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Comprehensive Analysis of United States Patent 8,293,883: Engineered Anti-IL-23P19 Antibodies

Introduction

United States Patent 8,293,883, titled "Engineered anti-IL-23P19 antibodies," is a significant patent in the field of immunology and biotechnology. This patent, assigned to Janssen Biotech, Inc., pertains to the development and use of engineered antibodies targeting the p19 subunit of the interleukin-23 (IL-23) protein. Here, we will delve into the key claims, the patent landscape, and the implications of this technology.

Background of the Invention

IL-23 is a cytokine that plays a crucial role in the regulation of immune responses, particularly in the differentiation of naive T cells into Th17 cells. These cells are involved in various inflammatory and autoimmune diseases, such as psoriasis, rheumatoid arthritis, and inflammatory bowel disease. The patent addresses the need for therapeutic agents that can specifically target and modulate the IL-23 pathway to treat these conditions[1][2].

Key Claims of the Patent

The patent claims cover several aspects of the engineered anti-IL-23P19 antibodies:

Antibody Structure and Composition

The patent describes the engineering of antibodies that specifically bind to the p19 subunit of IL-23. These antibodies include various formats such as full-length antibodies, antibody fragments, and single-chain variable fragments (scFv). The claims also encompass modifications to the antibody structure to enhance binding affinity, stability, and pharmacokinetic properties[1].

Methods of Production

The patent outlines methods for producing these engineered antibodies, including recombinant DNA technology and cell-based expression systems. It also covers the use of nucleic acids encoding the antibodies and vectors for their expression[1].

Therapeutic Uses

The primary therapeutic use claimed is the treatment of inflammatory, autoimmune, and proliferative disorders. Specific conditions mentioned include psoriasis, rheumatoid arthritis, and inflammatory bowel disease. The patent also suggests potential applications in other diseases where IL-23 plays a pathogenic role[1].

Diagnostic and Research Applications

In addition to therapeutic uses, the patent claims the use of these antibodies in diagnostic assays and research tools. This includes their application in bioassays, ELISA, and other analytical methods to detect and quantify IL-23 levels[1].

Patent Landscape Analysis

Geographical Spread

The geographical spread of patents related to anti-IL-23 antibodies is predominantly in regions with significant biotechnology and pharmaceutical industries, such as the United States, Europe, and Japan. Companies like Janssen Biotech, Inc., and other major pharmaceutical firms have a strong presence in these regions, reflecting their investment in research and development in this area[3].

Saturation of the Patent Space

The patent space for anti-IL-23 antibodies is moderately saturated, with several key players holding significant patent portfolios. This saturation indicates a competitive landscape where new entrants must navigate existing patents to develop novel therapies. The patent landscape analysis helps in identifying underappreciated niche areas and potential opportunities for innovation[3].

New Entrants and Market Dynamics

New entrants into this patent space include biotechnology startups and smaller pharmaceutical companies. These entities often focus on developing novel antibody formats or targeting different aspects of the IL-23 pathway. The dynamic nature of this space is evident from the continuous filing of new patent applications and the evolution of existing technologies[3].

Time-Slicing and Trend Analysis

Time-slicing analysis reveals that the patent activity in this area has been increasing over the past decade, with a peak in filings around 2015-2017. This trend reflects the growing interest in IL-23 as a therapeutic target and the advancements in antibody engineering technologies. The analysis also shows a shift towards more specific and targeted therapies, indicating a maturation of the technology[3].

Strategic Insights

Competitor Analysis

Key competitors in this space include Janssen Biotech, Inc., AbbVie, and other major pharmaceutical companies. These companies have extensive patent portfolios and are actively involved in the development and commercialization of anti-IL-23 therapies. Understanding the competitive landscape is crucial for new entrants to identify gaps and opportunities[3].

Niche Areas and Opportunities

Despite the saturation, there are niche areas that remain underexplored. For example, the development of bispecific antibodies targeting both IL-23 and other cytokines involved in inflammatory pathways presents a promising area for innovation. Additionally, the application of anti-IL-23 antibodies in combination therapies offers another avenue for research and development[3].

Regulatory and Clinical Efficacy

The clinical efficacy of anti-IL-23 antibodies has been demonstrated in several trials, particularly for psoriasis. For instance, tildrakizumab, an anti-IL-23p19 antibody, has shown significant efficacy in treating moderate to severe plaque psoriasis[4].

"Approximately 40% of the subjects who developed antibodies to tildrakizumab had antibodies that were classified as neutralizing, but this did not appear to impact the efficacy of the treatment"[4].

Structural Basis and Clinical Correlations

Structural Analysis

Structural analysis, including crystallization and nuclear magnetic resonance, has been crucial in identifying sites critical for antibody binding. This information helps in designing antibodies with high affinity and specificity for the p19 subunit of IL-23[2].

