Drug intelligence / Profile preview

siplizumab

Development stage
Phase 2
Lead developer
ITBMed Biopharmaceuticals
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Siplizumab is a humanized monoclonal immunoglobulin G1 (IgG1) antibody that targets the CD2 glycoprotein expressed on virtually all mature human T cells and most thymocytes, as well as natural killer (NK) cells. By binding to CD2, siplizumab induces depletion of CD2-positive cells through antibody-dependent cell-mediated cytotoxicity (ADCC), leading to selective suppression of the immune system. This mechanism results in lysis of malignant or activated T cells and NK cells, making it a potential therapy for conditions involving aberrant or overactive T-cell populations such as certain lymphomas, autoimmune diseases, and in transplantation settings to prevent rejection or induce tolerance. Siplizumab has been investigated for use in hematopoietic cell transplantation conditioning regimens and tolerance induction with combined kidney-bone marrow transplantation. It has also been studied for amyotrophic lateral sclerosis (ALS), liver transplant rejection, renal transplant rejection, type 1 diabetes mellitus, graft-versus-host disease (GVHD), hidradenitis suppurativa (preclinical), psoriasis (discontinued), psoriatic arthritis (discontinued), rheumatoid arthritis (discontinued), and T-cell lymphoma (discontinued). The drug was originally developed by Catholic University of Louvain and Ossium Health; development has involved BioTransplant, MedImmune, ITBMed Biopharmaceuticals—a subsidiary of Zelarion[3][5][8][1].

Brand names
Zelarion
Other names
siplizumab
02

Targets

CD2 (T-cell Surface Antigen CD2)

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