212Pb-AR-RMX

VILLEJUIF, France--(BUSINESS WIRE)--Orano Med, a subsidiary of the Orano Group specializing in nuclear medicine, today provided an overview of its activities and progress made during the first half of 2026, along with a business outlook for the remainder of the year. The update covers the company's key areas of operations, including corporate developments, clinical progress and preclinical research as well as industrial activities, and outlines priorities and initiatives for the second half of 2026. Frederic Desdouits, CEO of Orano Med commented: “Since joining Orano Med in April, I've seen strong progress across all key areas of our business. In the past six months, we’ve significantly expanded our clinical pipeline, with four active lead-212 clinical studies underway, conducted by Orano Med or our partners. With our newly inaugurated R&D center in France complementing our US research hub, we have capability to further accelerate drug candidate development. On the industrial side, we are ramping up thorium-228 production at our pilot facility, and the EUR 125 million loan from the European Investment Bank will support continued investment into our industrial platform's development. Our GMP facilities, the ATLabs in Indianapolis and Valenciennes, remain on schedule to supply clinical doses in the US and Europe. H1 2026 marked a period of meaningful progress, and we look forward to building on this momentum.” Corporate highlights In April, Frederic Desdouits was appointed CEO of Orano Med , bringing extensive experience in the pharmaceutical and biotechnology industries. A member of Orano Med's Governing Board since 2022, he joined at a pivotal moment for the company, with the mission to accelerate clinical development while advancing the build-out of its industrial platform for commercial-scale production of lead-212-based treatments. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); On May 18, Orano Med officially inaugurated its new global headquarters and R&D laboratories in Villejuif , located within the Paris Saclay Cancer Cluster. The 700 m² site hosts 35 employees, both corporate functions as well as its first R&D center based in France, designed to accelerate the discovery and clinical development of lead-212-based targeted alpha therapies. In July, Orano Med announced the appointment of Caroline Germa, Jean-Pierre Bizzari and Philippe Archinard as independent members of the Governing Board dedicated to the company’s biotech activities. They will work alongside Fabrice Chouraqui, a member of the Governing Board since 2022, whose mandate continues. With deep expertise in the biotech and pharma sector, they further strengthen the Board’s ability to support Orano Med’s development. R&D highlights In May, along with its new headquarters, Orano Med opened its first R&D center in France within the Paris Saclay Cancer Cluster , a French government initiative launched as part of the “France 2030” program to establish a center of excellence for innovative cancer treatments. The state-of-the-art R&D laboratories will be dedicated to the development of peptide vectors for lead-212-based targeted alpha therapies (TAT) to accelerate the identification of novel drug candidates and their progression from early-stage research through clinical development. Alongside its research center in Texas, US, both R&D locations will complement each other, significantly strengthening Orano Med’s in-house discovery and development capacities. Clinical portfolio highlights Four clinical trials with Orano Med’s lead-212 targeted alpha therapy are currently ongoing in the US across different targets and various cancer types. Orano Med has completed a comprehensive review of the future clinical development strategy for its lead medicine AlphaMedix™, as a potential treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) expressing SSTR (somatostatin receptors). Orano Med informed its partners Sanofi and RadioMedix, as well as health authorities and leading clinical experts, that it has finalized a new clinical study protocol to initiate the next AlphaMedix trial toward the end of 2026. The protocol addresses the risk of delayed adverse events, which were observed in some patients enrolled in the previous phase 1 and phase 2 studies. The new study design aims to optimize the benefit-risk pro the drug candidate, preserving its efficacy while addressing these adverse events. AlphaMedix phase 2 efficacy data, presented at ESMO 2025 , demonstrated a 60% overall response rate in PRRT-naive GEP-NET patients. GEP-NETs are rare cancers with unmet needs where patients need additional treatment options. Orano Med's second clinical program, targeting GRPR (Gastrin-Releasing Peptide Receptor) in solid tumors (NCT05283330), is advancing to the next stage of development in the US. The phase 1/2a study is now enrolling into multiple-dose cohorts to establish the recommended phase 2 dose (RP2D). The program employs a matched-theranostic pair, utilizing ²⁰³Pb-DOTAM-GRPR1 for imaging followed by up to four therapeutic doses of ²¹²Pb-DOTAM-GRPR1. In parallel, preparation for a Clinical Trial Application (CTA) in Europe is underway, with a regulatory approval anticipated in Q4 2026. GRPR is overexpressed across many cancer types, such as colorectal cancer, breast cancer, prostate cancer, cervical cancer and glioblastoma, representing areas of high unmet medical need. Orano Med and Molecular Partners recently announced the dosing of the first patients in a phase 1/2a clinical study targeting DLL3 (delta-like ligand 3) in small cell lung cancer and other neuroendocrine tumors (NCT07278479). Sponsored by Molecular Partners and conducted in the US, the study evaluates the safety and efficacy of MP0712, a DARPin radiolabelled with lead-212. DARPins are a novel class of custom-built protein therapeutics derived from natural binding proteins, designed for powerful and highly selective tumor cell targeting and for precise delivery of radioisotopes. SCLC is one of the most aggressive cancer types, with a five-year overall survival rate below 10%, underscoring the critical need for effective treatment options. Another Phase 1 clinical trial, sponsored by Roche (NCT07416552), is actively recruiting patients with metastatic colorectal cancer expressing CEA (carcinoembryonic antigen). Jointly developed by Orano Med and Roche, the study evaluates an innovative “two-step pretargeted radioimmunotherapy” (PRIT) approach, in which two complementary bispecific antibodies first pretarget the tumor before capturing chelated lead-212 to destroy cancer cells. Orano Med is responsible for manufacturing chelated lead-212 used throughout the clinical program. Industrial platform highlights On July 1, the European Investment Bank and the Orano Group signed a EUR 125M credit line to finance the development of Orano Med and its industrial infrastructure, notably the construction of the ATEF facility, located in Bessines-sur-Gartempe, France. ATEF is the world’s first industrial facility dedicated to the large-scale production of thorium-228, a precursor of lead-212, based on our proprietary stock of thorium-232. Construction is expected to advance throughout the second half of 2026, with the building completed in H2 2027. During the first half of 2026, the Laboratoire Maurice Tubiana (LMT) industrial pilot facility, also in Bessines-sur-Gartempe, France, made substantial progress. A capacity expansion project is on track to significantly increase thorium-228 production, enabling LMT to supply the lead-212 precursor isotope for all ongoing and planned clinical trials conducted by Orano Med and its partners in France and the US. Orano Med controls the entire value chain of pharmaceutical production of lead-212 TAT and an industrial network is being progressively deployed to supply clinical study programs, building on the company’s long-standing and proven track record in GMP-compliant manufacturing. To date, Orano Med has produced hundreds of therapeutic doses and brings a deep experience to ensure the commissioning and qualification of the ATLab Valenciennes, in France, and the ATLab Indianapolis, in the US, scheduled by year end. About Orano Med Orano Med is a subsidiary of the Orano Group. Orano Med is a clinical-stage biotechnology company that develops a new generation of targeted therapies against cancer using the unique properties of lead-212 ( 212 Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha Therapy (TAT). Leveraging its unique and secured access to 212 Pb, the company is developing several 212 Pb-based radioligand therapies combined with various targeting agents. Orano Med has 212 Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently expanding its GMP-manufacturing capacities for 212 Pb radiolabeled pharmaceuticals in North America and Europe. Contacts Press Contact Regina Jehle Head of Communications and Public Affairs communication@oranomed.com Tel.: +33 6 74 56 11 31