Telix Pharmaceuticals, an Australian radiopharmaceutical company, has developed a new radionuclide generator that could address challenges in scaling the commercial supply of lead-212 isotope-based therapies.
The company announced that it has successfully developed and validated the technology, with the first production of the radioactive isotope now completed.
Following the announcement, shares in Telix, listed on the Australian Securities Exchange (ASX), rose 1.3% before trading began. The company now holds a market capitalization of $5.66 billion.
Lead-212 is a promising radioactive isotope used in targeted alpha therapy (TAT), a cancer treatment alternative to beta-particle therapies. This approach has shown effectiveness in treating certain cancers. Lead-212 is produced through the decay of thorium-228 in a generator, which acts like a nuclear battery, producing daughter radionuclides by losing energy from a parent radionuclide.
While lead-212 can be produced in small amounts in laboratory settings, scaling up its production has been difficult with current generator technologies. In addition to these commercial-scale challenges, lead-212 has a shorter half-life than actinium-225, another commonly used alpha-emitter, with a half-life of 10.6 hours compared to nearly 10 days for actinium-225.
Telix’s IsoTherapeutics team developed the new generator using a sealed thorium-228 source. The company claims that its lead-212 production yields higher levels of radioactivity, greater yield, and an extended shelf life compared to existing generators.
The new generator, designed for automation and high-throughput, can produce enough lead-212 for up to 60 clinical doses, with potential for further scalability. Elution, the process of extracting the radioactive daughter nuclide, is a key feature of this production method.
Telix has not disclosed the specific dimensions of the generator but emphasized that the production setup is designed to integrate within its global manufacturing and distribution networks. Recently, Telix expanded its commercial channels with the $250 million acquisition of RLS Radiopharmacies in September 2024, gaining access to 31 radiopharmacies across 18 U.S. states.
Chad Watkins, Telix’s isotope strategy general manager, said, “A lead-212 generator that produces minimal waste and fits within the current radiopharmacy footprint is a significant advancement in the production of this alpha-emitting therapeutic radioisotope. It opens up new possibilities for large-scale production and aligns this promising alpha isotope with a range of targeting agents.”
The United Kingdom’s National Nuclear Laboratory (UKNNL) has highlighted the potential of lead-212 for cancer treatment but also noted the supply challenges. In partnership with Medicines Discovery Catapult, UKNNL is using government funding to reprocess uranium waste into usable lead-212 medical isotopes.
“Other countries are already developing these treatments, but the UK currently lacks a sustainable supply chain for radiopharmaceuticals to ensure availability for UK patients,” UKNNL said in a statement. The lab’s goal is to eventually enable commercial production and routine use within the National Health Service (NHS).
The demand for lead-212 therapies is growing. AdvanCell, a company developing a lead-212-based therapy, recently raised $112 million. Additionally, RadioMedix and Orano Med’s AlphaMedix, another targeted alpha therapy using lead-212, secured a $110 million licensing deal with Sanofi in September 2024. Telix also raised $398 million in July 2024 to support its diagnostic imaging and cancer therapy programs.
While significant investments are being made in the sector, including billion-dollar deals from companies like Eli Lilly and AstraZeneca, supply chains are facing pressure. Isotope producers, including those making actinium-225, continue to struggle with scaling up their production capacity to meet market demands.
