August 29, 2023 — NorthStar Medical Radioisotopes, LLC (“NorthStar"), a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic and medical imaging applications, is pleased to announce that the first patient has been dosed in a clinical trial using NorthStar’s electron accelerator-produced Cu-67. Administration of the therapeutic dose took place as part of an ongoing Phase I/IIa theranostic clinical trialconducted by Clarity Pharmaceuticals to investigate the safety and efficacy of Cu-67 SARTATE in pediatric patients with high-risk neuroblastoma. The event marks a key milestone in the exclusive Cu-67 supply agreement between both companies.
NorthStar is producing high-activity, high specific-activity and high-purity Cu-67 for use in Clarity’s clinical programs as part of an agreement to exclusively supply Cu-67 to Clarity. Clarity will use NorthStar-produced Cu-67 for its three actively recruiting theranostic clinical trials evaluating the safety and efficacy of 67Cu SARTATE, 67Cu SAR-bisPSMA and 67Cu SAR-Bombesin, as well as future commercialization of its Targeted Copper Theranostic (TCT) products.
NorthStar is the first commercial-scale supplier of this important Cu-67 therapeutic radioisotope, and Clarity leads the world in copper based theranostics. NorthStar’s Cu-67 production process uses highly efficient, environmentally preferable electron accelerator technology and the NorthStar radioisotope has proven suitable for radiolabeling of Clarity’s products using their proprietary SAR Technology platform. The platform is enabled by unique SAR chelators, that are specialized cage-like structures that securely hold copper radioisotopes. Unlike traditional chelators, SAR chelators prevent leakage of copper isotopes into the body. Once securely attached to a targeting molecule, the chelated Cu-67 delivers therapeutic doses of radiation to destroy cancer cells with limited damage to healthy tissue.
Clarity’s Executive Chairman, Dr. Alan Taylor, stated, “Large-scale manufacture of therapeutic Cu-67 from highly efficient, environmentally preferable electron accelerators is critical to overcome the widespread supply issues in the radiopharmaceutical industry, due to a heavy reliance on a small number of antiquated nuclear reactors. Clarity continues to recruit higher numbers of participants at increasingly higher activities of Cu-67 across all three of our therapeutic clinical trials.”
“Reliable commercial-scale production of high specific activity Cu-67 complements our development efforts, with end-to-end production, from radioisotope through to finished product, and advantageously positions Clarity to realize the many supply and manufacturing advantages associated with TCTs. It supports a sustainable future for radiopharmaceuticals unencumbered by manufacturing, logistical and environmental issues inherent to many radiopharmaceuticals. We believe that TCTs present an efficacious, scalable, sustainable and cost-effective way to expand radiopharmaceuticals into the large, global oncology market and we look forward to continuing our collaboration with NorthStar as we realize our shared goal of improving treatment outcomes for children and adults with cancer,” continued Dr. Taylor.
NorthStar Medical Radioisotopes' President and Chief Executive Officer, Frank Scholz, Ph.D., commented, “The fact that the initial human use of NorthStar’s electron accelerator-produced Cu-67 is in a clinical trial designed to treat children with high-risk neuroblastoma underscores the importance of our work in advancing innovation to promote patient health, and we hope that we can help children and their caregivers who are affected by this serious disease. NorthStar continues to drive commercial-scale innovation solutions for our industry, to meet the needs of patients and advance clinical research.
Our efforts use the proven expertise and innovative approach demonstrated in the successful development and commercialization of our other domestically-produced, non-uranium based radioisotope. We are pleased and honored to be part of this important clinical trial, and look forward to continuing to support Clarity’s plans for further clinical development and commercialization of Cu-67-based radiopharmaceutical therapies, with the aim to improve the lives of patients with serious disease.”
About Therapeutic Radioisotope Copper-67 (Cu-67)
Copper-67 (Cu-67) is an optimal-range, beta-emitting radioisotope that can be produced at commercial scale with high specific activity and without long-lived radioactive impurities. Cu-67 delivers cancer-killing radiation to target cells and is being investigated for therapeutic purposes across a wide range of adult and childhood cancers, including prostate and breast cancers. A chelator, which strongly binds Cu-67 to the targeting agent and prevents its leakage in vivo, is required to develop safe and effective targeted therapies. Clarity has successfully developed a highly specific and highly stable chelator for copper isotopes and is progressing clinical trials of a range of radiopharmaceutical products based on its proprietary SAR Technology Platform. NorthStar is rapidly advancing its proprietary process for commercial-scale production of Cu-67 to meet demand for clinical research and eventual commercial supply of TCTs.
About the CL04 Clinical Trial
The CL04 trial (NCT04023331)1 is a theranostic trial evaluating 64Cu/67Cu SARTATE for diagnosis and treatment of high-risk neuroblastoma, an aggressive childhood cancer. It is a multi-centre, dose-escalation, open label, non-randomised, Phase I/IIa clinical trial with up to 34 participants conducted across eight clinical sites in the United States.
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), including neuroblastoma and neuroendocrine tumors (NETs). Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu SARTATE) or copper-67 (67Cu) for therapy (67Cu SARTATE).
Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumor grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of pediatric cancer mortality2. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%3.
For more information: www.northstarnm.com