Validation Engineer 2

NorthStar and QSA Global announce multi-year strategic partnership to strengthen actinium-225 supply chain for Targeted Alpha Therapies. May 27, 2026, 09:00 ET * Strategic partnership combines NorthStar's commercial-scale radioisotope production capabilities with QSA Global's expertise in lifecycle management of Radium-226 (Ra-226), the starting material for Ac-225 production * Agreement aims to strengthen NorthStar's no carrier added (n.c.a) Ac-225 supply chain by establishing a reliable, closed-loop source of high-purity Ra-226 target materials BURLINGTON, Mass. and BELOIT, Wis., May 27, 2026 /CNW/ - QSA Global, Inc., a global leader in specialized radioactive source manufacturing and medical radiochemical services, and NorthStar Medical Radioisotopes, LLC (NorthStar), a leading radiopharmaceutical company, today announced the execution of a multi-year strategic services agreement. This partnership is designed to solidify the supply chain for radium-226 (Ra-226) targets, the starting material for Actinium-225 (Ac-225) production, and further supports NorthStar's commercial-scale production of no carrier added (n.c.a.) Ac-225 used in next-generation Targeted Alpha Therapies (TAT). The partnership combines QSA Global's decades of specialized experience in high-activity source handling, industrial regulatory compliance, and logistics with NorthStar's innovative approach to commercial-scale radiopharmaceutical production. It features a multi-year purification campaign where QSA Global will process legacy Ra-226 on behalf of NorthStar, transforming the material into high-purity precursors that will directly feed continuous target capsule manufacturing. Following irradiation and processing by NorthStar to produce n.c.a Ac-225, the recovered radium will be returned to QSA Global for recycling into new targets - establishing a highly efficient, closed-loop supply chain. "This multi-year agreement with QSA Global strengthens our supply chain with a reliable, high-quality supply of Ra-226 targets critical to our n.c.a. Ac-225 production capabilities," said Dr. Frank Scholz, President & CEO of NorthStar. "By ensuring consistent access to these vital starting materials, we can confidently meet growing demand within the industry." "By managing the complex, highly regulated lifecycle of radium-226, QSA Global enables partners like NorthStar to focus their resources entirely on commercial Actinium-225 production," said DR. Joe Lapinskas, Innovation Director at QSA Global, Inc. "NorthStar was a foundational partner as we developed our specialized radium services. We are proud to leverage our decades of high-activity radioactive materials expertise to help secure this critical supply chain and support NorthStar's mission of delivering life-saving TATs to patients." About Ac-225 NorthStar has been successfully producing n.c.a Ac-225 using an indirect manufacturing approach that combines electron-accelerator irradiation of a Ra-226 target, followed by purified Ra-225 sources that constantly in-grow n.c.a Ac-225. Ac-225 is an alpha-emitter, which belongs to a powerful class of radioisotopes that deliver high-energy, highly localized radiation directly to diseased cells. Ac-225 can be attached to a variety of targeting molecules, including antibodies, peptides, and small molecules, enabling precise delivery to cancer cells. This versatility makes isotopes like Ac-225 particularly valuable in supporting the development of next-generation radiopharmaceutical therapies that are highly effective and selective. About QSA Global, Inc. QSA Global, Inc. is a worldwide leader in the design, manufacture, and distribution of high-performance radiation sources and equipment. Building upon a decades-long legacy of excellence in industrial radioisotope products, QSA Global has strategically expanded its capabilities to serve the rapidly growing medical radioisotope and Targeted Alpha Therapy (TAT) markets. With state-of-the-art facilities and unparalleled expertise in radiochemical processing, purification, and regulatory compliance, QSA Global provides foundational supply chain security for the next generation of life-saving medical treatments. About NorthStar Medical Radioisotopes, LL (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 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. 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: www.northstarnm.com Media Contacts: For QSA Global, Inc.: For NorthStar: Investor Relations: Victor Miller Chief Financial Officer 847-650-3860 [email protected] SOURCE QSA Global, Inc.

NorthStar Medical Radioisotopes has received FDA acceptance of its Type II Drug Master File for no-carrier-added Actinium-225, a radioisotope used in cancer treatment. The approval allows pharmaceutical partners to reference NorthStar's manufacturing and quality controls in their drug applications, streamlining regulatory pathways for targeted alpha therapy development. The Beloit, Wisconsin-based company produces Ac-225 using an electron-accelerator irradiation process combined with purified Radium-225 sources. NorthStar announced commercial-scale production of the isotope in January 2026. The DMF acceptance establishes NorthStar as a regulatory-ready supplier for targeted alpha therapies, supporting partners from clinical development through commercialisation. The company also produces copper-67 and operates a radiopharmaceutical contract development and manufacturing organisation.

