isatuximab

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isatuximab

GtoPdb Ligand ID: 8719

isatuximab is an approved drug (EMA & FDA (2020))

Comment: Isatuximab is an anti-CD38 monoclonal antibody that was designed for anti-tumour potential [2].
A patent search identifies the peptide sequences of the light and heavy chain variable regions of isatuximab as SEQ ID NO: 22 and SEQ ID NO: 21 from patent US 8877899 B2 [6] (and equates to Ref mAB5 in the patent document). This patent further refers these sequences to WO2008047242 A8, but neither this or any associated patent (eg US20110262454 A1) provide peptide sequences to allow identification of isatuximab therein. The most likely patent defined embodiment being isatuximab is hu38SB19 [4].

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Summary of Clinical Use
Isatuximab has completed Phase 1-3 clinical trials for its potential to treat hematological malignancies [1-2,5]. It was granted FDA approval in early March 2020 [3] and EMA authorisation in May 2020. These approvals authorise isatuximab's use in combination with pomalidomide and dexamethasone in a defined set of patients with relapsed refractory multiple myeloma. Eligible patients must have received at least two prior therapies including lenalidomide and a protease inhibitor.

Summary of Clinical Use

Isatuximab has completed Phase 1-3 clinical trials for its potential to treat hematological malignancies [1-2,5]. It was granted FDA approval in early March 2020 [3] and EMA authorisation in May 2020. These approvals authorise isatuximab's use in combination with pomalidomide and dexamethasone in a defined set of patients with relapsed refractory multiple myeloma. Eligible patients must have received at least two prior therapies including lenalidomide and a protease inhibitor.

Mechanism Of Action and Pharmacodynamic Effects
CD38⁺ cells are present in diverse hematologic malignancies, including multiple myeloma, B-cell non-Hodgkin lymphoma (NHL), B-cell chronic lymphocytic leukemia, B-cell acute lymphoblastic leukemia (ALL), and T-cell ALL. CD38 is a validated molecular target for antineoplastic drug development for these indications. In preclinical experiments, anti-CD38 antibody isatuximab exhibits strong proapoptotic activity and potent effector functions (complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP)) [2].

Mechanism Of Action and Pharmacodynamic Effects

CD38⁺ cells are present in diverse hematologic malignancies, including multiple myeloma, B-cell non-Hodgkin lymphoma (NHL), B-cell chronic lymphocytic leukemia, B-cell acute lymphoblastic leukemia (ALL), and T-cell ALL. CD38 is a validated molecular target for antineoplastic drug development for these indications. In preclinical experiments, anti-CD38 antibody isatuximab exhibits strong proapoptotic activity and potent effector functions (complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP)) [2].