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SIRPant Immunotherapeutics Cleared to Begin Phase I Trial of Autologous Macrophage Therapy

NEW YORK – SIRPant Immunotherapeutics on Tuesday said it has been cleared by the US Food and Drug Administration to begin a Phase I trial of its lead product candidate, SIRPant-M, an autologous activated macrophage therapy, in solid tumors.

The Hummelstown, Pennsylvania-based firm will enroll patients with head and neck cancer, non-melanoma skin cancer, bladder cancer, kidney cancer, low-grade prostate cancer, triple-negative breast cancer, and certain sarcomas. Researchers will evaluate SIRPant-M as a monotherapy and in combination with other immuno-stimulatory modalities including a radiotherapy and immune checkpoint inhibitors.

"A unique attribute of this IND is that it allows SIRPant-M to be evaluated, in parallel, in both relapsed or refractory and preoperative settings earlier in the disease trajectory," SIRPant Chief Medical Officer Jelle Kijlstra said in a statement. "Exploring SIRPant-M in multiple therapeutic settings, in parallel rather than in sequence, allows for more expedient development as it enables us to establish more rapidly where this therapy has the highest potential in changing the lives of cancer patients."

SIRPant-M is designed to activate patients' own macrophages to recognize and eliminate cancerous cells by removing the signal regulatory protein alpha (SIRPα) functions on macrophages, which inhibit immune response. SIRPant developed the treatment using its PhagoAct platform.

In November, the FDA granted orphan drug designation to SIRPant-M as an investigational treatment of T-cell lymphoma. The agency also cleared the firm to begin a separate trial of SIRPant-M in non-Hodgkin lymphoma earlier this year.