Highlights

• First participant of cohort 4 of the theranostic CL04 trial investigating ⁶⁴Cu/⁶⁷Cu SARTATE in neuroblastoma has been treated at the highest dose cohort of 375MBq/kg body weight using NorthStar’s electron accelerator-produced Cu-67, marking a key milestone in NorthStar’s agreement to exclusively supply Cu-67 to Clarity
• NorthStar now routinely produces high-activity, high specific-activity and high-purity Cu-67 for Clarity’s ongoing clinical programs
• Clarity’s Phase I/IIa theranostic clinical trial in the United States for high-risk neuroblastoma utilizes the “perfect pairing” of SARTATE with copper-64 (Cu-64) for diagnostic imaging and Cu-67 for radiopharmaceutical therapy (RPT)
• Clarity is the global leader in copper-based theranostics, using proprietary SAR Technology to enable the use of copper isotopes in next-generation radiopharmaceuticals
• NorthStar’s commercial-scale Cu-67 production uses highly efficient, environmentally preferable electron accelerator technology to meet Clarity’s growing demand

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 trial conducted 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.

About SARTATE

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).

About Neuroblastoma

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour 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 paediatric 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.

About NorthStar Medical Radioisotopes, LLC

NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company focused on advancing patient care by providing diagnostic and therapeutic radioisotopes, novel radiopharmaceuticals and customized radiopharmaceutical development services. Its proven management team and state-of-the-art, environmentally preferable and non-uranium based technologies have made it an emerging leader at the forefront of U.S. medical radioisotope and radiopharmaceutical production. NorthStar’s molybdenum-99 (Mo-99) program is the sole source of domestic Mo-99, used to generate the standard-of-care diagnostic imaging radioisotope for assessing heart disease and cancer. It is expanding its industry-leading position in the growing area of therapeutic radioisotopes, used in targeted radiopharmaceutical therapy to treat cancer and other serious diseases, and is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) actinium-225 (Ac-225) and copper-67 (Cu-67). NorthStar’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO/CMO) services unit will provide customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercialization programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com.

About Clarity Pharmaceuticals

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults.

www.claritypharmaceuticals.com

References

1. ClinicalTrials.gov Identifier: NCT04023331, https://clinicaltrials.gov/ct2/show/NCT04023331
2. Nadja C. Colon and Dai H. Chung 2011, “Neuroblastoma”, Advances in Pediatrics, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668791
3. Valeria Smith and Jennifer Foster 2018, “High Risk Neuroblastoma Treatment Review”, Children, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6162495/

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