PASADENA, Calif.—Fuzionaire Diagnostics has forged a partnership with Tokyo-based radiopharmaceutical Japan Medical Isotope Technology Development (JAMIT) to launch Fuzionaire Radioisotope Technologies (FRIT) and commercialize Fuzionaire Dx’s technology in Japan. The strategy includes expanding Fuzionaire Dx’s fluorine-18 radiolabeling platform through partnerships with Japanese pharmaceuticals and research institutions to explore new possibilities in alpha-emitting radiotherapeutics for cancer treatment. Dr. Hiroshi Nakashita will serve as FRIT’s CEO.
This bold and ambitious move comes eight years after the March 11, 2011 Fukushima disaster, when the coast of Japan was struck with an earthquake followed by a tsunami which damaged several nuclear reactors, igniting Japan’s fears of anything ‘nuclear.’
In October 2011, the Japanese Cabinet stated that “Public confidence in safety of nuclear power was greatly damaged” by the disaster and called for a reduction in the nation’s reliance on nuclear power.
In September 2012, Prime Minister Yoshihiko Noda acknowledged that the vast majority of Japanese support the “zero option on nuclear power,” and Noda announced plans to make the country nuclear-free by the 2030s.
But Fuzionaire Chief Science Officer Anton Toutov told colleagues that the chemistry platform dramatically accelerates radiopharmaceutical discovery and improves manufacturing of radiolabeled molecules. This fundamentally changes the way in which researchers and clinicians are able to detect and treat disease.
“With respect to disease diagnosis, our chemistry-driven platform can radiolabel molecules in record-breaking speed and at ambient temperatures,” Toutov tells DDNews. “We’re using this technique to generate a wide variety of novel radiopharmaceuticals that could offer clinicians a way to detect, localize, diagnose and monitor more diseases—such as cancers, viruses and neurodegenerative and cardiovascular diseases—earlier and with unprecedented precision.”
“With respect to drug discovery, radiolabeled molecules can be used to provide useful in-vivo information related to how a drug of interest is working and whether it’s hitting the right targets—and avoiding the wrong ones—in the body,” he adds. “It could also be used to evaluate patient response to various treatments. Taken together, these tools have the potential to accelerate the advancement of effective drugs to the market.”
“Fuzionaire’s technologies open up new possibilities for disease diagnosis and treatment,” Nakashita says. “After years of delay in research and development in these areas due to the political landscape, we are thrilled to have the technology and talent to bring necessary advancements to our country.”
Dr. Makeo Morooka is co-founder and CEO of JAMIT, and founder of the Japan Foundation of Medical Isotope Development (JAFMID), which seeks to promote population health and develop Japan’s medical industry by addressing technological, manufacturing and regulatory issues in medical isotope development.
“After the Fukushima disaster, new restrictions were implemented in Japan that impacted nuclear medicine,” noted Morooka, a special advisor to FRIT. “We believe JAMIT’s and Fuzionaire Diagnostics’ joint efforts through Fuzionaire Radioisotope Technologies could accelerate the critical development of radiopharmaceuticals in Japan and add to the conversation about the importance of medical isotope technologies in Japan and the world.”
Nick Slavin, CEO of Fuzionaire Dx, says, “In Japan, challenges with nuclear medicine are top of mind, but also extremely pertinent to public health. We’re thrilled to be working with such accomplished and experienced collaborators who recognize the opportunity to improve technologies that can directly impact the health of the country.”
“Our patented HetSiFA compositions, which are synthesized using our alkali metal catalysis, can incorporate radioisotopes into drug compounds and disease-targeting ligands at record-breaking speed,” he continues. “We make it possible to rapidly produce a broad range of fluorine-18 radiopharmaceuticals for PET imaging using a single catalyst-driven, disease-agnostic platform. In addition to biological imaging for drug discovery and clinical applications, our chemistry is being applied to the development of novel anti-cancer radiotherapeutics.”
Slavin comments that Fukushima “sparked a lot of fear about anything involving radiation.”
“After Fukushima, the Japanese government instituted many regulations, including ones on seismic resistance standards of nuclear reactors,” he explained. “These standards are difficult—if not impossible—to meet, and they are very costly. Some reactors that had been or could be used to create medical isotopes were abolished, forcing the field to look for different solutions, including using commercial reactors that can meet the new standards.”
According to Slavin, the political challenges and opportunities are two-fold: One, overcome the negative association with “nuclear” through stringent best-practices and education; and two, demonstrate the power and opportunity of nuclear medicine to unlock a new era of care.
Fuzionaire’s platform enables a new branch of catalysis that is based on earth-abundant metals like potassium and sodium which operate at low temperatures and pressures, Slavin points out. These catalysts are up to 10,000 times cheaper than state-of-the-art precious metal catalysts and have the potential to address a wide range of previously unsolved problems across industries, including in medicine, energy and materials.
“This technology lets us radiolabel—that is, attach a radioactive isotope to a wide variety of molecules,” Slavin says. “Our chemistry makes possible new precision radiopharmaceuticals for PET imaging, new ways to use radioisotopes and PET scans to accelerate the discovery and development of drugs and eventually, have safer precision radiotherapies for cancer.”
Slavin is optimistic about the future of nuclear medicine in Japan. For him, 2020 “is about establishing a pipeline of novel radiopharmaceutical candidates for diagnosis and treatment of various cancers. This will involve identifying some of the most powerful biological assets available for cancer targeting and combining these with our catalysis and radiochemistry platforms.”