Cancer research advances at Orano Med
Since 2009, Orano Med has been working to advance cancer research and since 2015 has been committed to developing a treatment for neuroendocrine tumors.
After two clinical trials (the second - that of AlphaMedixTM - is still in progress), the nuclear medicine subsidiary of the Orano group reached
an important milestone in November 2018 by obtaining "orphan drug designation" for AlphaMedixTM from the US Food and Drug Administration (FDA). "The FDA's decision to grant orphan drug status is an important regulatory step for AlphaMedixTM, a key program in our pipeline of 212Pb-labeled compounds," underlines Julien Dodet, CEO of Orano Med. "We believe that 212Pb targeted alpha therapy represents a promising new approach and that AlphaMedixTM could have a significant impact for patients".
Targeted alpha therapy is an innovative therapeutic approach that makes it possible to recognize and destroy cancer cells while limiting the
impact on surrounding healthy cells. AlphaMedixTM, is an example of targeted alpha therapy for neuroendocrine tumors developed by Orano Med and RadioMedix using Orano Med's expertise to extract high purity lead-212 (212Pb).
What is an orphan drug?
A drug is said to be "orphan" when it addresses a small patient population. This designation, granted in the United States by the FDA's Office of Orphan Medicinal Products, is an incentive mechanism for continuing research into the development of safe and effective drugs for diseases affecting fewer than 200,000 people in the United States.
New projects to advance research
Combining biothechnologies and nuclear technology, Orano Med is now developing its own molecules, 212Pb-labeled peptides, which can target and destroy cancer cells. Since August 2018, Orano Med also counts among its partners Cellectar Biosciences, a biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer. This collaboration will focus on the development of novel phospholipid drug conjugates (PDC™) utilizing Orano Med’s unique alpha emitter, lead-212 (212Pb), conjugated to Cellectar’s phospholipid ether (PLE).
Moreover, to increase lead-212 production capacity and scale up its resources dimensioned for producing clinical doses, Orano Med has launched two expansion projects, one in France at the Maurice Tubiana laboratory and the other at DDPU in Plano Texas, USA.
It is at the Maurice Tubiana laboratory, in Bessines-sur-Gartempe in the Haute-Vienne (France), a facility unparalleled anywhere in the world, that Orano Med extracts the high-purity 212Pb it needs for preclinical and clinical trials of new
cancer treatments.
The DDPU (Domestic Distribution and Purification Unit) laboratory, located in Plano, Texas (United States), is fully-dedicated to the development of new 212Pb therapies and the production of lead-212. The
site also serves as the headquarters to Orano Med in the United States. It houses the laboratories and offices of its subsidiary Macrocyclics.
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