NorthStar Medical Radioisotopes LLC

iStock, Mariia Bicher The necessity of delivering medicine days after it’s produced drives decisions about where to build facilities and how to ship radioactive materials to healthcare providers. Radiopharmaceutical supply chains are defined by a ticking clock. From the minute an isotope is made, it starts to decay, gradually emitting fewer cancer-killing radioactive particles. The limited half-life of radiopharmaceuticals means the drugs “are like melting ice cubes,” Justin Butler, a partner at Eclipse Ventures, told BioSpace . That countdown compels investments in manufacturing facilities and supply networks designed to quickly and reliably deliver the medicines to patients. NorthStar Medical Radioisotopes approaches that challenge by working back from when a patient needs to receive treatment to ensure the drug is at the site of care in time, CEO Frank Scholz told BioSpace . The goal is to avoid a situation like that described by Nucleus RadioPharma CEO Steve Hahn, who described a patient who flew from Alaska to Mayo Clinic only to learn their radiopharmaceutical had yet to arrive. Mitigating Risks How companies structure their supply chains to mitigate such risks depends on the radioisotope. Scholz said NorthStar ships actinium-225 from its facility in Wisconsin to patients in Asia, Australia and Europe, reflecting the isotope’s relatively long 9.92-day half-life—meaning it takes that long for the radiation emitted by the isotope to fall by half. However, a decentralized approach may be required for isotopes such as yttrium-90, a liver cancer treatment with a 64-hour half-life. Every hour matters even when shipping isotopes with half-lives measured in hours or days. NorthStar has based its manufacturing site close to five airports to ensure fast access to planes, which are the dominant form of transport of the medicines. Air transport is essential to all global shipping and to reaching many patients in the U.S. However, there are risks to moving materials by plane. Radioactive materials can fail to take off at the scheduled time for a wide range of reasons, from bad weather to the unavailability of suitable aircraft to a pilot’s refusal to fly with the cargo, Scholz said. Flying materials on private planes, rather than commercial networks, mitigates some risks but is more expensive. Hahn said Nucleus considers overland shipping to sites within six to eight hours of its facilities because it is more reliable than sending materials by air. Scholz said NorthStar uses trucks when radiopharmacies or treatment centers are within roughly six hours of its facilities, explaining that overland shipping can be a cheaper option with more predictable arrival times. Manufacturers use tracking technology on these shipments, potentially providing healthcare facilities with early notice of delays. Hahn compared the technology to systems that allow consumers to track the products they buy online, adding that the tools are relatively novel in the pharma industry and that it is “not so common” for providers to be able to monitor shipments. Companies can build extra time into the shipping schedule to increase the likelihood that the medicine will arrive by the patient’s appointment even if there are delays. There are downsides to that approach, though. If a buffer is built into the schedule and shipping goes as planned, the medicine will arrive early and spend time decaying at the healthcare facility before being administered. Using more reliable overland shipping can reduce the need for extra time in the schedule. Designing Manufacturing Networks Nucleus’ expansion plans will increase the number of sites that can be reached overland in eight hours. The company is based in Rochester, Minnesota, reflecting its ties to Mayo Clinic. Hahn said Nucleus is setting up a facility outside Philadelphia to serve the East Coast and plans to add a West Coast site in three to five years. The Philadelphia facility will also be capable of shipping to Europe, Hahn said. The company will be “strategic in where we place any facilities or partnerships we form so we reach as many people as possible,” Hahn said. Such considerations are informing the company’s approach to serving the Asian market. “I think it is very likely that an Asian presence for a company like Nucleus is going to be necessary,” Hahn said. “That could be in partnership with other companies, so that you can ship all over Asia. The transportation networks are very well developed there and that, probably, from a time point of view, is the best way to do it.”

