Subject: FDA
Nammi Therapeutics Granted FDA Orphan Drug Designation For QXL138AM for the Treatment of Multiple Myeloma
LOS ANGELES , June 13, 2022 /PRNewswire/ -- Nammi Therapeutics, Inc. (Nammi), an LA-based immunotherapy company, announced today 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.
QXL138AM is a Masked Immunocytokine (MIC) that targets a masked interferon alpha (IFN?) 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 IFN? 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. IFN? 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 IFN? to the myeloma cells with an anti-CD138 antibody and by masking the IFN? activity until it gets to the tumor.
QXL138AM is a first in class MIC comprised of a CD138-targeted antibody fused with Interferon alpha (IFN?) 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.
Nammi Therapeutics, Inc. is an immuno-oncology company based in Los Angeles that is developing platforms and products that selectively activate anti-tumor immunity within the tumor microenvironment while minimizing systemic activation. By reducing systemic activation of the immune system, Nammi expects to improve safety and enhance the ability to combine multiple immune modulators. In addition to the MIC platform, Nammi has also developed a nanoparticle platform to deliver Immune Modulating Prodrugs (IMPs) using their Nammisome technology. Multiple Nammisome clinical candidates have also been selected for development.
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SOURCE Nammi Therapeutics, Inc.
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SOURCE Nammi Therapeutics, Inc.
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