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isatuximab (Sanofi)
- Development stage
- Approved
- Lead developer
- Sanofi
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Subcutaneous
01
Overview
Isatuximab SC is a subcutaneous formulation of the CD38-directed monoclonal antibody isatuximab (Sarclisa), developed by Sanofi for the treatment of multiple myeloma. Isatuximab is a chimeric IgG1 antibody that binds to a specific extracellular epitope of the CD38 receptor, which is highly and uniformly expressed on multiple myeloma cells. Its mechanism of action includes antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), complement-dependent cytotoxicity (CDC), and the direct induction of apoptosis. Additionally, isatuximab inhibits the enzymatic activity of CD38, which is involved in calcium signaling and nucleotide metabolism. The subcutaneous formulation utilizes Halozyme's ENHANZE technology, incorporating recombinant human hyaluronidase PH20 (rHuPH20) to temporarily degrade hyaluronan in the subcutaneous space, allowing for the delivery of large volumes of the drug. This formulation aims to reduce administration time and treatment burden compared to the standard intravenous infusion. In 2024, Sanofi reported positive Phase 3 results from the IRAKLIA trial and submitted regulatory applications for the SC formulation.
- Brand names
- Sarclisa
- Other names
- isatuximab SCisatuximab subcutaneousisatuximab-irfc
02
Targets
CD38 (Cluster of Differentiation 38)
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