ATHENS, Greece & BELOIT, Wisc.--(BUSINESS WIRE)--BIOEMTECH, a developer of high-resolution PET and SPECT imaging systems for preclinical and translational research, today announced a strategic supply agreement with NorthStar Medical Radioisotopes (NorthStar) to secure a reliable supply and provide Actinium-225 (Ac-225) for use in preclinical studies conducted by BIOEMTECH customers. This agreement will provide BIOEMTECH’S customers with consistent access to Ac-225, a critical alpha-emitting isotope used in the development and evaluation of targeted radiotherapeutics. The supply arrangement is aimed at accelerating preclinical radiopharmaceutical development by ensuring timely, compliant access to high-quality isotope material compatible with a wide range of investigational studies. “We are pleased to partner with NorthStar Isotopes to strengthen access to Ac-225 for the preclinical research community,” said Dr. Maritina Rouchota, Chief Quality Officer of BIOEMTECH. “Reliable isotope supply is a major bottleneck in early radiopharmaceutical development. This agreement enables our customers to run more predictable, higher-impact studies using our imaging platforms.” “NorthStar is committed to expanding Ac-225 supply for the growing radiopharmaceutical market,” said Frank Scholz, President and CEO of NorthStar Medical Radioisotopes. “Working with BIOEMTECH to support preclinical researchers aligns with our mission to advance global access to radiopharmaceuticals with dependable isotope supply with the required quality and regulatory standards.” Key elements of the agreement encompass: Supply scope: Regular, scheduled deliveries of Ac-225 tailored for preclinical dosing and research timelines. Quality and compliance: Material supplied under validated procedures meeting applicable regulatory and transport standards for research isotopes. Research enablement: Coordinated logistics and technical support to integrate isotope delivery with BIOEMTECH’s preclinical imaging services and customer timelines. Timeline: Initial deliveries to begin in Q1 2026 with scalable volumes based on research demand. BIOEMTECH customers and partners will be able to request Ac-225 supply through BIOEMTECH’s ordering channels; NorthStar will provide isotope-specific documentation and handling guidance to support laboratory safety and study reproducibility. About BIOEMTECH BIOEMTECH is a preclinical radiopharmaceutical focused CRO which also designs and manufactures high-resolution PET and SPECT imaging systems for preclinical and translational research. BIOEMTECH’S imaging systems and services support pharmaceutical, biotech, and academic researchers in advancing molecular imaging and therapeutic development. About NorthStar Medical Radioisotopes NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company advancing patient care through innovative, commercial-scale production