Canadian firms make progress with radioisotope production

Researched and written by World Nuclear News – September 25, 2020

Ontario Power Generation (OPG), its subsidiary Laurentis Energy Partners, BWXT ITG Canada Inc and its affiliates yesterday said they are making “significant progress” towards the production of molybdenum-99 (Mo-99) at OPG’s Darlington plant. Darlington will be the first large-scale nuclear power station to produce the medical radioisotope, they said.

OPG announced in June 2018 that Darlington would produce Mo-99 for use in new technetium-99m (Tc-99m) generators designed by BWX Technologies Inc. Over the past 24 months, a team of more than 100 personnel at BWXT and Laurentis have designed specialised tooling to enable the production of Mo-99 at Darlington, and this is now being manufactured at BWXT’s facility in Peterborough, Ontario.

BWXT has also built a fabrication facility to produce Mo-99 components that will be delivered by the specialised tooling, which will be installed at Darlington. The tooling will deliver natural molybdenum into the Darlington reactor for irradiation, which will enable Darlington to become the first commercial operating nuclear reactor to produce Mo-99.

Mo-99 is used to generate Tc-99m, which is the world’s most widely used radionuclide for medical imaging. Both Tc-99m and the Mo-99 it is generated from have short half-lives and need to be used quickly once they are produced, so a constant, stable supply of them is needed. Mo-99 has primarily been produced by a limited number of research reactors, using enriched uranium targets.

“This advanced equipment is an example of how Laurentis is maximising decades of experience within the nuclear industry for the delivery of innovative solutions,” said Dominique Minière, president of Laurentis Energy Partners.

“We are well under way with the transformation of our nuclear medicine facility in Ottawa to be able to process Mo-99 and manufacture Tc-99m generators,” BWXT ITG President Martyn Coombs said. “These generators will be used to make radiopharmaceuticals for patients, and will help to resolve historical shortages of this vital product.”

OPG is in the process of refurbishing the four Candu reactors at the Darlington plant in a CAD12.8 billion (USD9 billion), 10-year project that will enable the station to operate for an additional 30 years. The first unit to undergo refurbishment – Darlington 2 – returned to service in June and work started on the refurbishment of unit 3 earlier this month.

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CNL Turns Its Attention to Next-Generation of Medical Isotopes

CHALK RIVER, Ontario, Oct. 31, 2019 (GLOBE NEWSWIRE) — Canadian Nuclear Laboratories (CNL), Canada’s premier nuclear science and technology organization, is pleased to announce that it is building on its 70-year history in medical isotope production and research to advance the availability and scientific understanding of actinium-225, a rare medical isotope that has shown great promise as the basis for new, cutting-edge cancer therapies. This was the message delivered earlier today by Mark Lesinski, CNL President and CEO, during a presentation at the International Atomic Energy Agency’s (IAEA) International Symposium on Trends in Pharmaceuticals (ISTR-2019) in Vienna.

During the talk, Lesinski discussed pre-clinical research CNL is conducting with leading Canadian research organizations to help enable medical treatments using actinium-225 to fight a wide spectrum of cancers and other diseases. This work is in addition to the successful joint trial production run of actinium-225 that CNL recently completed in partnership with TRIUMF, Canada’s particle accelerator centre, which could serve as a major leap forward in the availability of the rare isotope.

“Together, CNL and TRIUMF have successfully demonstrated the viability of our joint production and separation process, a major milestone that will make high-purity actinium-225 more widely available for research and clinical studies,” commented Mark Lesinski, President and CEO at CNL. “But our work goes beyond this exciting project. CNL has also entered into a number of different collaborative research agreements to develop drug delivery techniques and technologies around targeted alpha therapy, so we can help to realize the full potential of this promising new form of cancer treatment.”