NorthStar: LCT plus osimertinib boosts PFS in metastatic EGFR+ NSCLC. Combining local consolidative therapy with osimertinib enhances progression-free survival in metastatic EGFR-mutant non-small cell lung cancer patients. The addition of local consolidative therapy (LCT) to osimertinib (Tagrisso) significantly improved progression-free survival (PFS) vs osimertinib alone in patients with metastatic EGFR-mutant non - small cell lung cancer (NSCLC), even in the setting of polymetastatic disease, according to data from the phase 2 NorthStar trial (NCT03410043) presented during the 2025 ESMO Congress.[1] The median PFS with osimertinib plus LCT (n = 56) was 25.3 months (95% CI, 19.4-45.0) vs 17.5 months (95% CI, 14.5-24.3) with osimertinib alone (n = 63), translating to a 34% reduction in the risk of disease progression or death (HR, 0.66; 95% CI, 0.50-0.87; 1-sided log rank P = .025). When broken down by EGFR mutation subtype, among those with exon 19 deletions who received osimertinib plus LCT (n = 34), the median PFS was 39.8 months (95% CI, 25.4-58.7) vs 22.4 months (95% CI, 17.0-35.7) with osimertinib alone (n = 44; HR, 0.57; 95% CI, 0.40-0.82). In those with exon 21 L858R mutations, the median PFS with osimertinib plus LCT (n = 19) was 19.0 months (95% CI, 15.4-36.6) vs 11.0 months (95% CI, 6.4-20.9) with osimertinib alone (n = 22; HR, 0.60; 95% CI, 0.39-0.92). Within those who had no more than 3 metastases at randomization, those given osimertinib plus LCT (n = 24) experienced a median PFS of 33.1 months (95% CI, 23.9-not applicable [NA]) vs 22.4 months (95% CI, 12.5-NA) with osimertinib monotherapy (n = 26; HR, 0.67; 95% CI, 0.43-1.03). In those with more than 3 metastases, osimertinib plus LCT (n = 32) led to a median PFS of 19.7 months (95% CI, 15.4-48.3) vs 15.9 months (95% CI, 13.8-23.9) with single-agent osimertinib (n = 37; HR, 0.70; 95% CI, 0.50-1.00). Complete LCT was achieved in 59% of patients with polymetastatic disease at baseline; these patients experienced a median PFS of 27.9 months (95% CI, 16.6-48.3); those who received partial LCT had a median PFS of 14.5 months (95% CI, 10.2-21.6). "These findings support osimertinib plus LCT as a safe and effective strategy to extend disease control and delay systemic progression in advanced EGFR-mutant NSCLC," Yasir Y. Elamin, MD, said in a presentation of the data during the meeting. Elamin is an assistant professor in the Department of Thoracic/Head and Neck Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, in Houston. What unmet need did the NorthStar study seek to address? The majority of patients with metastatic EGFR-mutated NSCLC who receive treatment with EGFR TKIs experience resistance and progressive disease. For patients with oligometastatic disease, LCT with radiotherapy or surgery has boosted outcomes. Although it has been hypothesized that pairing LCT with EGFR TKIs such as osimertinib could lead to the elimination of resistant clones and defer systemic progression, there is no prospective, randomized evidence pertaining to the role of this approach, Elamin noted. What was the design of the NorthStar trial in egfr-mutated NSCLC? The multicenter, randomized, phase 2 trial[1,2] enrolled patients with locally advanced or metastatic NSCLC who had measurable disease, an ECOG performance status no higher than 1, and TKI-naive EGFR exon 19 deletions or L858R mutations, or acquired T790 mutations without prior exposure to a third-generation TKI. After receiving induction osimertinib for 6 to 12 weeks, those without progressive disease (n = 120) were randomly assigned 1:1 to receive osimertinib or osimertinib plus LCT, with EGFR TKI given until progressive disease or intolerable toxicity. Patients were stratified based on if they were TKI naive or received a prior first- or second-generation TKI (yes vs no), number of metastases (<=3 vs >3), had a partial response (PR) or stable disease (SD) to induction osimertinib, and presence of brain metastases (yes vs no). LCT modalities (n = 56) included radiation (58.9%), surgery (32.1%), and both (9%). Among the 23 patients who underwent surgical procedures (n = 23), 78.3% received lobectomy, 8.7% had wedge resection, 4.3% had lobectomy and wedge resection, 4.3% had segmentectomy, and 4.3% had adrenalectomy. Radiation modality (n = 50) included