Clarity partners with Cardinal Health on theranostic TCT clinical trials for cancer care

by John R. Fischer, Senior Reporter | December 10, 2021
Molecular Imaging
Clarity has partnered with Cardinal Health to help with its theranostic clinical trials using Cu-64 and Cu-67
Radiopharmaceutical provider Clarity will conduct clinical trials around its Targeted Copper Theranostics (TCT) platform with help from Cardinal Health’s Center for Theranostics Advancements.

TCT are investigational radiopharmaceuticals that pair copper-64 with copper-67 to diagnose and treat cancer, including pediatric neuroblastoma and prostate and breast cancers. Both have optimal half-lives and can also potentially be used to address glioma, lymphoma, ovarian and bladder cancers.

Clarity is currently assessing both in a trial for the TCT treatment of metastatic prostate cancer. The center will help in this and other endeavors that Clarity carries out around this combination by providing cGMP product manufacturing of ready-to-use TCT. Under cGMP criteria, both will undergo newer and more in-depth testing to ensure they are up to date with current practice standards.
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“Cardinal Health has an intricate understanding of the supply chain requirements for copper-based products and the capability to mass-produce these products,” said Clarity’s executive chairman, Dr. Alan Taylor, in a statement.

Cu-67 is domestically produced in the U.S. without a nuclear reactor, has no long-lived contaminants or byproducts and its starting material, zinc, is readily available. It also has a centralized distribution that is well-proven in yttrium-90, an isotope with a comparable half-life, and samarium-153, which has a much shorter half-life. The half-life of copper-64, meanwhile, is closely similar to that of iodine-123, which is routinely used as the proven standard in nuclear medicine for the diagnosis of thyroid cancer and other physiological abnormalities in the thyroid.

Once approved by the FDA, Clarity’s TCT platform will be offered as ready-to-use by patients in any location in the U.S. from a single manufacturing site.

Another company it is partnering with on this endeavor is Evergreen Theragnostics. Along with Cardinal Health, Evergreen will provide a reliable, seamless supply of ready-to-use cGMP TCTs for Clarity's expanding clinical programs across the U.S. And because of the proximity of its New Jersey-based facility to various forms of transportation and the optimal half-lives of Cu-64 and Cu-67, Evergreen will be able to distribute TCTs to hospitals across North America as well as reach European markets.

The company also partnered with NorthStar back in May. As part of their agreement, NorthStar will supply Cu-67 exclusively to Clarity as an active pharmaceutical ingredient to support Clarity’s TCT programs. Like with molybdenum-99, NorthStar’s production processes for Cu-67 are environmentally friendly and non-uranium-based.

“We are very pleased to enter this agreement and hope it will be another avenue for us to help improve access to next-generation radiopharmaceuticals for diagnosis and treatment of a range of cancers,” said Cardinal Health nuclear and precision health solutions president Mike Pintek.

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