Anti-cd19 Antibody Composition and Method

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This patent describes a method for producing a human or humanized anti-CD19 antibody with improved antibody-dependent cellular cytotoxicity (ADCC). By expressing the antibody in mammalian cells that also produce the enzyme GnTIII, the antibody's structure is modified at specific glycosylation sites to increase certain sugar residues (N-acetylglucosamine bisecting oligosaccharides, with a lower level of fucosylation). This structural change enhances the antibody's ability to trigger immune cell-mediated destruction of target cells, primarily B cells expressing CD19. The invention covers the method, the resulting antibody, and its pharmaceutical use, especially for treatment of cancers such as leukemias and lymphomas, as well as autoimmune diseases.

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• Therapeutic treatment of cancers involving malignant B cells, such as chronic lymphocytic leukemia, Non-Hodgkin lymphoma, and acute lymphoblastic leukemia.
• Treatment of autoimmune diseases like multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus (SLE).
• Development of more effective anti-CD19 antibody therapeutics for use in oncology and immunology.
• Potential application in combination therapies with other cancer treatments, including chemotherapeutic drugs or radiotherapy.
• Research models to study enhanced ADCC effects in antibody drugs.

BenefitsContent extracted from patent full text and abstract with AI.

• Greatly enhanced antibody-dependent cellular cytotoxicity (ADCC), making the antibody more effective at recruiting immune cells to destroy malignant or unwanted B cells.
• Increased specificity and potency of anti-CD19 antibody therapeutics, potentially improving treatment outcomes for patients with B-cell malignancies or autoimmune diseases.
• Use of human or humanized antibodies reduces the risk of immunogenic reactions in patients.
• Modified glycosylation (high bisected, low fucosylated) is achieved by a robust manufacturing process compatible with existing mammalian cell production systems.
• Potential for lower dosage and/or less frequent administration due to enhanced efficacy, which may reduce treatment side-effects.
• Enables the development of new pharmaceutical compositions for patient populations who are not responsive to existing anti-CD20 therapies.

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Inventors & Applicants

Patent Abstract

A method of enhancing the antibody-dependent cellular cytotoxicity (ADCC) of a human or humanized CD19 antibody is disclosed. The antibody is produced in the presence of a beta.(1 ,4)-N-acetylglucosaminyltransferase III (GnTIII) enzyme, under conditions effective to produce in the antibody, an Fc fragment characterized by Asn297-linked oligosaccharides containing (i) at least 60% N-acetylglucosamine bisecting oligosasccharides, and (ii) at least 10% non- fucosylated N-acetylglucosamine bisecting oligosaccharides. Also disclosed is an anti-CD19 antibody, a composition produced by the method, a treatment method for cancers associated with malignant B- lineage cells, such as chronic lymphocytic leukemia, Non-Hodgkin lymphoma, and acute lymphoblastic leukemia, and a treatment method for autoimmune disease.