volumetric modulated arc therapy or intensity modulated radiation therapy (56%), stereotactic body radiation therapy (30%), and 3D conformal or 2D conformal (14%). The primary end point of the study was PFS, and secondary end points comprised safety of the combination, overall survival, PFS in those with up to 3 metastases, and PFS in those who did not have exposure to TKIs. Elamin noted that with 120 patients undergoing randomization, the study had 80% power to detect an 8-month improvement in median PFS with a 1-sided type I error of 0.1. Leveraging O'Brien-Fleming outer test boundaries, the 1-sided Z-score boundary for rejecting the null hypothesis was - 1.316, which corresponds to a P value of .094. HR was evaluated using the Cox proportional hazard model, and PFS was calculated from the time that osimertinib was initiated to the date of disease progression or death using the Kaplan-Meier survival method. What should be known about the patient population of NorthStar? The median patient age was 64 years (range, 31-82) in the osimertinib-alone arm (n = 63) and 66 years (range, 40-88) in the osimertinib/LCT arm (n = 56). More than half of patients were women (66.7% vs 66.1%, respectively). In the osimertinib-alone arm, 66.7% of patients had EGFR exon 19 deletions, 28.5% had exon 21 L858R mutations, and 4.8% had T790M mutations (with L858R or exon 19 deletion); in the osimertinib/LCT arm, these respective rates were 57.1%, 39.3%, and 3.6%. Most patients were TKI naive (95.2% vs 96.4%), had more than 3 metastases at baseline (71.4% vs 69.6%), and greater than 3 metastases at randomization (58.7% vs 57.1%). More than half of patients in both arms did not have brain metastases (63.5% vs 62.5%). In the osimertinib monotherapy arm, 68.3% of patients experienced a PR to induction osimertinib, and 31.7% had SD; in the osimertinib/LCT arm, these respective rates were 71.4% and 28.6%. Eighty-four patients had polymetastatic disease at baseline. Of these patients, 29% had 0 to 5 metastatic lesions, 43% had 6 to 10 lesions, and 29% had more than 10 lesions. "Pleural effusion [27%] and lymphangitic spread [14%] were common, reinforcing that this is, indeed, a real-world population with a heavy disease burden," Elamin underscored. What was learned about the safety profile of osimertinib plus LCT? In the osimertinib/LCT arm (n = 56), the most common treatment-related adverse effects (AEs) included skin disorders (grade 1-2, 64.4%; grade 3, 1.8%), paronychia (57.6%; 0%), fatigue (55.3%; 0%), diarrhea (46.4%; 3.6%), dry skin (33.9%; 0%), dyspnea (30.3%; 0%), cough (28.6%; 0%), musculoskeletal pain (27.1%; 0%), nausea or vomiting (16.9%; 0%), thrombocytopenia (16.6%; 1.8%), anorexia (16.1%), constipation (14.3%; 1.8%), dysphagia (12.5%; 0%), transaminitis (11.9%; 0%), anemia (10.7%; 0%), leukopenia (10.7%; 1.8%), pleural effusion (10.7%; 1.8%), pneumonitis (10.7%; 1.8%), and hyponatremia (8.9%; 7.1%). LCT-specific AEs included pneumonitis (grade 1, 1.8%; grade 2, 8.9%; grade 3, 1.8%), dyspnea (26.8%; 3.6%; 0%), arterial injury (0%; 0%; 1.8%), empyema (0%; 0%; 1.8%), esophagitis (1.8%; 1.8%; 0%), and dysphagia (12.5%; 0%; 0%). No grade 4 or 5 LCT-related AEs occurred. "No excess toxicity was observed - in particular, there was no increased rate of pneumonitis beyond that expected with thoracic radiation," Elamin concluded. Disclosures: Elamin disclosed receipt or advisory fees from AstraZeneca, Eli Lilly, Novartis, Sanofi, Takeda, BMS, Nuvation, Mirati, Merus, Tahioo, BluePrint Medicines, Catalyst Pharmaceuticals, Johnson & Johnson, and Kestrel Therapeutics; and research support (institution) from AstraZeneca, Takeda, Nuvation, Nuvalent, Merus, Tahioo, Telligene, and Ellipses. 1. Elamin YY, gandhi SJ, antonoff MB, et al. NorthStar: A phase II randomized study of osimertinib (osi) with or without local consolidative therapy (LCT) for metastatic EGFR-mutant non-small cell lung cancer (NSCLC). Presented at: 2025 ESMO Congress; october 17-21, 2025; berlin, germany. Abstract LBA72. 2. Osimertinib, surgery, and radiation therapy in treating patients with stage IIIB or IV non-small cell lung cancer with EGFR mutations, NORTHSTAR study. ClinicalTrials.gov. Updated june 11, 2025. Accessed october 17, 2025. Stay up to date on practice-changing data in community practice.