Orano Med, a clinical-stage biotechnology company pioneering radioligand therapies in oncology, has inaugurated a significant expansion of its main Research and Development Center in Plano, Texas. The $5 million investment adds approximately 11,000 square feet to the facility, marking a strategic milestone in the company's development of lead-212 (212Pb) targeted alpha therapies for cancer treatment.
Facility Enhancement Doubles Production Capacity
The expansion encompasses around 5,000 square feet of new laboratory space and 5,500 square feet of additional office space, representing a 50% increase compared to the pre-existing facility. Most notably, the enhancement doubles the Good Manufacturing Practice (GMP) production capacity for early clinical trial supply, addressing the growing demand for lead-212 based drug candidates.
"The expansion of our R&D center enhances our ability to develop lead-212-based radioligand therapies by giving our teams the resources they need to advance a growing pipeline of drug candidates through to the clinic," stated Julien Torgue, Chief Scientific Officer of Orano Med. "With an integrated platform, cutting-edge equipment and a focused scientific strategy, we are well positioned to support both our internal developments and collaborations with partners."
Integrated Platform Supports Full Development Cycle
The facility operates as a fully integrated R&D platform, combining cutting-edge equipment with an experienced team to advance next-generation cancer therapies. The company can conduct the complete range of preclinical development studies onsite, including in vivo studies and Chemistry, Manufacturing and Controls (CMC) studies. This integrated approach ensures rapid and reliable transition from research to clinical phases.
The center accommodates both in-house research programs and collaborative developments with biotech and pharmaceutical partners. Beyond its primary therapeutic development mission, the facility serves as a production hub for lead-212 based drug candidates for early-stage clinical trials in the United States.
Clinical Progress and FDA Recognition
Orano Med's clinical pipeline has gained significant regulatory recognition, with AlphaMedix, the company's most advanced asset in development for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), receiving Breakthrough Designation from the FDA in 2024. The company is advancing several potential treatments using 212Pb combined with various targeting agents through clinical and preclinical studies.
"This expansion marks an important step in Orano Med's growth at our Plano site, which has played a key role since the inception of the company 15 years ago," noted Arnaud Lesegretain, President and Chief Executive Officer of Orano Med. "It reinforces our world-class R&D capabilities in the U.S. and strengthens our ability to deliver innovative targeted alpha therapies by supporting early-stage development in a fully integrated environment."
Targeted Alpha Therapy Mechanism
The facility's research focuses on targeted alpha therapy (TAT), which combines biological molecules' ability to target cancer cells with the short-range cell-killing capabilities of alpha-emitting radioisotopes. Alpha decay involves the emission of a helium nucleus (alpha particle) with very high linear energy transfer and a range emission of only a few cell layers, resulting in irreparable double strand DNA breaks in cells adjacent to the area of alpha emission.
This approach delivers increased cytotoxic potential toward cancer cells while limiting toxicity to nearby healthy cells. Alpha emitters are considered among the most powerful payloads available for targeted therapies, making lead-212 a particularly promising therapeutic radioisotope.
Strategic Growth and Global Expansion
The team at the Plano facility has doubled over the past four years, reflecting the company's rapid growth and expanding pipeline. During the inauguration ceremony, Orano Med unveiled the facility's new designation as the Drug Development and Preclinical Unit (DDPU) – George de Hevesy Center, honoring the Nobel Prize-winning chemist who pioneered the use of radioactive tracers.
Orano Med maintains 212Pb manufacturing facilities, laboratories, and R&D centers in both France and the United States. The company is expanding its GMP manufacturing capacities for 212Pb radiolabeled pharmaceuticals across North America and Europe, building a unique, independent, and fully integrated industrial platform to serve global patient needs.
