Collaboration agreement strengthens 61Cu-supply chain capabilities for clinical development in North America
BASEL, Switzerland and BOCA RATON, Fla., May 15, 2023 /PRNewswire/ — NUCLIDIUM and PharmaLogic Holdings today announced that they have entered into a strategic collaboration agreement for the production and clinical supply of 61Cu in the United States to accelerate the development of NUCLIDIUM’s theranostic pipeline. By combining copper radiometals with highly specific cancer-targeting molecules, NUCLIDIUM’s theranostic approach aims to offer innovative diagnostic and therapeutic treatments for patients suffering from a range of solid tumours. The partnership with PharmaLogic will provide NUCLIDIUM with a sustainable supply of 61Cu in the United States both for its planned clinical trials as well as future commercialized products. NUCLIDIUM has developed a proprietary production process for high-quality 61Cu, a novel diagnostic radioisotope that offers unique properties for safe, economical, and highly efficient diagnostics to improve cancer-staging and subsequent treatment decisions.
Under the terms of the agreement, NUCLIDIUM will provide PharmaLogic with the scientific know-how, proprietary technology, and raw material to enable PharmaLogic to safely and accurately produce high-quality 61Cu-radionuclides and radiopharmaceuticals in their manufacturing facilities throughout the US. The first product batch is planned to be manufactured in 2023 at PharmaLogic’s location in Los Angeles, California. NUCLIDIUM will retain all rights to its proprietary platforms and technologies. Financial details of the collaboration were not disclosed.
“PharmaLogic is a well-established and highly experienced CDMO with a robust manufacturing network to supply diagnostic and therapeutic radiopharmaceuticals across North America. Their commitment to work with us emphasises the opportunity represented by our innovative theranostic approach. With this agreement, we are further ensuring the sustainable supply of copper-based isotopes to advance our programs towards the clinic, specifically two of our pipeline candidates which are targeted to reach the clinic this year,” said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM.
“Targeted radiotheranostics offer a novel, personalized solution for cancer patients with the potential to become an integral part of cancer diagnosis and treatment. NUCLIDIUM’s copper-based platform has the ability to bring us closer to this vision, and I look forward to working with this highly skilled team to advance radiopharmaceutical products jointly and serve cancer patients in North America by reliably providing them with clinically relevant medical options,” said Steve Chilinski, CEO of PharmaLogic.
61Cu radionuclides are uniquely positioned to transform the diagnosis of particularly hard-to-diagnose tumours. They can be produced through easily accessible source material and, in contrast to other available diagnostics, have a half-life that enables delayed imaging to find even the smallest metastasis. In addition, 61Cu decays into a stable isotope which keeps the radiation burden for the patient low and reduces waste at the treatment sites. NUCLIDIUM’s easy-to-apply proprietary production process allows for fast and easy integration into an installed cyclotron and existing supply networks for PET-FDG, making it a safe and economical solution for producing radiopharmaceuticals.
About NUCLIDIUM’s Copper-based Platform
Nuclidium’s copper-based platform enables an easy adjustment of each product candidate from a diagnostic to a therapeutic by simply exchanging 61Cu with 67Cu. Through this approach, both product candidates are biodistributed in the body identically, allowing for exact dosimetry for each patient. This seamless “diagnostic to therapeutic” approach offers the potential for more personalised, efficacious, and safe patient care compared to other radiopharmaceuticals that use different radioisotopes and/or targeting molecules for diagnosis and treatment. Importantly, the easy-to-apply proprietary production process and half-live properties of the copper radioisotopes contribute to a superior radiotheranostic product with broad availability.
NUCLIDIUM is setting a new standard in the precision oncology landscape by developing best-in-class copper-based radiopharmaceuticals that enable the highest accuracy and accessibility for targeted cancer treatment and diagnosis. Our flexible CuTrace™ platform combines copper radiometals with a variety of highly specific cancer-targeting molecules to rapidly develop novel diagnostic and therapeutic programs. The resulting product portfolio leverages the unique properties of copper to achieve an improved safety and efficacy profile with advantageous economics for hospitals and patients. NUCLIDIUM’s differentiated “diagnostic to therapeutic” approach de-risks our development pathway. With innovation as our core, we overcome supply limitations in manufacturing and distribution, bringing greater flexibility to medical facilities. We are a diverse and interdisciplinary team focused on changing precision radio-oncology for the better to deliver a true benefit to cancer patients.
About PharmaLogic Holdings Corporation
PharmaLogic is a world-class contract development and manufacturing organization specializing in novel diagnostic imaging and therapeutic radiopharmaceuticals for the treatment of cancers and other malignancies. In addition to an established and reliable network of radiopharmacies, PharmaLogic has decades of expertise in drug development from discovery, through manufacturing and commercialization. The Company seeks to take the lead in the advancement of radiopharmaceutical technology for the benefit of patients worldwide. For more information, visit: www.radiopharmacy.com
SOURCE PharmaLogic Holdings Corp