Supply issues are a “major concern for the whole industry and for the medical community as well, because they see targeted radiotherapy as a very promising field with very interesting results in the clinic, but they are concerned that drugs may not be available for a large number of patients, and it is a legitimate concern,” Orano Med SAS CEO Julien Dodet said. Companies such as Orano, Fusion Pharmaceuticals Inc. and Telix Pharmaceuticals Ltd. are working to meet those supply challenges.
Radiopharmaceuticals require sophisticated infrastructure, with just-in-time radioactives delivered to patients who must isolate while receiving the therapy. Quality control and numerous layers of regulation makes for a daunting space to enter. Although the demand for medical isotopes is growing, the facilities that can make these products are aging, and one of the major facilities globally has already come offline. Next steps for the industry will be to solve supply and regulatory challenges as clinical trial data start to differentiate therapies in the pipeline.
The Biden administration has released the National Cancer Plan, a framework that expands and builds on the Cancer Moonshot program which came into being in 2016. The National Cancer Plan includes a strategies section that calls for development of new methods for detecting cancer and new imaging technologies for early cancer detection, just two provisions that would seem to portend good times ahead for companies that manufacture these products.
The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices.
The radiopharma field has garnered increasing attention in recent years due to big-ticket deals like Bayer AG's $2.9 billion acquisition of Algeta ASA and Novartis AG's nearly $6 billion spent on buying Advanced Accelerator Applications SA and Endocyte Inc. As a result, competition is ratcheting up and pipelines are exploding with new combinations of different drugs. The global radiopharmaceuticals market was estimated to be valued at $6.7 billion in 2020, a number expected to reach $11.5 billion by 2027, according to a 2022 William Blair report.
If its challenges can be overcome, radioligand therapy is poised to change the way many cancers are treated. It is also likely to become an example of how scientific advances, once they are translated successfully, can enable further insights in a bench-to-bedside-to-bench loop. David Piwnica-Worms, professor and chair of cancer systems imaging at The University of Texas MD Anderson Cancer Center, predicted that as radioligand therapy expands, many questions will be answered about both radiation biology and the interaction of radiation with the immune system more specifically.
After spending decades developing targeted chemotherapy and bringing a dozen or so compounds into the clinic, Fusion Pharmaceuticals Inc. Chief Scientific Officer Christopher Leamon switched careers to focus on radio-oncology because he saw the need for “a really strong bomb to target cancer to get it to respond.” That was radiotherapy, said Leamon, who was one of the scientific founders of Endocyte Inc., which Novartis AG acquired.
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.
Genialis Inc. reeled in $13 million in a series A financing co-led by Taiwania Capital and Debiopharm Innovation Fund. The funds will be used to build out the company’s store of clinically validated biomarker models for individualized cancer diagnosis.
The Gustave Roussy cancer center, specializing in cancer treatment, and its technology transfer subsidiary Gustave Roussy Transfert, reported the creation of startup Orakl SA, which develops a technology for modeling cancer tumors called the patient tumor avatar. Orakl leverages a unique collection of patient tumor avatars, combining biological and clinical data to fuel the therapeutic arsenal to fight cancer.
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