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# Orphan Status for Lymphoma Therapy
- URL: https://www.fdaweb.com/orphan-status-for-lymphoma-therapy/
- Published: 2023-11-15T12:00:00.000Z
- Updated: 2026-09-14T14:16:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155795

FDA has granted SIRPant Immunotherapeutics an orphan drug designation for SIRPant-M, an autologous macrophage therapy for treating T-cell lymphoma. “Unlike B-cell lymphomas and classical Hodgkin Lymphoma, many T-cell lymphoma subtypes do not have a suitable drug target, and approved cellular immuno-therapy is currently unavailable in T-cell lymphoma,” the company says. “With its unique polyclonal mechanism of action, relying on tumor-specific neo-antigens, SIRPant-M is well positioned to reveal the therapeutic potential of macrophage cell therapy in our recently opened clinical trial.”

T-cell lymphoma is a group of rare blood cancers classified under non-Hodgkin’s lymphoma and affect T-lymphocytes, which are critical to the immune system, according to the company. It is currently uncurable and starts in the skin and often causes skin redness, rashes, and tumors.

“As a monotherapy or in combination with other immuno-stimulatory modalities such as radiotherapy and immune checkpoint inhibitors, SIRPant-M acts by directly attacking cancerous cells, stimulating cancer neoantigen-specific cytotoxic T cells and antibodies, reducing immunosuppressive elements, and perpetuating a pro-inflammatory tumor microenvironment that favors cancer elimination,” the company says.