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IASO-782 Injection is a fully human monoclonal antibody used for treating autoimmune haematological disorders. Credit: peterschreiber.media /Shutterstock.com.

The US Food and Drug Administration (FDA) has granted clearance to IASO Biotechnology’s investigational new drug (IND) application, initiating clinical trials in the US of an IASO-782 injection for autoimmune haematological disorders.

A fully human monoclonal antibody, IASO-782 is designed for treating haematological disorders including warm autoimmune haemolytic anaemia (wAIHA) and primary immune thrombocytopenia (ITP).

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The injection targets human CD19 and depletes CD19+ B cells, plasmablast cells, and some plasma cells thereby reducing or eliminating auto-reactive antibodies produced by these cells.

It also enhances ADCC function by targeting Fc mutations while keeping other Fc functions untouched (ADCP, CDC, FcRn binding et al.).

IASO is also engaged in developing multiple autologous and allogeneic CAR-T and biologics product candidates including Equecabtagene Autoleucel (CT103A), a fully human BCMA CAR-T injection.

It utilises proprietary manufacturing processes, a high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, as well as a fully human antibody discovery platform (IMARS).

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In addition to IASO-782 IND approval, IASO’s in-house developed CT103A for relapsed/refractory multiple myeloma (RRMM) received FDA approval for clinical trials.

A fully human CD19/CD22 dual-targeted CAR-T cell therapy is also an in-house developed candidate used for relapsed/refractory acute B-lymphoblastic leukaemia (r/r B-ALL).

It is also used for the treatment of relapsed/refractory B-cell non-Hodgkin’s lymphoma (r/r B-NHL), which is currently in Phase I clinical trial.

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