Clarity Pharmaceuticals Expands Copper-64 Supply Chain
Highlights of the Agreement
- Clarity has established a commercial-scale Supply Agreement with Nusano, Inc. for the provision of copper-64 (Cu-64) isotope.
- Nusano operates a 190,000 square foot cutting-edge facility capable of manufacturing over 1,000 Ci (37,000 GBq) of copper-64 daily, facilitating the production of more than 18,000 patient doses per day at 200 MBq per dose, featuring a shelf-life of 48 hours, significantly surpassing the needs of various large medical applications.
- This copper-64 supply will enhance Clarity's US supplier network, ensuring the steady production of this essential diagnostic isotope as the company advances through late-stage clinical trials and approaches commercialization.
- In addition, Nusano intends to initiate production of other medical isotopes, including copper-67 and actinium-225, in 2025-2026, both vital for Clarity's product line.
Company Overview
Clarity Pharmaceuticals (ASX: CU6), a clinical-stage radiopharmaceutical organization dedicated to developing and commercializing next-generation therapies that offer improved outcomes for cancer patients, has successfully signed a significant copper-64 Supply Agreement with Nusano.
Nusano's advanced facility is slated to kick off production in 2025, aiming to deliver copper-64 isotopes starting early in 2026. The proprietary, accelerator-based technology at Nusano is crafted for efficient and cost-effective mass production of copper-64. With a daily output capacity exceeding 1,000 Ci, the facility is set to play a pivotal role in meeting the rising demand for this isotope in numerous oncology applications, aligning well with Clarity's commercialization strategy.
Dr. Alan Taylor, Clarity's Executive Chairman, stated, "This Supply Agreement with Nusano will enhance our US supply network of copper-64, ensuring we have the capacity to provide a seamless supply of the isotope. Our ongoing data generation in late-stage clinical trials positions us well for a strategic, large-scale supply rollout of our Targeted Copper Theranostics (TCTs) in the US healthcare market, the largest in the world."
Dr. Taylor emphasized the significance of a stable isotope production integrated within the US geopolitical landscape. He noted, "Developing a source that allows us to manufacture isotopes domestically ensures that we can provide timely and consistent diagnostics across the nation, unaffected by external political or economic concerns. This strategy aims to deliver streamlined accessibility to imaging sites nationwide, enhancing patient care in oncology."
Strategic Importance of Isotope Production
In major oncology sectors, like prostate-specific membrane antigen (PSMA) positron emission tomography diagnostics, consistent and reliable isotope availability is critical for a successful product rollout. Clarity is focused on overcoming the limitations of existing products, which often fail due to their short half-life and limited availability during work hours. The longer half-life of copper-64, at 12.7 hours, compared to other isotopes, supports a wider operational window for imaging facilities.
Dr. Taylor elaborated, "Drawing from our experiences with contemporary radio-diagnostics, effective supply management is decisive for both product adoption and market expansion. We are dedicated to developing a strong foundation for our TCTs, facilitating better diagnostic capabilities globally. Our unique model aims to ensure copper-64 diagnostics are available on demand, allowing clinicians greater flexibility in administering diagnoses, potentially improving cancer identification and treatment paths for patients."
Nusano's Role and Future Aspirations
Chris Lowe, Nusano's Chief Executive Officer, expressed his enthusiasm for the partnership, stating, "Our advanced radioisotope production platform aims to deliver more than 25 products for life sciences by 2025, including crucial isotopes like copper-64, copper-67, and actinium-225. We are thrilled to support Clarity with reliable radioisotope supplies to fuel their clinical pursuit and commercial objectives from our state-of-the-art facility."
As per the terms, the Supply Agreement is active for three years, with options for extension every two years thereafter, subject to standard industry practices for cancellation.
About Clarity Pharmaceuticals
Clarity Pharmaceuticals is at the forefront of developing innovative radiopharmaceuticals targeted at treating serious diseases. Utilizing the advanced SAR Technology Platform, the company is focused on creating Targeted Copper Theranostics effective in cancer treatment.
About Nusano
Nusano is a privately owned physics enterprise dedicated to ensuring stability and groundbreaking advances in the essential medical radioisotope market, equipped to fulfill various sectors reliant on consistent access to high-quality radioisotopes. With its proprietary ion source, Nusano stands ready to supply a diverse array of radioisotopes, significantly impacting cancer treatment and innovation in numerous industries.
Frequently Asked Questions
What is the main purpose of the agreement between Clarity and Nusano?
The agreement primarily aims to secure a reliable supply of copper-64 isotopes for Clarity’s oncology products, enhancing diagnostic capabilities.
When is Nusano expected to start producing copper-64?
Nusano plans to begin production of copper-64 in early 2026.
Why is copper-64 significant for cancer treatment?
Copper-64 has a longer shelf-life than many other isotopes, allowing for more flexibility in patient imaging and potentially improved detection of cancer lesions.
What other isotopes is Nusano planning to produce?
Nusano is also developing production capabilities for copper-67 and actinium-225 starting in 2025-2026.
How does this partnership affect Clarity's clinical trials?
This partnership ensures Clarity has a robust and consistent supply of copper-64, which is crucial as they progress through late-stage clinical trials leading to commercialization.
