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In March 2017, the Strategy Committee at the Paul Scherrer Institute (PSI) gave its green light for a joint initiative with PARK INNOVAARE to join in realizing the Nuclides for Life project and its first spin-off, Life Diagnostics. The goal is to develop a platform for the supply and development of radiopharmaceuticals for diagnostics and therapies.
Two years ago, scientists, physicians and business developers across Switzerland realized the need for a centralized and focused approach to radiopharmaceutical research and its clinical application in Switzerland. “Nuclides for Life, as we now call it,” explains Dr. Sebastian Schegk, who heads the project, “can reunite quite different units under one roof.” The unit Life Diagnostics, for example, will provide Swiss hospitals with much-wanted radio tracers and services, whereas several units under Therapy Ventures will explore novel directions for radio therapeutics with global partners. “We are quite advanced with Life Diagnostics,” says Professor Roger Schibli, Head of the Center of Radiopharmaceutical Sciences (CRS) at the PSI and ETH Zurich. “In just a few months, we will start with the production and distribution of our first diagnostic tracer.”
Precise diagnosis: first step towards a cure
Significant progress has been made in radiopharmaceutical sciences in the last decade to provide nuclear physicians with non-invasive imaging tools. Today, these tools are a cornerstone of precision diagnostics in such distinct areas as neurological disorders including Alzheimer’s, cardiac disorders or cancer. A major step forward in radio diagnostics was the shift from SPECT imaging techniques (Single Photon Emission Computer Tomography) to PET (Positron Emission Tomography). The focus today is on a very few radio nuclides for such PET examinations, more specifically 18F and 68Ga. All of them decay with short half-lives between one and two hours and must be prepared in regional centers for fast delivery to the diagnosis stations.
What is now needed is a new generation of radionuclides and more specific tracers for the diagnosis of various types of cancer. A nuclide is coupled to a tracer, which guides it to the target site. Such novel tracers are in development, and the CRS is at the forefront of that endeavor. But bringing them to the market requires lots of manufacturing expertise, regulatory know-how and an operational excellence that can serve the healthcare system with high reliability.
A success example of this new generation of tracers is a 68Ga-coupled PSMA ligand for the staging of advanced prostate cancer. But the Swiss launch of this much-wanted radio tracer has also revealed many operational and regulatory hurdles.
44Sc (Scandium) could change the market
“On our project two years ago, we were asked by the medical community to help with exactly such regulatory and operational issues, and we at the PSI felt obliged to contribute our vast expertise to the field,” says Dr. Christine Huber-Musahl from the PSI’s Technology Transfer Department.
The CRS possesses outstanding experience in the development and manufacturing of radio tracers; based on this experience, Life Diagnostics will establish a regular and substantial supply of radio diagnostics to the healthcare system. It will be ideally located in Villigen, in between the big urban centers of Switzerland and beyond.
For this service, Life Diagnostics will focus on 68Ga and 44Sc tracers. The use of Scandium in radio diagnostics is a proprietary PSI development. The CRS possesses a well-filled pipeline of such 44Sc tracers. With a half-life of 4 hours, Scandium is said to be the ideal radio nuclide for PET diagnostics. It offers enough time for delivery even across longer distances – but also more time for biologically highly relevant tracers to accumulate at the target.
“Set in the context of the Swiss Innovation PARK INNOVAARE, Nuclides for Life means the translation of science into commercial application in the very best sense,” continues Christine Huber-Musahl. Partners are invited to join.
Providing a new outlook for radio-therapy
Diagnostics will not be the only focus of Nuclides for Life. “Since the beginning of our project, the medical community has made it clear that therapy development needs an enforcement,” says Professor Schibli. In therapy, coupling nuclides to vectors, as the tracer ligands are called here, is even more demanding and requires full competence in pharmaceutical development. The CRS has this competence and the spin-off groups under Therapy Ventures will have access to it, as well as to the full radiopharmaceutical toolbox.
Currently, work is mostly being done with 177Lu-coupled vectors and several promising clinical studies are on their way. But the nuclide 177Lu is still a β- emitter. Nuclear physicians and researchers from the pharma industry ask for α emitters as ideal therapeutic nuclides. The likewise commercially impressive success of 223RaCl2 in Alpharadin (Bayer’s Xofigo©), or last year’s spectacular results with an 225Ac-PSMA-ligand against metastases of prostate cancer exemplify the impact such α emitters can have.
Sebastian Schegk adds, “The successes in radio nuclide therapies have awakened the interest of the research-driven pharma industry in the search for the next generation therapy concepts.” What is needed now is to establish a reliable supply chain of such highly-wanted, therapeutic nuclides. Several initiatives are working on it under the roof of Nuclides for Life.