Selective IL-6 Trans-Signalling Inhibitor With gp130-Fc Dimer

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Solution Overview

Problem

Existing IL-6 trans-signalling inhibitors have limitations in binding affinity, immunogenic potential, and toxicity, and often cause side effects such as decreased neutrophil and platelet counts and lower levels of C-reactive protein.

Innovation Solution

A polypeptide dimer comprising two monomers with at least 90% sequence identity to SEQ ID NO: 1, which selectively inhibits IL-6 trans-signalling without interfering with classic signalling, administered at doses of 60 mg to 3 g, is developed to treat inflammatory diseases.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing IL-6 trans-signalling inhibitors are used, then IL-6 trans-signalling is inhibited, but binding affinity and inhibitory activity are insufficient

Engineering Contradiction:
Improveinhibitory activityVSAvoidmolecule structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent uses a composite structure combining the extracellular domain of human gp130 (which provides high affinity binding to the IL-6/sIL-6R complex) with the Fc region of human IgG1 (which provides dimerization capability and extends half-life). This composite gp130-Fc dimer structure achieves superior inhibitory activity compared to natural sgp130 alone, while maintaining a biologically reasonable molecular complexity.

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If IL-6 trans-signalling is inhibited, then chronic inflammation is treated, but neutrophil and platelet counts decrease

Engineering Contradiction:
Improvechronic inflammationVSAvoiddecreased neutrophil and platelet counts
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The gp130-Fc dimer exhibits selective inhibition of IL-6 trans-signalling while sparing classic IL-6 signalling. This local quality differentiation allows the drug to target specifically the pathological trans-signalling pathway involved in chronic inflammation, while preserving the classic signalling pathway that maintains normal hematopoiesis and acute phase responses, thus avoiding decreases in neutrophil and platelet counts.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

Instead of blocking IL-6 from binding to both membrane-bound IL-6R and soluble sIL-6R (as traditional antibodies do), the gp130-Fc dimer works by binding to the IL-6/sIL-6R complex and preventing it from engaging with gp130. This inverted mechanism selectively interrupts trans-signalling while leaving classic signalling intact, thereby treating inflammation without causing hematological side effects.

Inventive Principle:
Principle #13The other way round (Inversion)

3Reliability

If IL-6 trans-signalling inhibitor is administered, then disease-promoting T-cell populations are prevented from apoptosis, but immunogenic potential and toxicity increase

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidimmunogenic potential and toxicity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The gp130-Fc dimer utilizes parameter changes in its molecular structure - specifically, the fusion of gp130 extracellular domain with Fc region and the resulting dimerization - to achieve high affinity binding (KD in low nM range) and extended half-life (approximately 2 days). These parameter optimizations enhance therapeutic efficacy while the human sequence identity (≥90%) maintains low immunogenicity, resolving the contradiction between efficacy and safety.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If sgp130 is used as trans-signalling inhibitor, then IL-6 trans-signalling is blocked, but binding affinity is low

Engineering Contradiction:
Improvebinding affinityVSAvoidhalf-life
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The gp130-Fc dimer combines the IL-6/sIL-6R binding domain of gp130 with the Fc region that provides dimerization and FcRn-mediated recycling. This composite structure achieves both high binding affinity (through the gp130 extracellular domain) and extended half-life (through dimerization and FcRn interaction), overcoming the limitations of monomeric sgp130.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent merges two functional elements: the IL-6/sIL-6R complex-binding capability of gp130 extracellular domain and the half-life extending capability of Fc dimerization. This merging creates a single molecule that simultaneously achieves high affinity binding and prolonged circulation, with the dimer structure providing both structural stability and extended pharmacokinetics.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP3912636B1Administration of a selective il-6-trans-signalling inhibitor
Publication Date: 2026.02.11 FERRING BV
  • EP3912636B1 patent drawingFigure 1
  • EP3912636B1 patent drawingFigure 2
  • EP3912636B1 patent drawingFigure 3

AI summary

A selective IL-6-trans-signalling inhibitor can be used to treat a variety of IL-6-mediated conditions, including inflammatory diseases and cancer. The inhibitor can safely be administered to humans at a variety of doses. Moreover, the inhibitor lessens deleterious effects associated with other IL-6 inhibitors such as lowering neutrophil counts, platelet counts and levels of C-reactive protein.