Nammi Therapeutics, Inc. (Nammi), a Los Angeles based immunotherapy company, announced that the FDA has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of Pancreatic Cancer. Nammi has previously received ODD for QXL138AM for treatment of multiple myeloma.
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 Pancreatic tumor cells as well as activating innate and adaptive anti-tumor immunity.
Pancreatic Cancer is a relatively rare form of cancer, with the American Cancer Society estimating over 62,210 new cases and 49,830 deaths from Pancreatic Cancer this year. Surgical removal is the only potentially curative treatment known and 80% of patients present with advanced disease that do not benefit from surgery. 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 tumor cells with an anti-CD138 antibody and by masking the IFNα activity until it gets to the tumor.
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