With funding provided to CNL through the Federal Nuclear Science and Technology Work Plan administered by Atomic Energy of Canada Limited, the collaborative research agreements are being carried out together with the University of Saskatchewan, as well as University of Saskatchewan researchers whose projects are supported by the Sylvia Fedoruk Canadian Centre for Nuclear Innovation Inc. This work encompasses pre-clinical research to support the development of targeted radionuclide therapies for colorectal cancer, breast cancer (led by Dr. Humphrey Fonge, College of Medicine University of Saskatchewan), the human immunodeficiency virus (HIV) and invasive fungal infections (led by Dr. Ekaterina Dadachova, College of Pharmacy & Nutrition University of Saskatchewan). In addition to their production and processing agreement, CNL and TRIUMF are also conducting research related to chelation, an important bonding mechanism needed to bind the isotope to a peptide or antibody that specifically targets a diseased cell or tissue, ensuring it is delivered to the desired location in a patient’s body (led by Dr. Valery Radchenko).

An alpha-emitting isotope with a short half-life, actinium-225 can be used in this manner to more effectively target cancer cells, creating a revolutionary treatment that is extremely effective at killing cancer cells without doing damage to surrounding, healthy cells. Known as targeted alpha therapy, this new form of treatment has shown exciting potential in early studies with prostate cancer patients for whom conventional cancer therapies have not worked.

“Unfortunately the global shortage of this rare isotope has delayed important research into this promising new form of cancer therapy,” explained Lesinski. “So, our work at CNL with actinium-225 is two-fold: we’re not only collaborating with TRIUMF to produce larger quantities of the isotope, but we’re also conducting foundational research to help accelerate the development of medical applications that can harness its potential.”

Produced using TRIUMF’s high-energy cyclotron in Vancouver and processed at CNL’s Chalk River Laboratories in Ontario, the increased availability of actinium-225 is expected to be well received by the medical and pharmaceutical communities. According to Lesinski, the new joint production process is expected to increase global supplies to levels that could permit hundreds of thousands of treatments every year, a dramatic increase from current levels, which can only be used to enable a handful of treatments.

For more information on CNL, including its work in targeted alpha therapy, please visit www.cnl.ca.

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Cyclotron-based gallium-68 generator breaks production records

November 26, 2019 – Gallium-68 (68Ga) is a positron emitter that’s becoming established as a valuable diagnostic isotope, primarily for detection of neuroendocrine tumours (NETs). Such tumours do not metabolize glucose well – precluding their visualization via standard FDG-PET scans – but overexpress somatostatin receptors that bind, for example, to the PET agent 68Ga-Dotatate.

Currently, 68Ga is made using a germanium/gallium generator, in which 68Ga is created as its parent isotope 68Ge decays. Unfortunately, this approach only produces enough 68Ga for two or three patient scans per day. Canadian company ARTMS Products is developing an alternative technique, in which a low-energy cyclotron is used to create 68Ga from solid zinc-68 targets. The company has now demonstrated record breaking, multi-curie levels of 68Ga production.

“The primary challenge with germanium/gallium generators is that they can’t seem to make the generators fast enough, and when they do, the output is relatively limited,” explains Paul Schaffer, founder and CTO of ARTMS. “The generators make about one patient dose for each elution. So even if they run two or three per day, that’s only two or three patient doses per day, which is an expensive proposition for many centres.”

To address this problem, ARTMS developed the QUANTM Irradiation System (QIS), a 68Ga production scheme that includes enriched 68Zn targets, a transportation device that attaches onto the port of an existing medical cyclotron and a send-and-receive station that terminates inside a shielded workspace. Schaffer notes that the system is manufacturer-agnostic and can be installed on any major cyclotron brand.

The hardware enables a technician to load a non-radioactive 68Zn target into the transportation system. Automated pneumatics and robotics then move the target to the cyclotron’s target port, where it is irradiated for two hours by a proton beam. This proton irradiation generates 68Ga within the target via the 68Zn(p,n)68Ga nuclear reaction. The irradiated target is then brought back to the shielded space where the 68Zn can be extracted and purified for use in radiopharmaceuticals.

“What makes the ARTMS system unique is we’ve demonstrated that it can produce 68Ga at levels of 10 Ci – or 370 GBq,” says Schaffer. “This is 100 to 200 times more activity in a two-hour irradiation than a germanium/gallium generator can put out. This puts the problem not on the amount of gallium that you have but, with its 68 min half-life, the rush to use it all.”

