Biosion’s SIRPα-Targeting Monoclonal Antibody BSI-082 Clears US FDA Clinical Trial Hurdle

Biosion, a global clinical-stage biotechnology company dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its pipeline candidate BSI-082. This monoclonal antibody (mAb) targets SIRPα and is under development for the treatment of various blood cancers and solid tumors.

BSI-082 demonstrates strong binding activity for huSIRP α variants V1/V2/V8, covering over 90% of the population. The antibody specifically binds to SIRP α and SIRP β, but not SIRP γ, effectively blocking the interaction between SIRP α and CD47. This blockade interrupts the “don’t eat me” signal sent to macrophages, enabling them and dendritic cells to resume their phagocytic activity against tumor cells while avoiding potential toxic side-effects associated with targeted CD47 therapy. BSI-082 has shown strong in vivo anti-tumor effects when combined with monoclonal antibodies against tumor-associated antigens in various animal models.- Flcube.com

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