Cellectar, Evergreen Enter Clinical Manufacturing and Supply Agreement

Cellectar Biosciences, a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, has entered into a commercial manufacturing and supply agreement with Evergreen Theragnostics, a global radiopharmaceutical contract development and manufacturing organization (CDMO) based in Springfield, NJ. The company also announced that the United States Adopted Names Council (USAN) has approved the use of “iopofosine I-131” as the generic name for CLR-131.
 
The agreement with Evergreen provides long term commercial supply of iopofosine I-131 and supply of clinical study material for Cellectar’s pivotal study in Waldenstrom’s macroglobulinemia (WM) as well as ongoing Phase 1 and Phase 2 clinical studies. Evergreen will conduct process development and validation of additional large scale commercial quantities of iopofosine I-131 at its newly constructed, state-of-the-art manufacturing facility designed specifically for radiopharmaceutical manufacturing, including therapeutic and diagnostic radiopharmaceuticals.
 
“Establishing a collaboration with a strong partner capable of supplying clinical and commercial scale quantities of iopofosine I-131 is another important advancement in our iopofosine I-131 product development and commercialization plan,” said James Caruso, president and CEO of Cellectar. “Evergreen has tremendous expertise as a leading radiopharmaceutical contract manufacturer, and their location in New Jersey provides strategic logistical advantages including favorable distribution for both the U.S. and ex-U.S. markets. Importantly, this collaboration expands upon our current supply capabilities with our existing CDMO, allows future development and supply of additional radiotherapeutic programs in development and continues to pave the way for Cellectar to meet the potential market demand for iopofosine I-131 upon approval.”
 
James Cook, CEO of Evergreen Theragnostics, said, “We welcome this new collaboration with Cellectar Biosciences. Iopofosine I-131 represents a unique and novel class of radiotherapeutics and Evergreen is excited to participate in its continued development and long-term supply to patients. We look forward to working with Cellectar on this and future programs.”
 
Iopofosine I-131 is currently being investigated in a global, pivotal expansion cohort in WM patients who have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitor failed or suboptimal response. The WM cohort will enroll up to 50 patients to evaluate the efficacy and safety of iopofosine I-131 for marketing approval. The company is also evaluating iopofosine I-131 in highly refractory multiple myeloma patients in its Phase 2 CLOVER-1 study in hematologic malignancies.