Ublituximab API Manufacturers

General Description:

Ublituximab, identified by CAS number 1174014-05-1, is a notable compound with significant therapeutic applications. CD20, an antigen expressed by various B and T cells, is an attractive therapeutic target in various cancers and autoimmune conditions. Monoclonal antibodies for B cell depletion rely on their binding affinity and ability to clear bound cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), mediated by interactions between an antibody and Fcγ receptors on natural killer cells or macrophages. Ublituximab is a chimeric anti-CD20 IgG1κ antibody produced in the rat YB2/0 cell line to target a unique epitope and enhance ADCC compared to other approved anti-CD20 antibodies such as , , , and . Ublituximab was initially developed by LFB Group but was licensed to TG Therapeutics in 2012. It has been investigated for use in numerous B cell-dependent conditions, including chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and relapsing multiple sclerosis.

Indications:

This drug is primarily indicated for: Ublituximab is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Half-life:

The half-life of Ublituximab is an important consideration for its dosing schedule: The estimated mean terminal half-life of ublituximab-xiiy was 22 days. This determines the duration of action and helps in formulating effective dosing regimens.

Volume of Distribution:

Ublituximab is distributed throughout the body with a volume of distribution of: The estimated central volume of distribution of ublituximab-xiiy was 3.18 L. This metric indicates how extensively the drug permeates into body tissues.

Mechanism of Action:

Ublituximab functions by: B cell dysregulation underlies the pathogenesis of various cancers and autoimmune conditions such as multiple sclerosis, neuromyelitis optica spectrum disease, and myelin oligodendrocyte glycoprotein IgG-associated disease. CD20 is an antigen expressed on pre-B cells, immature/mature B cells, memory B cells, and a subpopulation of CD3-positive T cells. Anti-CD20 antibodies can therefore induce B cell depletion through direct cell death, induction of complement pathways, and Fc-gamma receptor (FcγR)-mediated phagocytosis (antibody-dependent cellular cytotoxicity, ADCC). Although several anti-CD20 antibodies have been developed, therapy has been hampered by low CD20 expression by malignant cells in diseases such as B cell chronic lymphocytic leukemia and suboptimal antibody-dependent cytotoxicity. Ublituximab binds to an epitope on CD20 distinct from that bound by other approved antibodies such as , , , and , with a similar binding constant to . Uniquely, ublituximab is produced in the rat YB2/0 cell line such that it has a low fucose content (24% compared to 93% for ), improving its interaction with FcγR, especially FcγRIIIA (CD16) expressed by natural killer cells and macrophages. This difference grants ublituximab enhanced ADCC, including for low CD20-expressing malignant cells. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Classification:

Ublituximab belongs to the None, classified under the direct parent group Peptides. This compound is a part of the Organic Compounds, falling under the Organic Acids superclass, and categorized within the Carboxylic Acids and Derivatives class, specifically within the Amino Acids, Peptides, and Analogues subclass.

Categories:

Ublituximab is categorized under the following therapeutic classes: Amino Acids, Peptides, and Proteins, Antibodies, Blood Proteins, Globulins, Immunoglobulins, Immunoproteins, Leukemia, Lymphocytic, Chronic, B-Cell, drug therapy, Proteins, Serum Globulins. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.