03 December 2021 | Friday | News
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Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, and Cardinal Health (NYSE: CAH), are pleased to announce that the companies have entered into an agreement covering Clarity's Targeted Copper Theranostics (TCT) platform.
Cardinal Health will provide cGMP product manufacturing of ready-to-use TCT for Clarity's U.S.-based clinical trials from its Center for Theranostics Advancement in Indianapolis, Indiana. TCT are investigational radiopharmaceuticals that pair copper-64 (64Cu) and copper-67 (67Cu) for diagnosis and therapy.
With more than 40 years of experience in the radiopharmaceutical industry, Cardinal Health provides radiopharmaceutical development support, manufacturing, preparation, commercialization, and business and practice management solutions across the care delivery continuum from origin to patient administration. Its Center for Theranostics Advancement is helping shape the future of precision medicine by providing radiopharmaceutical innovators the solutions they need at every stage of the product lifecycle.
Clarity's Executive Chairman, Dr Alan Taylor, said, "We are pleased to have further strengthened and expanded our U.S. manufacturing capabilities, ensuring seamless product supply for our clinical trials, including those in cancer indications with large patient populations. Cardinal Health has an intricate understanding of the supply chain requirements for copper-based products and the capability to mass-produce these products.
"This is a testament to Clarity's pairing of copper isotopes fitting into the 'goldilocks zone' of half-lives when considering biological half-life of the targeting moieties, centralized manufacture, and broad distribution. The half-life of copper-64 is nearly identical to that of iodine-123, for which Cardinal Health has an established and robust distribution system across the U.S. For the therapeutic isotope copper-67, centralized distribution is well proven in an isotope of comparable half-life, yttrium-90, or the much shorter half-life of samarium-153."
Cardinal Health™ Nuclear & Precision Health Solutions President Mike Pintek, said, "We are excited to be working together with Clarity on the manufacturing and pharmacy dispensing of the TCT platform of investigational products. The 64Cu and 67Cu isotope pairing holds great promise for the field of radiopharmaceuticals as they are ideally suited for central manufacturing of cGMP ready-to-use products; they will fit easily within our broad distribution network. 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."
Dr Alan Taylor said, "Clarity's TCT platform is clearly differentiated in the radiopharmaceutical field as all products, once approved by the FDA, can be provided as ready-to-use to patients in any location in the U.S. from a single manufacturing site. The manufacturing agreement with Cardinal Health, in addition to the recent manufacturing agreement signed with Evergreen Theragnostics and other partners, will enable Clarity to create redundancies in the supply of our products – ensuring that we can provide a reliable, seamless supply of TCT that is unique for a company in the radiopharmaceutical field. This agreement further enables Clarity to continue to pursue our ultimate goal of improving treatment of children and adults with cancer."
This announcement has been authorized for release by the Executive Chairman of Clarity Pharmaceuticals.