Invented by Hailing Hsu, Gunasekaran Kannan, Kenneth W. Walker, Michelle Hortter, Edward J. Belouski, Amgen Inc

The market for Anti-TL1A/Anti-TNF-alpha bispecific antigen binding proteins and uses thereof is witnessing significant growth due to the increasing prevalence of autoimmune diseases and the need for more effective treatment options. These bispecific antigen binding proteins hold immense potential in revolutionizing the field of immunotherapy and improving patient outcomes. Autoimmune diseases, characterized by an abnormal immune response against the body’s own tissues, affect millions of people worldwide. Conditions such as rheumatoid arthritis, Crohn’s disease, psoriasis, and ulcerative colitis can cause chronic inflammation, pain, and disability. Current treatment options for these diseases often involve the use of anti-TNF-alpha monoclonal antibodies, which have shown efficacy in reducing inflammation and managing symptoms. However, a significant proportion of patients do not respond adequately to these therapies or develop resistance over time. This is where the emergence of Anti-TL1A/Anti-TNF-alpha bispecific antigen binding proteins comes into play. TL1A, also known as TNFSF15, is a cytokine that plays a crucial role in the regulation of immune responses. It has been identified as a potential target for the treatment of autoimmune diseases, as its overexpression has been observed in various inflammatory conditions. By simultaneously targeting both TL1A and TNF-alpha, these bispecific antigen binding proteins offer a dual mechanism of action, providing a more comprehensive approach to disease management. The market for these bispecific antigen binding proteins is expected to grow rapidly in the coming years, driven by several factors. Firstly, the increasing prevalence of autoimmune diseases globally is creating a significant demand for novel and more effective therapies. According to the American Autoimmune Related Diseases Association, approximately 50 million Americans suffer from autoimmune diseases, with the number expected to rise. This growing patient population presents a substantial market opportunity for Anti-TL1A/Anti-TNF-alpha bispecific antigen binding proteins. Secondly, the limitations of current treatment options, such as anti-TNF-alpha monoclonal antibodies, have created a need for alternative therapies. Many patients do not respond adequately to these drugs or experience adverse effects. Bispecific antigen binding proteins offer the potential for improved efficacy and reduced side effects, making them an attractive option for both patients and healthcare providers. Furthermore, advancements in biotechnology and protein engineering have facilitated the development of these novel therapeutics. Companies specializing in the production of bispecific antibodies have made significant progress in optimizing their design, stability, and manufacturing processes. This has led to the generation of highly specific and potent Anti-TL1A/Anti-TNF-alpha bispecific antigen binding proteins with improved pharmacokinetic properties. The potential applications of Anti-TL1A/Anti-TNF-alpha bispecific antigen binding proteins extend beyond autoimmune diseases. Preclinical studies have demonstrated their efficacy in other inflammatory conditions, such as asthma, multiple sclerosis, and inflammatory bowel disease. This broadens the market potential for these therapeutics, as they could be utilized in various therapeutic areas. In conclusion, the market for Anti-TL1A/Anti-TNF-alpha bispecific antigen binding proteins and their uses in the treatment of autoimmune diseases and other inflammatory conditions is poised for significant growth. With the increasing prevalence of these diseases and the need for more effective therapies, these bispecific antibodies offer a promising solution. Continued research and development efforts, along with regulatory approvals, will be crucial in unlocking the full potential of these innovative therapeutics and improving the lives of patients worldwide.

The Amgen Inc invention works as follows

The present invention relates to antigen-binding proteins that bind TL1A. This includes bispecific antigen-binding proteins (e.g. antibodies) directed at TL1A as well as TNF?. These bispecific antibodies may be in a tetrameric format of immunoglobulin, where one heavy chain/light chain pair is directed at TL1A while the other is directed at TNF-?. Bispecific antigen-binding proteins can also be found in IgG scFv, where a conventional tetrameric antigen directed towards one antigen is fused with a pair single chain Fv directed toward the other antigen. The bispecific binding protein can also be used in an IgG – Fab fusion. In this fusion, a Fab molecule which binds to a particular antigen is fused with each heavy chain in a conventional tetrameric antigen directed to the opposite antigen. The invention also relates to the use of anti-TL1A-binding proteins and anti TL1A/anti TNF-? “Antigen binding proteins and pharmaceutical formulations of such proteins.

Background for Anti-tl1a/anti-tnf-alpha bispecific antigen binding proteins and uses thereof

Definition and Definition of Terms

The invention relates to “Bispecific antigen binding protein formats

Preferred Embodiments

TL1A-Specific Antigen Binding Proteins

Chain Mutations

Binding affinity and biological activity

Immunoconjugates, Derivatives, Variants

Nucleic Acids, Vectors, Host Cells

Purification

Uses of the Monospecific and Bispecific antibodies of the Invention

WORKING EXAMPLES

Example 1

Mouse Strains

Generation TL1A Immunogen

Example 2

Generation TL1A

Immunizations

Example 3

Preparation Monoclonal Antibodies

Hybridoma Generation

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