Phanes Therapeutics’ First-in-Class BsAb PT217 Accepted for Review by China’s CDE

Sino-US biotechnology company Phanes Therapeutics Inc. has announced that the Investigational New Drug (IND) filing for its potential first-in-class in-house bispecific antibody (BsAb) PT217 has been accepted for review by China’s Center for Drug Evaluation (CDE). PT217 is designed to directly kill tumor cells through the antibody-dependent cellular phagocytosis (ADCP) activity of macrophages and the antibody-dependent cellular cytotoxicity (ADCC) activity of natural killer (NK) cells. It targets the overexpressed DLL3 and CD47 on the surface of tumor cells, expanding the range of tumor killing.

Additionally, PT217 is anticipated to induce the presentation of tumor neoantigens by guiding tumor cells into phagocytic antigen-presenting cells (APCs), indirectly activating T cells to kill tumor cells with low or no DLL3 expression by recognizing tumor neoantigens, thus stimulating the acquired immune system. The anti-CD47 component of PT217 has shown high differentiation in preclinical models, maintaining strong binding activity with CD47 on tumor cells while minimizing binding to human red blood cells.

PT217 received clearance for a Phase I study in the US in 2022 and was awarded Orphan Drug Designation (ODD) status for the treatment of small-cell lung cancer by the US FDA the same year.- Flcube.com

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