He suggests that a hospital should to be able to produce about a day’s worth of 68Ga and scan several patients following a single cyclotron run. “And at the end of the day, you don’t have any 68Ge or long-lived by-products to deal with,” he notes.

The record-breaking 68Ga production was achieved at Odense University Hospital. The team there demonstrated multi-curie production of two radiopharmaceuticals: 68Ga-Dotatate (known as NETSPOT) and a prostate-specific membrane antigen (PSMA) radiopharmaceutical for imaging prostate cancer. The Odense team is now embarking on a validation study in preparation for regulatory submission.

“We have demonstrated the production level, we’ve demonstrated the chemistry and we’ve demonstrated that 68Ga quality is consistent with regulatory standards, but we have not yet received regulatory approval,” says Schaffer.

He explains that other centres worldwide are working with ARTMS to achieve regulatory approval for the QIS in their respective countries. “We have a system in Zurich and one in Wisconsin, and also have systems being installed in Japan, the UK, Costa Rica and Toronto,” he says. “I think it’s in everyone’s interest to get this approved as quick as possible.”

Schaffer notes that the new production technology is intended to supplement, rather than replace existing 68Ga generation methods. “There are going to be areas in the world that will continue to rely on reactor-produced isotopes. There will be areas where Ge-68 and Mo-99 generators just make sense,” he tells Physics World. “But there are many areas of the world that rely on cyclotron technology, and that’s where ARTMS wants to fit in, that’s our goal.”

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Chuck Conroy Appointed CEO of ARTMS

VANCOUVER, British Columbia-September 10, 2019 -ARTMS Products Inc., the global leader in the innovation and commercialization of novel technologies that enable cyclotron production of the world’s most needed medical radioisotopes, is pleased to announce the appointment of Charles S. Conroy R.Ph, MBA as its Chief Executive Officer.

Mr. Conroy brings to ARTMS more than 25 years of experience in the life sciences industry, including several significant senior positions within the radiopharmaceutical industry. Most recently Mr. Conroy was the General Manager of Jubilant Pharma where he was responsible for North American sales and operations. Prior to joining Jubilant, he was the Chief Operating Officer of PharmBlue LLC and has held leadership roles in various life sciences companies including Express Scripts, United BioSource Corporation, Covidien and Eli Lilly.

“I am excited to embark on this new journey as CEO of ARTMS, leading an exceptional organization, and expanding the commercialization of its innovative technology for the production of critical medical isotopes”, said Mr. Conroy. “ARTMS’ award-winning technology has the potential to revolutionize the nuclear medicine industry by enabling global access to cyclotron-produced medical isotopes. I look forward to building upon the company’s current successes and accelerating its growth.”

“We are very pleased to welcome Chuck Conroy as our new CEO. Chuck is a remarkable leader with an impressive track record of building marketing and sales strategies and comes with a wealth of experience scaling life sciences companies” said Steven Foster, Chairman of the Board of ARTMS. Mr. Conroy replaces Interim CEO, Dr. Kaley Wilson.

Mr. Conroy joins ARTMS at an exciting time in the expansion of the commercialization of the ARTMS QUANTM Irradiation System™. The QIS™ technology was developed in collaboration with scientists and clinical researchers from TRIUMF, BC Cancer, the Centre for Probe Development and Commercialization, and Lawson Health Research Institute and has already been deployed within a number of different OEM cyclotrons in major markets, including North America, Europe and Asia. It is a hardware and consumable system that provides for cost-effective, decentralized, and local production of important medical isotopes, including technetium-99m, gallium-68, zirconium-89 and copper-64. Having already proven the concept and clinical application for routine and high-yield production of technetium-99m, ARTMS continues to drive a paradigm shift from the current supply chain model and is moving into advanced commercialization of cyclotron-produced gallium-68, a much sought after and valuable isotope for medical imaging in prostate and neuroendocrine tumours.

