Anti-CD19 Antibody - Pipeline Insight, 2025

This “Anti-CD19 Antibody - Pipeline Insight, 2025” report provides comprehensive insights about 12+ companies and 12+ pipeline drugs in Anti-CD19 Antibody pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Anti-CD19 Antibody: Understanding

Anti-CD19 Antibody: Overview

Human Immune system is comprised of variety of immune cells which can be differentiated through the presence of cell surface CD molecules. These surface receptor molecules are commonly used as cell markers in immunophenotyping. CD molecules are associated with the immune function of the cell and belong to cluster of differentiation (CD) system. Cluster of differentiation 19 (CD19) is one of such cell surface molecule expressed on B- lineage cells and follicular dendritic cells. CD19 is expressed throughout B-cell development and plays a critical role in maintaining the balance between humoral, antigen-induced immune response and tolerance induction.

The human CD19 antigen is a 95- kDa transmembrane glycoprotein which belongs to the immunoglobulin (Ig) superfamily and is present on progenitor B cells, naïve and memory B cells, as well as on plasma blasts, but not on terminally differentiated plasma cells. The protein is encoded by the cd19 gene located on the short arm of chromosome 16 at band p11.2, contains 15 exons and 18 introns, spanning 7.59 kb of DNA and codes for the CD19 molecule with 556 amino acids.

Evaluation of anti-CD19 therapy as a therapeutic option requires a careful consideration of CD19 expression levels. CD19 expression is essential for B cell biology, along with an appropriate expression plays a critical role in their developmental process. CD19 is expressed three times higher in mature B cells than in immature B cells.

CD19 functions an essential regulator in both intrinsic and antigen receptor-induced B-cell signal transduction. CD19 is essential for primary B-cell activation by T-cell-dependent antigens as well as the differentiation into memory B cells. This receptor acts as a biomarker for normal and neoplastic B cells, as well as follicular dendritic cells including some early B-cell malignancies that do not express CD20. Considering, the biology and broad expression pattern of CD19 antigen, it is an ideal target for immunotherapy of B-cell malignancies. Here, other surface molecules such as CD27, CD38 and CD138 do not qualify as therapeutic targets for global B-cell depletion approaches, as these are not continuously expressed throughout B-cell differentiation and their expression is shared with other cells, for example, T lymphocytes and endothelial cells.

“Anti-CD19 Antibody - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the mechanism of action. A detailed picture of the Anti-CD19 Antibody pipeline landscape is provided which includes the disease overview and Anti-CD19 Antibody treatment guidelines. The assessment part of the report embraces, in depth Anti-CD19 Antibody commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Anti-CD19 Antibody collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Anti-CD19 Antibody R&D. The therapies under development are focused on novel approaches to treat/improve Anti-CD19 Antibody.

Anti-CD19 Antibody Emerging Drugs Chapters

This segment of the Anti-CD19 Antibody report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Anti-CD19 Antibody Emerging Drugs

Obexelimab : Zenas BioPharma

Obexelimab (XmAb5871) is a monoclonal antibody that targets CD19 with its variable domain and uses Xencor's XmAb immune inhibitor Fc domain to target FcγRIIb, a receptor that inhibits B-cell function. XmAb5871 is the first drug candidate that Xencor is aware of that targets FcγRIIb inhibition. Obexelimab’s highly potent and broad blockade of B-cell activation without depleting B cells differentiates it from other B-cell targeting therapies and has potential for treating many autoimmune diseases. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Warm Autoimmune Hemolytic Anemia and IgG4 Related Disease. The drug is also being developed for the treatment of Multiple Sclerosis and Systemic lupus erythematosus.

IKS 03: Iksuda Therapeutics

IKS-03 is a CD19-targeted antibody drug conjugate (ADC) under development by Iksuda Therapeutics. IKS-03 is designed to target CD19, a B-lymphocyte antigen, using a proprietary DNA-crosslinking PBD prodrug payload. This payload induces DNA crosslinking and blocks DNA replication, leading to cell death. Currently, the drug is in the Phase I stage of clinical trial evaluation for the treatment of B Cell Non-Hodgkin Lymphomas.

Anti-CD19 Antibody: Therapeutic Assessment

This segment of the report provides insights about the different Anti-CD19 Antibody drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Anti-CD19 Antibody

There are approx. 12+ key companies which are developing the therapies for Anti-CD19 Antibody. The companies which have their Anti-CD19 Antibody drug candidates in the most advanced stage, i.e. Phase III include, Zenas BioPharma.

Phases

The report covers around 12+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Anti-CD19 Antibody pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Anti-CD19 Antibody: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Anti-CD19 Antibody therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Anti-CD19 Antibody drugs.

Anti-CD19 Antibody Report Insights

• Anti-CD19 Antibody Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Anti-CD19 Antibody Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Anti-CD19 Antibody drugs?
• How many Anti-CD19 Antibody drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Anti-CD19 Antibody?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Anti-CD19 Antibody therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Anti-CD19 Antibody and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Zenas BioPharma
• Iksuda Therapeutics
• Amgen
• GENERIUM Pharmaceuticals
• Roche

Key Products

• Obexelimab
• IKS 03
• Inebilizumab
• GNR-084
• RO 7227166

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