02 Isotope-related News

Department of Energy to Provide $2 Million for Studies to Accelerate the Evaluation of Novel, Medically Relevant Isotopes for Use in Pre-clinical and Clinical Medical Trials

The U.S. Department of Energy (DOE) announced up to $2 million in new funding to support translational research and development (R&D) of novel, medically relevant isotopes to accelerate evaluation for usage in pre-clinical and clinical trials. The new funds will be provided as part of a key federal program that produces critical radioisotopes otherwise unavailable or in short supply for U.S. science, medicine,

national security, and industry, known as the DOE Isotope Program.

To read more please visit:

https://www.energy.gov/science/articles/department-energy-provide-2-millionstudies-accelerate-evaluation-novel-medically Source: U.S. Department of Energy, Office of Science

NorthStar Medical Radioisotopes Enters U.S. Supply Agreement for Commercial Supply of Therapeutic Radioisotope Copper-67 (Cu-67) Exclusively to Clarity Pharmaceuticals for its Targeted Copper Theranostics Programs

Cu-67 is a beta-emitting radioisotope with clinical applications as a radiopharmaceutical to directly target and deliver therapeutic doses of radiation to destroy cancer cells in

patients .

NorthStar Medical Radioisotopes, LLC, a global company engaged in the development, production and commercialization of radiopharmaceuticals used for therapeutic

applications and medical imaging, and Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, today

announced the signing of a Master Supply Agreement for the therapeutic radioisotope copper-67 (Cu-67). Under the agreement, NorthStar will supply Cu-67 exclusively to

Clarity Pharmaceuticals as an active pharmaceutical ingredient used to support Clarity’s Targeted Copper Theranostics (TCT) programs.

To read more please visit: https://www.claritypharmaceuticals.com/news/northstar/ Source: Clarity Pharmaceuticals

Northern Indiana business making isotopes to create ripple effect

AZIotopes, a new company in Indiana is hitting the ground running in using subatomic particles to treat people with various medical conditions, and it could have a ripple effect

in the employing of more Hoosiers.

AZIsotopes is a life sciences company that makes isotopes that can be used by hospitals to treat people with cancer and can be used in diagnostic imaging.

The CEO Greg Brooksby credited congresswoman Jackie Walorski for enabling the experts from Europe to travel to the U.S. to help them get their massive cyclotron up

and running.

He recently announced on Inside Indiana Business that their equipment is nearly ready

to start mass producing isotopes, while pointing out that demand is high.

To read more please visit:

https://www.953mnc.com/2021/05/30/northern-indiana-business-making-isotopesto-create-ripple-effect/

Source: 93.5MNC

Fusion Pharmaceuticals Enters Into Agreement To Build Radiopharmaceutical Manufacturing Facility

Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, recently announced it has entered into a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be built by McMaster and equipped and validated by Fusion, will be designed to support the manufacturing of the company's growing pipeline of targeted alpha therapies (TATs). Fusion expects the manufacturing facility to be operational by early 2024.

To read more please visit:

https://ir.fusionpharma.com/2021-06-02-Fusion-Pharmaceuticals-Enters-intoAgreement-to-Build-Radiopharmaceutical-Manufacturing-Facility Source: Fusion Pharmaceuticals

Best Cyclotron Systems, a TeamBest Global Company, Announces Upgrade of their Best 35–70 MeV Proton Cyclotron to 1000 µA

Best Cyclotron Systems (BCS) was happy to introduce their high energy Best 35–70 MeV Proton Cyclotron (B35–70p) for research, industrial, green-energy and medical

radioisotope production applications. The high energy cyclotron would enable production of radionuclides by (p,xn) reactions both for research as well as routine radioisotope production. TeamBest Global (TBG) will partner with the end-user to create a facility that will satisfy the end user's requirements and provide some of TBG's

radioisotope supply requirements, together with the opportunity for joint research projects. Both solid and gas target systems can be added to the B35–70p System. The B35–70p Cyclotron is supplied with liquid, solid as well as gas target stations that can be operated at high current (up to 1000 µA). The first system of its kind has been installed in INFN, Legnaro, Italy and is currently functional. This has a simple, easy-to-

maintain design with external ion sources.

To read more please visit: https://www.einnews.com/pr_news/543393171/best-cyclotron-systems-a-teambest-globalcompany-announces-upgrade-of-their-best-35-70-mev-proton-cyclotron-to-1000-a

Source: EIN Presswire

Michigan State welcomes the Arrival of World-leading Cyclotron Technology

Michigan State University and global theranostics, health care technology innovator Bold Advanced Medical Future, or BAMF, Health have, recently, announced the delivery of two advanced GE PETtrace 890 cyclotrons at the Doug Meijer Medical Innovation Building. The arrival classifies the facility, which is located at the base of the Medical Mile in the downtown Grand Rapids Innovation Park, as the most modern and advanced dual-cyclotron radio-pharmacy in the world.

The 12,000 square foot radio-pharmacy, when operating at full capacity, will support the growing diagnostic and therapeutic needs of thousands of cancer patients both from West Michigan and around the country. The cyclotrons will complement the world’s most

advanced molecular imaging clinic and the world’s most advanced theranostics clinic.

To read more please visit:

https://msutoday.msu.edu/news/2021/michigan-state-arrival-of-cyclotron-technology Source: Michigan State University

IBA launches Versatile High-Energy Cyclotron IKON

IBA (Ion Beam Applications S.A., EURONEXT), the world's leading provider of solutions for the diagnosis and treatment of cancer, recently launched its new high energy, highcapacity cyclotron. The Cyclone® IKON offers the largest energy spectrum for PET and

SPECT isotopes from 13 MeV to 30 MeV. The Cyclone® IKON was showcased during a virtual live event and the replay can be watched at the site below.

