NorthStar Medical Radioisotopes LLC

When NUCLIDIUM CEO Leila Jaafar was deciding which radionuclide was the best basis for a targeted diagnostic-therapeutic pair, she had three criteria: not only did it have to be safe and effective, but the compounds needed to be easy to administer at a hospital and lead to limited radioactive waste. After two years of research, the biophysicist and nuclear engineer settled on copper — specifically copper-61 for diagnostics and copper-67, a beta-emitter, for therapeutics.The radioisotope is a new entrant in the growing field of targeted radiopharmaceuticals, which has mostly been dominated by drugmakers using fellow beta-emitter lutetium-177, or emerging alpha-emitters actinium-225 and lead-212 (see – Spotlight On: Radiopharmaceutical report card – 2024).Copper has significant safety, efficacy and manufacturing advantages over other radioisotopes, Jaafar told FirstWord, and now NUCLIDIUM has the backing to prove its programmes' mettle in the clinic. The company raised CHF 79 million ($99 million) in a series B round Thursday to launch Phase IIa studies of its two lead radioligand therapeutics (RLTs) next year for metastatic breast and prostate cancers. The funds will also be used to develop one to two novel targets for colorectal cancer as well as head and neck cancer, and to expand the company's production and manufacturing network.The round was led by Kurma Growth Opportunities Fund, Angelini Ventures, Wellington Partners and Neva SGR, with participation from DeepTech & Climate Fonds, Bayern Kapital,  Vives Partners, Eurazeo, NRW.BANK and HighLight Capital.'What you see is what you treat'NUCLIDIUM's radiotheranostic platform uses tumour-targeting molecules that bind to cell surface receptors, and to copper-61 and copper-67 interchangeably, meaning there's virtually no molecular or chemical difference between each pair's diagnostic and therapeutic besides the radioisotope itself. The company's prostate cancer programme, NuriPro, targets PSMA, while its somatostatin receptor 2 (SSTR2)-targeting pair, TraceNet, is intended to treat gastroenteropancreatic and bronchopulmonary neuroendocrine tumours in addition to breast cancer. One of the key benefits of NUCLIDIUM's radiotheranostic pairs, Jaafar said, is that the tumours identified by the diagnostic on a PET scan are exactly what the therapeutic will target. That's not true for therapeutics using lutetium-177, which has no matching positron emitter and often relies on a gallium- or fluorine-based diagnostic, and thus can't achieve one-to-one targeting. For NUCLIDIUM's copper pairs, however, "the biodistribution of the therapeutic is going to be exactly the same as the diagnostic, and you have then completely de-risked your therapeutic clinical trials by doing the diagnostic first," Jaafar explained. "What you see is going to be what you treat. And what you don't want is for your radiopharmaceutical to go places where it shouldn't be going."Results from a Phase I/II study of its TraceNet diagnostic showed that it consistently lit up patients' tumours on PET scans while healthy tissues and dose-limiting organs like the kidney weren't, suggesting that the therapeutic will have precise tumour-targeting capabilities, also called a high tumour-to-background ratio. Manufacturing, simplifiedThe potential feather in NUCLIDIUM's radiopharmaceutical cap, however, is the ease of its isotope production and theranostic manufacturing workflows. Jaafar explained that besides lutetium-177, copper-67 seems to be the only radionuclide that is already being produced industrially by companies such as NorthStar Medical Radioisotopes. The three-day process is relatively straightforward: when the starting material, zinc-68 — a stable agent that's widely available — is zapped with gamma photons, a photonuclear reaction is triggered, transforming it into copper-67. After that, zinc-68 is separated from copper-67 with a simple chemical process. From there, Jaafar explained, the copper isotope is combined with the targeting molecule and a buffer solution to trigger a quantitative reaction that, within five minutes, results in the RLT, with a yield of 99.9%.The production of other targeted radiopharmaceuticals that use different radionuclides often requires high heat to trigger the reaction, as well as a post-purification step; the latter is not necessary to produce NUCLIDIUM's RLTs, which can also be done at room temperatures. The simple manufacturing process, Jaafar explained, helps NUCLIDIUM to avoid potential pitfalls that could delay getting a decaying product into the hands of doctors. "Any kind of complexities when it comes to manufacturing… will hinder the rest of the supply chain," she said.