Clinical Efficacy Correlations

The structural basis of differential p19 targeting by anti-IL-23 biologics correlates with short- and long-term clinical efficacy. Studies have shown that the specificity and affinity of these antibodies for the p19 subunit are key determinants of their therapeutic effectiveness[5].

Key Takeaways

Engineered Antibodies: The patent covers the development of engineered antibodies specifically targeting the p19 subunit of IL-23.
Therapeutic Applications: These antibodies are primarily used for treating inflammatory, autoimmune, and proliferative disorders.
Patent Landscape: The patent space is moderately saturated with key players holding significant portfolios, indicating a competitive landscape.
Strategic Insights: Understanding the competitive landscape, identifying niche areas, and analyzing time-slicing trends are crucial for strategic decision-making.
Clinical Efficacy: The clinical efficacy of these antibodies has been demonstrated, particularly in the treatment of psoriasis.

FAQs

What is the primary therapeutic target of the engineered antibodies described in US Patent 8,293,883?

The primary therapeutic target is the p19 subunit of the interleukin-23 (IL-23) protein.

What are the main conditions treated by these antibodies?

The main conditions treated include psoriasis, rheumatoid arthritis, and inflammatory bowel disease.

How are these antibodies produced?

These antibodies are produced using recombinant DNA technology and cell-based expression systems.

What is the significance of structural analysis in the development of these antibodies?

Structural analysis helps in identifying sites critical for antibody binding, enabling the design of high-affinity and specific antibodies.

What are some niche areas for innovation in the anti-IL-23 antibody space?

Niche areas include the development of bispecific antibodies and the application of anti-IL-23 antibodies in combination therapies.

Sources

US8293883B2 - Engineered anti-IL-23P19 antibodies - Google Patents
US9714287B2 - ANTI-IL-23 ANTIBODY COMPOSITIONS - Google Patents
Patent Landscape Analysis - Uncovering Strategic Insights - AcclaimIP
ILUMYA (tildrakizumab-asmn) Label - FDA
Structural Basis for Differential p19 Targeting by Anti-IL-23 Biologics - ResearchGate

