On June 13, 2022 Nammi Therapeutics, Inc. (Nammi), an LA-based immunotherapy company, reported that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of multiple myeloma (Press release, Nammi Therapeutics, JUN 13, 2022, View Source [SID1234615948]).
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QXL138AM is a Masked Immunocytokine (MIC) that targets a masked interferon alpha (IFNα) to the CD138 protein on the surface of the tumor cells. Once bound to the tumor cell, proteases on the tumor cell surface cleave the mask off the IFNα allowing it to bind its receptor. Activation of the IFNAR complex induces direct killing of myeloma cells as well as activating innate and adaptive anti-tumor immunity.
Multiple Myeloma is a relatively rare form of cancer, with the American Cancer Society estimating over 34,000 new cases and 12,000 deaths from multiple myeloma this year. While therapeutics have extended survival, it remains largely incurable. IFNα based therapeutics have demonstrated anti-tumor activity in clinical studies but are infrequently used due to significant toxicities. QXL138AM directly addresses this toxicity issue by targeting the IFNα to the myeloma cells with an anti-CD138 antibody and by masking the IFNα activity until it gets to the tumor.
About QXL138AM
QXL138AM is a first in class MIC comprised of a CD138-targeted antibody fused with Interferon alpha (IFNα) that is masked with a tumor-selectively releasable peptide. CD138 is expressed in multiple myeloma as well as many different solid tumor indications including pancreatic, breast, colon, hepatic, ovarian, urothelial, and head and neck cancers. Nammi Therapeutics is expecting to file an Investigational New Drug (IND) application with the FDA to allow initiation of clinical studies this year.