On May 15, 2023 NUCLIDIUM and PharmaLogic Holdings reported 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 (Press release, NUCLIDIUM, MAY 15, 2023, View Source [SID1234631736]). 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
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.