGROUND OF THE DISCLOSURE[0004]Bispecific antibodies, i.e. antibodies binding to two distinct epitopes, are well known in the art. One approach for generating bispecific antibodies...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C07K16/46C07K16/28A61P9/14A61P9/10A61P1/00
CPCC07K16/468C07K16/2863C07K16/2887A61P9/14A61P9/10A61P1/00C07K2317/24C07K2317/31C07K2317/526C07K2317/53C07K2319/00C07K16/00C07K16/244C07K16/245C07K16/46C07K2317/51C07K2317/515
Inventor BARDROFF, MICHAEL OTTOBUCH, TINAGRAF, CHRISTIANHEITMANN, DANIELJOSTOCK, THOMASKNOPF, HANS-PETERKOEHLER, ROLFKOVARIK, JIRIOLIVER, STEPHEN JOHNPATEL, DHAVALKUMARWOISETSCHLAEGER, MAXIMILIAN
Owner NOVARTIS AG
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