Title:	Engineered anti-IL-23P19 antibodies
Abstract:	Engineered antibodies to human IL-23p19 are provided, as well as uses thereof, e.g., in treatment of inflammatory, autoimmune, and proliferative disorders.
Inventor(s):	Presta Leonard G.
Assignee:	Schering Corporation
Application Number:	US12526543
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Comprehensive Analysis of United States Patent 8,293,883: Engineered Anti-IL-23P19 Antibodies Introduction United States Patent 8,293,883, titled "Engineered anti-IL-23P19 antibodies," is a significant patent in the field of immunology and biotechnology. This patent, assigned to Janssen Biotech, Inc., pertains to the development and use of engineered antibodies targeting the p19 subunit of the interleukin-23 (IL-23) protein. Here, we will delve into the key claims, the patent landscape, and the implications of this technology. Background of the Invention IL-23 is a cytokine that plays a crucial role in the regulation of immune responses, particularly in the differentiation of naive T cells into Th17 cells. These cells are involved in various inflammatory and autoimmune diseases, such as psoriasis, rheumatoid arthritis, and inflammatory bowel disease. The patent addresses the need for therapeutic agents that can specifically target and modulate the IL-23 pathway to treat these conditions[1][2]. Key Claims of the Patent The patent claims cover several aspects of the engineered anti-IL-23P19 antibodies: Antibody Structure and Composition The patent describes the engineering of antibodies that specifically bind to the p19 subunit of IL-23. These antibodies include various formats such as full-length antibodies, antibody fragments, and single-chain variable fragments (scFv). The claims also encompass modifications to the antibody structure to enhance binding affinity, stability, and pharmacokinetic properties[1]. Methods of Production The patent outlines methods for producing these engineered antibodies, including recombinant DNA technology and cell-based expression systems. It also covers the use of nucleic acids encoding the antibodies and vectors for their expression[1]. Therapeutic Uses The primary therapeutic use claimed is the treatment of inflammatory, autoimmune, and proliferative disorders. Specific conditions mentioned include psoriasis, rheumatoid arthritis, and inflammatory bowel disease. The patent also suggests potential applications in other diseases where IL-23 plays a pathogenic role[1]. Diagnostic and Research Applications In addition to therapeutic uses, the patent claims the use of these antibodies in diagnostic assays and research tools. This includes their application in bioassays, ELISA, and other analytical methods to detect and quantify IL-23 levels[1]. Patent Landscape Analysis Geographical Spread The geographical spread of patents related to anti-IL-23 antibodies is predominantly in regions with significant biotechnology and pharmaceutical industries, such as the United States, Europe, and Japan. Companies like Janssen Biotech, Inc., and other major pharmaceutical firms have a strong presence in these regions, reflecting their investment in research and development in this area[3]. Saturation of the Patent Space The patent space for anti-IL-23 antibodies is moderately saturated, with several key players holding significant patent portfolios. This saturation indicates a competitive landscape where new entrants must navigate existing patents to develop novel therapies. The patent landscape analysis helps in identifying underappreciated niche areas and potential opportunities for innovation[3]. New Entrants and Market Dynamics New entrants into this patent space include biotechnology startups and smaller pharmaceutical companies. These entities often focus on developing novel antibody formats or targeting different aspects of the IL-23 pathway. The dynamic nature of this space is evident from the continuous filing of new patent applications and the evolution of existing technologies[3]. Time-Slicing and Trend Analysis Time-slicing analysis reveals that the patent activity in this area has been increasing over the past decade, with a peak in filings around 2015-2017. This trend reflects the growing interest in IL-23 as a therapeutic target and the advancements in antibody engineering technologies. The analysis also shows a shift towards more specific and targeted therapies, indicating a maturation of the technology[3]. Strategic Insights Competitor Analysis Key competitors in this space include Janssen Biotech, Inc., AbbVie, and other major pharmaceutical companies. These companies have extensive patent portfolios and are actively involved in the development and commercialization of anti-IL-23 therapies. Understanding the competitive landscape is crucial for new entrants to identify gaps and opportunities[3]. Niche Areas and Opportunities Despite the saturation, there are niche areas that remain underexplored. For example, the development of bispecific antibodies targeting both IL-23 and other cytokines involved in inflammatory pathways presents a promising area for innovation. Additionally, the application of anti-IL-23 antibodies in combination therapies offers another avenue for research and development[3]. Regulatory and Clinical Efficacy The clinical efficacy of anti-IL-23 antibodies has been demonstrated in several trials, particularly for psoriasis. For instance, tildrakizumab, an anti-IL-23p19 antibody, has shown significant efficacy in treating moderate to severe plaque psoriasis[4]. "Approximately 40% of the subjects who developed antibodies to tildrakizumab had antibodies that were classified as neutralizing, but this did not appear to impact the efficacy of the treatment"[4]. Structural Basis and Clinical Correlations Structural Analysis Structural analysis, including crystallization and nuclear magnetic resonance, has been crucial in identifying sites critical for antibody binding. This information helps in designing antibodies with high affinity and specificity for the p19 subunit of IL-23[2]. Clinical Efficacy Correlations The structural basis of differential p19 targeting by anti-IL-23 biologics correlates with short- and long-term clinical efficacy. Studies have shown that the specificity and affinity of these antibodies for the p19 subunit are key determinants of their therapeutic effectiveness[5]. Key Takeaways Engineered Antibodies: The patent covers the development of engineered antibodies specifically targeting the p19 subunit of IL-23. Therapeutic Applications: These antibodies are primarily used for treating inflammatory, autoimmune, and proliferative disorders. Patent Landscape: The patent space is moderately saturated with key players holding significant portfolios, indicating a competitive landscape. Strategic Insights: Understanding the competitive landscape, identifying niche areas, and analyzing time-slicing trends are crucial for strategic decision-making. Clinical Efficacy: The clinical efficacy of these antibodies has been demonstrated, particularly in the treatment of psoriasis. FAQs What is the primary therapeutic target of the engineered antibodies described in US Patent 8,293,883? The primary therapeutic target is the p19 subunit of the interleukin-23 (IL-23) protein. What are the main conditions treated by these antibodies? The main conditions treated include psoriasis, rheumatoid arthritis, and inflammatory bowel disease. How are these antibodies produced? These antibodies are produced using recombinant DNA technology and cell-based expression systems. What is the significance of structural analysis in the development of these antibodies? Structural analysis helps in identifying sites critical for antibody binding, enabling the design of high-affinity and specific antibodies. What are some niche areas for innovation in the anti-IL-23 antibody space? Niche areas include the development of bispecific antibodies and the application of anti-IL-23 antibodies in combination therapies. Sources US8293883B2 - Engineered anti-IL-23P19 antibodies - Google Patents US9714287B2 - ANTI-IL-23 ANTIBODY COMPOSITIONS - Google Patents Patent Landscape Analysis - Uncovering Strategic Insights - AcclaimIP ILUMYA (tildrakizumab-asmn) Label - FDA Structural Basis for Differential p19 Targeting by Anti-IL-23 Biologics - ResearchGate More… ↓ ⤷ Try for Free

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate

Sun Pharmaceutical Industries Limited	ILUMYA	tildrakizumab-asmn	Injection	761067	March 20, 2018	8,293,883	2028-02-21
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 8,293,883

Summary for Patent: 8,293,883