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Cellectar Announces Manufacturing and Supply Agreement with Evergreen Theragnostics for CLR-131, now known as iopofosine I-131
Evergreen to provide clinical and commercial supply of iopofosine I-131 (also known as CLR 131) Agreement adds second manufacturer and expands Cellectar’s
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"Evergreen to provide clinical and commercial supply of iopofosine I-131 (also known as CLR 131) Agreement adds second manufacturer and expands Cellectar’s current supply capabilities FLORHAM PARK, N.J., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that it 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 stated that, “We welcome this new collaboration with Cellectar Biosciences. Iopofosine I-131 represents a unique and novel class ...