NorthStar Medical Radioisotopes has entered into a collaboration deal with YAP Therapeutics, to develop and produce radiopharmaceuticals aimed at treating cancer and other chronic diseases. NorthStar is involved in the development, production, and commercialization of radiopharmaceuticals for therapeutic applications and medical imaging. YAP Therapeutics, a Fjord Ventures company, utilizes its advanced biologic and regenerative medicine technology platforms to develop treatments for chronic diseases. Within this collaboration, NorthStar will support the development of YAP Therapeutics' biologic products by supplying the radioisotope non-carrier added actinium-225 (n.c.a. Ac-225) and providing access to its radiopharmaceutical contract development and manufacturing (CDMO) services. NorthStar will also prepare clinical trial-ready doses of YAP Therapeutics' investigational medicines. Additionally, upon regulatory approval, NorthStar may manufacture and supply radionuclides for YAP Therapeutics' commercial use. “NorthStar leads in medical radioisotope development and production. This agreement furthers our goal to deliver radiopharmaceuticals to patients. We are excited to partner with YAP Therapeutics, merging our technology with their biologics to target specific therapies. Our ability to provide key radioisotopes like Ac-225 and CDMO capabilities offers substantial support to YAP Therapeutics,” said Frank Scholz, President and Chief Executive Officer of NorthStar. "We are thrilled about partnering with NorthStar to improve cancer treatment. Their radiopharmaceutical expertise complements our biologics development. This partnership offers the potential to expand our rich pipeline with leading radioisotope technology," said Olav Bergheim, Founder and Chairman of YAP Therapeutics.

BELOIT, Wis. & LAGUNA HILLS, Calif.--( BUSINESS WIRE )--NorthStar Medical Radioisotopes, LLC and YAP Therapeutics, Inc. have entered into a collaboration agreement to develop and produce radiopharmaceuticals aimed at treating cancer and other chronic diseases. NorthStar is involved in the development, production, and commercialization of radiopharmaceuticals for therapeutic applications and medical imaging. YAP Therapeutics, a Fjord Ventures company, utilizes its advanced biologic and regenerative medicine technology platforms to develop treatments for chronic diseases. Within this collaboration, NorthStar will support the development of YAP Therapeutics' biologic products by supplying the radioisotope non-carrier added actinium-225 (n.c.a. Ac-225) and providing access to its radiopharmaceutical contract development and manufacturing organization (CDMO) services. NorthStar will also prepare clinical trial-ready doses of YAP Therapeutics' investigational medicines. Additionally, upon regulatory approval, NorthStar may manufacture and supply radionuclides for YAP Therapeutics' commercial use. “NorthStar leads in medical radioisotope development and production. This agreement furthers our goal to deliver radiopharmaceuticals to patients,” said Frank Scholz, President and Chief Executive Officer of NorthStar . “We are excited to partner with YAP Therapeutics, merging our technology with their biologics to target specific therapies. Our ability to provide key radioisotopes like Ac-225 and CDMO capabilities offers substantial support to YAP Therapeutics.” “We are thrilled about partnering with NorthStar to improve cancer treatment. Their radiopharmaceutical expertise complements our biologics development,” said Olav Bergheim, Founder and Chairman of YAP Therapeutics . “This partnership offers the potential to expand our rich pipeline with leading radioisotope technology.” About NorthStar Medical Radioisotopes, LLC (NorthStar) NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier added actinium-225 (n.c.a. Ac-225). The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: http://www.northstarnm.com About YAP Therapeutics, Inc. YAP Therapeutics specializes in the development of advanced biologics and genetic medicines to effectively treat chronic diseases. The company's portfolio includes drug-antibody conjugates (ADCs) and radio-labeled biopharmaceuticals aimed at treating life-threatening cancers; advanced biologics designed to effectively treat fibrotic diseases; and targeted AAV-based gene therapy for regenerative medicines. YAP Therapeutics lead gene therapy candidate in development (YAP-101) is aimed at cardiac regeneration through modulation of the Hippo/YAP signaling pathway and related mechanisms. For further information, visit www.yaptx.com .