of therapeutic and diagnostic radioisotopes. The company’s industry‑leading position in radiopharmaceutical therapy is driven by its unique production capabilities, proven leadership team, and state‑of‑the‑art, environmentally preferable technologies. NorthStar routinely produces copper‑67 (Cu‑67) and is the first commercial‑scale producer of non‑carrier‑added actinium‑225 (n.c.a. Ac‑225) using electron accelerator technology. Its Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) provides specialized expertise and tailored services to help biopharmaceutical partners accelerate development and commercialization. Learn more at . Contacts Media contacts BIOEMTECH Nick Afentoulides Vice President, Business Development 203-515-1443 nafentoulides@bioemtech.com NorthStar Medical Radioisotopes Gauri Gupta Chief Strategy & Transformation Officer 312-288-5431 ggupta@northstarnm.com

Aktis Oncology 正研发一款自主研发的微型蛋白平台，该平台可靶向肿瘤蛋白并搭载放射性载荷，同时支持肿瘤显像与 α 射线放射治疗。 Aktis Oncology 公司宣布，其于 2026 年 1 月 12 日完成超额配售的首次公开发行（IPO），以每股 18.00 美元的价格发行 1765 万股普通股。承销商亦全额行使超额配售权，以相同价格额外认购 265 万股股份，在扣除承销折扣及发行费用前，此次 IPO 总募资额约达 3.654 亿美元。 该公司普通股已于 1 月 9 日在纳斯达克全球精选市场挂牌交易，股票代码为 AKTS。 此次 IPO 为这家总部位于波士顿、处于临床阶段的生物科技公司注入了新的资金，助力其推进实体瘤靶向放射性药物的研发管线。 Aktis 依托自主研发的微型蛋白工程化小分子蛋白平台开展疗法研发，这类分子经设计可特异性结合肿瘤细胞表面的特定蛋白，并将放射性载荷递送至肿瘤靶点部位。 公司在招股书中表示，该微型蛋白的分子尺寸兼具双重优势：足够大以实现类抗体的靶向特异性，又足够小以高效穿透实体瘤组织，且能更快从正常组织中清除。同款靶向分子可连接显像或治疗性同位素，使该平台同时支持肿瘤可视化显像与靶向放射性递送。 Aktis 研发进度最快的管线产品为Ac-AKY-1189，其靶向Nectin-4蛋白 —— 该蛋白在尿路上皮癌及多种其他实体瘤中表达，而在成年人体大部分正常组织中表达量极低。这款候选药物由靶向 Nectin-4 的微型蛋白与 α 粒子发射型放射性核素Ac-225偶联而成。 目前 Aktis 正在美国开展多中心 Ib 期临床试验，评估该化合物用于治疗局部晚期或转移性尿路上皮癌及其他表达 Nectin-4 的实体瘤患者的疗效与安全性。该试验旨在评估药物的安全性、放射性分布及早期临床信号，预计 2027 年公布初步的剂量递增试验结果。 公司第二款临床管线产品为 Ac-AKY-2519，其靶向B7-H3蛋白 —— 这是另一类肿瘤相关表面蛋白，在前列腺癌、肺癌、乳腺癌等多种实体瘤中均有表达。Aktis 已利用该候选药物的诊断版本完成早期显像及剂量学研究，并计划于 2026 年上半年提交新药临床试验申请（IND）。若获得 FDA 批准，公司拟在 2026 年下半年启动该产品的 Ib 期临床试验。 除自主研发管线外，Aktis 还与 Eli Lilly 达成发现合作协议，针对其内部管线外的肿瘤靶点开发新型靶向放射性药物候选物，同时 Aktis 将保留其自主研发产品组合的全球开发与商业化权利。此次 IPO 的募资将用于支持上述各项研发工作。 Aktis 计划划拨约 1.4 亿至 1.5 亿美元，推进其靶向 Nectin-4 管线的在研 Ib 期临床试验；划拨约 7000 万至 8000 万美元，推动靶向 B7-H3 管线进入 Ib 期临床试验阶段。 与此同时，公司正构建同位素供应合作体系，并打造内部的现行药品生产质量管理规范（cGMP）生产设施，为临床药物生产及未来的产能扩增提供支持。该生产设施预计于 2026 年下半年投入运营。 除 Aktis 正在研发的基于微型蛋白的靶向技术外，业内其他机构也在推进多种剂型的放射性药物研发，包括基于抗体的放射性配体疗法、以及可将 α 粒子发射型同位素递送至经充分验证的肿瘤靶点的放射性抗体偶联药物。 今年 1 月，Swiss Rockets 与 Alloy Therapeutics 宣布达成多靶点研发合作，整合双方的发现平台与放射化学、同位素研发技术，开发新型基于抗体的放射性配体疗法。 同期，Convergent Therapeutics 与 NorthStar Medical Radioisotopes 深化合作，为其处于晚期研发阶段的、靶向 PSMA（前列腺肿瘤中高表达的细胞表面蛋白）的 α 粒子放射性抗体锁定专属的Ac-225 生产产能，该药物拟用于治疗转移性去势抵抗性前列腺癌。 Actinium Pharmaceuticals 亦公布了其基于Ac-225 的抗体放射性偶联药物 ATNM-400 在实体瘤模型中的最新临床前研究数据。 往期回顾 大阪大学与 Sumitomo Heavy Industries 合作研发砹类放射性药物 英国首批患者接受 Blue Earth Therapeutics 研究性放射性药物疗法 ——Lu-177 rhPSMA-10.1 注射液治疗转移性去势抵抗性前列腺癌 新型诊疗一体化放射性药物组合有望攻克上消化道肿瘤 汇佳生物专注于转化医学领域的前沿研究及临床转化应用技术，业务涵盖生物标志物和药物靶标技术，新型诊断试剂及治疗药物的研发，相关仪器设备的开发及临床转化技术的应用，实现了产、医、研的融合发展。 媒体合作/科研宣传/产品咨询 长按二维码，联系我们