Could you start by introducing yourself and your role at Orano Med?
I hold a Ph.D. and work for Orano Med, a subsidiary of the Orano Group, an international entity focused on nuclear fuel and services. Orano Group's strategic venture into the pharmaceutical sector was largely influenced by a fortunate discovery of a thorium stockpile in southern France that resulted from a uranium mining project. This stockpile has proven to be a crucial asset for our entry into radiopharmaceuticals, particularly through the development of lead-212, a promising medical isotope for killing cancer. Our approach leverages this unique resource, setting us apart in the industry as we control our complete supply chain, negating the need for nuclear reactors or particle accelerators to supply our medical isotope.
Could you describe the current pharmaceutical projects at Orano and how they integrate with the group’s nuclear technology expertise?
Our pharmaceutical endeavors focus solely on lead-212. Despite the potential of other isotopes, we capitalize on our strategic advantage with lead-212 for radioligand therapies, which involve a targeting molecule, a radioactive isotope, and a linker molecule. By owning Macrocyclics, a leader in linker molecule production, we enhance our capability to innovate within the radiopharmaceutical space.
Our leading drug candidate, AlphaMedix, developed in partnership with Radiomedix, targets neuroendocrine tumors using lead-212 and is similar in structure to Novartis's FDA-approved Lutathera.
This project not only illustrates our commitment to cutting-edge cancer treatment, but also showcases our ability to manage the entire production lifecycle from isotope procurement to final drug product manufacturing.
Regarding collaborations and partnerships, could you highlight any significant relationships Orano has established in the pharmaceutical industry?
Our key partnership for the AlphaMedix product is RadioMedix. Additionally, we have significant collaborations with major players like Roche and Molecular Partners, focusing on developing products that are advancing toward clinical trials. Our strategy involves both internal development and external partnerships, ensuring a robust pipeline of innovative radiopharmaceuticals. While our manufacturing capabilities are likely to remain with Orano Med, we remain open for partnerships that align with our strategic goals, particularly those that can benefit from our unique isotope resources.
What are the main regulatory challenges Orano faces, and how are you addressing them?
The regulatory landscape for therapeutic radiopharmaceuticals is very important, especially since our treatments involve alpha-emitting isotopes, which are potent for killing nearby cells. For AlphaMedix, we are currently in the clinical trial phase, adhering closely to FDA guidelines to ensure compliance and safety in our processes. Additionally, our breakthrough designation from the FDA for AlphaMedix accelerates our interactions with regulators, enhancing our ability to navigate this area effectively.
Can you elaborate on how Orano ensures sustainability and safety in its pharmaceutical operations, particularly concerning radioactive materials?
Safety is paramount in our operations, both for our workers and the environment. As the radiation safety officer for the ATLab Indianapolis facility, I oversee stringent safety protocols at our facilities, which are designed around robust radiation safeguards such as extensive monitoring, specialized ventilation, and protective engineering controls. Our facilities are equipped with advanced radiation shielding and monitoring technologies to ensure that exposure levels remain well within safe limits. We handle isotopes responsibly, with most decaying to safe levels quickly, and we engage professional services for the disposal of waste.
Lastly, looking forward, what is Orano's vision for its role in the pharmaceutical industry, particularly in radiopharmaceuticals?
Orano is uniquely positioned to lead in the radiopharmaceutical sector, thanks to our robust supply of lead-212 and our comprehensive control over the production process. Our vision is to scale up our operations significantly, aiming to produce hundreds of doses daily across multiple facilities worldwide. This expansion will not only increase our capacity, but also enhance our ability to deliver innovative cancer treatments globally. As we progress, we anticipate our platform will include a diverse portfolio of drugs tailored to treat various cancers, showcasing our overall commitment to advancing healthcare through nuclear technology.