In addition, ARTMS also announced that Mr. Len Ducker will join the Board of Directors of ARTMS. Mr. Foster remarked, “Len’s deep knowledge of radiopharmaceuticals and molecular imaging and 35 years experience with GE Healthcare will be a valuable asset to the ARTMS Board. I look forward to him joining us on the Board.”

About ARTMS
Based in Vancouver, British Columbia, ARTMS Products Inc. is a leader in the development of novel technologies and products which enable the production of the world’s most-used diagnostic imaging isotope, technetium‐99m (Tc‐99m), using local, hospital-based medical cyclotrons. In addition to Tc-99m, ARTMS has developed advanced solutions for the supply of gallium-68 (Ga-68), zirconium-89 (Zr-89) and copper-64 (Cu-64). ARTMS holds the exclusive global commercialization rights to award-winning and proprietary Canadian inventions which address these challenges, and which offer the prospect of revolutionizing the nuclear medicine industry.

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ARTMS Products Received $1.5 Million of Funding from the Federal Government

VANCOUVER, British Columbia–August 14, 2019– ARTMS Products Inc., a global leader in the development and commercialization of novel technologies and products that enable cyclotron production of the world’s most needed medical radioisotopes, is pleased to announce they have received $1.5 million funding from Western Economic Diversification Canada as part of its Business Scale-up and Productivity program. The federal program is designed to support businesses at various stages of development, including high-growth firms, such as ARTMS, wanting to accelerate their growth, scale-up productivity and be more competitive in both domestic and global markets.

The official announcement was made on August 9, 2019, by the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and the Minister responsible for Western Economic Diversification Canada, during an event in North Vancouver to announce funding to support 17 innovative companies in British Columbia with high growth potential.

“Across Canada, innovative companies like ARTMS are developing solutions to today’s biggest challenges, and creating the jobs of the future,” said the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for Western Economic Diversification Canada. “We commend ARTMS for its work in finding new ways to produce medical isotopes used in medical imaging procedures. By supporting dynamic companies in promising sectors across British Columbia, our government is helping turn today’s challenges into opportunities, and create the kinds of middle class jobs that will secure a bright future for our children.”

“We thank Western Economic Diversification Canada for the confidence they have shown in our products and in our team” said Dr. Kaley Wilson, CEO of ARTMS Products. “The funding will help us increase revenue growth and create employment opportunities by allowing us to advance our existing programs, move new products into clinical development, and design and build the second generation QUANTM Irradiation System™.”

ARTMS foundational work is in the world’s most common radioisotope, technetium-99m, which is used in more than 80 percent of all nuclear medicine imaging procedures in cardiology, oncology, and neurology. Sourcing technetium-99m relies on an existing supply chain supported by many aging nuclear reactors. ARTMS is driving a paradigm shift from the current supply chain through its award-winning flagship product, the QUANTM Irradiation SystemTM (QISTM). QIS™ is a hardware and consumable system that provides for cost-effective, decentralized, and local production of important medical isotopes, including technetium-99m. ARTMS is also well into advanced commercialization of cyclotron produced gallium-68, Ga-68, a much sought after and valuable isotope for medical imaging in prostate and neuroendocrine tumours. ARTMS platform technology produces no long-lived radioactive waste and for Tc-99m, advances efforts to eliminate the use of weapons-grade highly enriched uranium in radioisotope production around the world.

The ARTMS QUANTM Irradiation System™ is currently available for most OEM cyclotron systems and has been installed and is operating in a number of countries.

“Having proved concept and completed clinical trials with Tc-99m, ARTMS is well on its way to providing ground-breaking solutions for the local production of other important isotopes, like Ga-68”, remarked founder and Chief Technology Officer, Dr. Paul Schaffer.

The technology was developed in collaboration with TRIUMF, Canada’s particle accelerator centre, and scientists at three health research institutes across Canada: BC Cancer, the Centre for Probe Development and Commercialization, and Lawson Health Research. Early stage research funding was provided by the Government of Canada through NSERC and the Isotope Technology Acceleration Program.

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