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FDA Grants Orphan Drug Designation to Masked Immunocytokine QXL138AM for MM


The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to QXL138AM for the treatment of multiple myeloma (MM).

QXL138AM, manufactured by a drug by Nammi Therapeutics, Inc., is a masked immunocytokine comprised of a CD138-targeted antibody fused with interferon alpha (IFNα) that is masked with a tumor-selectively releasable peptide. Once it is bound to the tumor cell, proteases on the tumor cell surface cleave the mask off the IFNα allowing it to bind its receptor, inducing direct killing of myeloma cells as well as activating innate and adaptive anti-tumor immunity.

The target of the drug, CD138, is a transmembrane proteoglycan known to be expressed in MM.

Nammi Therapeutics expects to file an investigational new drug application with the FDA to allow initiation of clinical studies this year.

Source: Nammi Therapeutics Press Release, June 2022

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