On March 13, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported the signing of a Product Supply Agreement with the Idaho State University Idaho Accelerator Center (IAC) for the production and commercial supply of copper-67 (Cu-67) (Press release, Clarity Pharmaceuticals, MAR 13, 2020, View Source [SID1234555497]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the new agreement, IAC will supply Clarity with Cu-67 for planned clinical development, including the SARTATETM trial in children with neuroblastoma and SAR-bisPSMA trial in prostate cancer patients in the United States. IAC has been Clarity’s long-term partner, providing a reliable supply of high purity and high specific activity Cu-67 for some years. IAC’s proven experience in the production and supply of Cu-67 has already allowed Clarity to initiate and complete therapeutic studies in a range of cancer types both in the United States and in Australia.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to bolster our relationship with IAC to further progress our pipeline of theranostic agents in the fight against cancer. IAC’s electron accelerator capability enables Clarity to eliminate the reliance on supply from the limited number of aging nuclear reactors which currently produce therapeutic radionuclides such as lutetium-177. This gives Clarity the opportunity to move swiftly through clinical trials with its three main products, SARTATETM, SAR-bisPSMA and SAR-BBN in such indications as neuroblastoma, neuroendocrine tumours, prostate cancer, breast cancer and brain cancers.

"We are pleased to have signed the Product Supply Agreement with Clarity and are looking forward to continuing our supply of this copper isotope using our increased capacity and our world leading e-linac process to produce a high purity product at very high specific activity," said Jon Stoner, director of the IAC. "Clarity’s proprietary chelator technology along with our patent protected commercially produced Cu-67 combine to showcase a future market leading medical isotope."

Dr Taylor further commented, "Clarity is a clinical stage radiopharmaceutical company that is uniquely placed to control its full supply chain within the United States. With IAC further planning on additional facilities to support the development of Cu-67 production and with Clarity having recently signed a Letter of Intent with NorthStar Medical to supply and industrialise the production of this therapeutic isotope, we are well underway towards building stable and reliable commercial-scale supply of Cu-67 for our late-phase trials and market entry of our products in a number of large cancer indications".

About Copper-67 (Cu-67)
Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope which is attractive for medical purposes due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumours (NETs), neuroblastoma, glioma, lymphoma, ovarian cancer and bladder cancers. In order to develop safe and effective targeted therapies, a chelator, which strongly binds Cu-67 to the targeting agent, is required. Clarity Pharmaceuticals has successfully developed a highly specific and highly stable chelator for copper isotopes and is now progressing a range of radiopharmaceuticals based on its proprietary MeCOSar chelator. The IAC has developed a proprietary process for production of high purity and high specific activity Cu-67 to meet demand for clinical research and treatment.