Cellectar Biosciences, Inc., a late-stage clinical biopharmaceutical company, has announced a strategic partnership with City of Hope Cancer Center, one of the largest cancer research and treatment organizations in the United States. This collaboration focuses on the clinical development of Cellectar’s lead radioconjugate asset, iopofosine I 131, for the treatment of mycosis fungoides (MF), a rare form of non-Hodgkin’s lymphoma (NHL) that primarily affects the skin and, in some cases, internal organs and blood.
Iopofosine is the first systemic targeted radiotherapeutic to be assessed for cutaneous T-cell lymphomas (CTCL). The investigator-sponsored trial will evaluate approximately 10 patients, with initiation planned for late 2024 or early 2025. Dr. Steven T. Rosen of City of Hope highlighted the potential advantages of iopofosine over conventional external beam radiotherapy, noting its unique delivery platform that targets all tumor sites with systemic delivery, potentially reducing the risk of systemic progression or transformation.
Mycosis fungoides, the most common form of CTCL, affects approximately 30,000 patients in the U.S. and currently has no curable treatment options. The disease is characterized by skin rash, plaques, and tumors, leading to disfigurement and severe pruritis, with some cases involving blood and internal organs that may lead to death.
The U.S. Food and Drug Administration (FDA) has granted iopofosine I 131 Orphan Drug and Fast Track Designation for several conditions, including relapsed/refractory Waldenstrom's macroglobulinemia, multiple myeloma, and diffuse large B-cell lymphoma. Cellectar is preparing to submit a New Drug Application (NDA) to the FDA based on its CLOVER WaM pivotal study in Waldenstrom's macroglobulinemia in the second half of 2024.
This partnership underscores the potential of iopofosine as a transformative treatment for patients with mycosis fungoides and other cancers, offering hope for those with limited treatment options.