To read more please visit:

https://www.dotmed.com/news/story/55070 Source: HealthCare Business News

SHINE Medical announces Agreement with MURR

SHINE Medical Technologies LLC recently announced that it has entered a multi-year contract with the University of Missouri Research Reactor, for irradiation of ytterbium176, the starting material for the production of ‘no carrier added’ grade lutetium-177 (Lu-177), a therapeutic isotope that has shown great promise for improving patient outcomes for a range of cancers.

Lu-177 is a low-energy beta-particle emitter that works by directly irradiating cancer cells after being delivered to the cancer site by a targeting molecule. Energy from Lu-

177 only travels a short distance once it reaches cancer cells, enabling the isotope to destroy those cells with little damage to surrounding tissue. Lu-177-based therapy has been approved by the U.S. Food and Drug Administration for the treatment of neuroendocrine cancers. It also shows promise for the treatment of other cancers, including metastatic prostate, breast, liver, and brain cancers.

To read more please visit:

https://shinemed.com/shine-medical-announces-agreement-with-murr/ Source: Shine Medical

Lifesaving Nuclear Medicine Applications Deserve Better Recognition and Support at EU level

FORATOM, the Brussels-based trade association for the nuclear energy industry in

Europe, made up of 15 national nuclear associations representing nearly 3,000 firms acts as the voice of the European nuclear industry in energy policy discussions with EU

Institutions and other key stakeholders. A joint position paper was issued on 14th June 2021 by FORATOM and Nuclear Medicine Europe, urging the European Union to promote new research reactor capacity along with innovation in the sector and the design modification of the current fleet, in line with its Europe’s Beating Cancer Plan, to maintain the current level of medical radioisotopes supply.

The position paper highlights that every year, more than 9 million patients in Europe benefit from nuclear medicine in the diagnosis and treatment of illnesses such as cancer and cardiovascular or neurological disorders and explains the technicalities of nuclear medicine, presents the scope of the current nuclear medicine sector in the European

Union as well as highlighting the challenges that have to be overcome both at regulatory and supply chain levels.

To read more please visit: https://www.foratom.org/press-release/lifesaving-nuclear-medicine-applicationsdeserve-better-recognition-and-support-at-eu-level/

Source: FORATOM

Use of Radioactive Materials in Commercial Applications Has Increased by 30 Percent; Government Should Improve Security and Support Development of Alternatives, Says New Report

The National Academies of Sciences, Engineering, and Medicine has published a report mentioning that the use of high-risk radioactive materials in medical, research, and commercial applications has increased by about 30 percent in the U.S. in the last 12 years, and the government should improve security, tracking, and accountability to reduce health and security risks — while also supporting the development of nonradioactive alternatives to replace them. — . The report refers to the publication

entitled ‘Radioactive Sources: Applications and Alternative Technologies’ which mentions that the U.S. Nuclear Regulatory Commission’s (NRC) system for categorizing and regulating these radioactive materials fails to adequately protect society, and should be overhauled to take into account the long-term health impacts and socioeconomic effects of possible misuse or malicious use — such as in a “dirty bomb”

scenario.

Radioactive materials are used commercially in a wide range of applications, such as treating blood before transfusion, sterilizing medical devices, treating cancer, exploring geological formations, and finding oil and gas deposits. The responsibility of securing these materials falls to the universities, hospitals, and commercial facilities that use them. If these materials are mishandled, or if they are used maliciously, they have the

potential to cause billions of dollars of damage. There would be a huge economic impact, large scale cleanups, and loss of access to affected areas — even if only small amounts of the material are involved.

A previous National Academies report on commercial applications of radiological materials published in 2008 called on the government to accelerate the replacement of cesium chloride — a material of greater concern than other radiological sources — because it was widely used, soluble, and dispersible, and therefore could potentially be used in terrorism. The new report published finds some progress has been made since 2008 in replacing cesium irradiators with X-ray technology for blood treatment and research. However, no progress has been made in replacing cesium chloride from applications such as calibration systems used for radiation monitoring equipment.

To read more please visit: https://www.nationalacademies.org/news/2021/06/use-of-radioactive-materials-incommercial-applications-has-increased-by-30-percent-government-should-improvesecurity-and-support-development-of-alternatives-says-new-report Source: The National Academies of Sciences Engineering Medicine

In fight against Wildlife Trafficking, Brazil Police Turn to Nuclear Science

In Brazil, as in many other biodiverse countries around the world, the commercial trade of some species of wildlife is allowed — as long as the animal was bred in captivity and not captured from the wild. But identifying illegally captured wild animals in the possession of authorized breeders has always been a challenge for government agencies in Brazil. In many cases, proof of fraud is only possible through laboratory analysis, but operations to identify wildlife trafficking rarely have access to such

technology.

Stable isotope analysis works on the basis that chemical elements can have different

compositions of the stable isotopes of that element, depending on the source from where it originates.. The ratios of these stable isotopes to one another vary by region. Hence, finding the isotope ratio of a certain element in the food ingested by an animal, say, from its fur can provide valuable information of its origin and is the equivalent to a barcode that can point to where it came from. Brazil is planning to use stable isotope techniques in operations to identify wildlife trafficking.

To read more please visit: https://news.mongabay.com/2021/06/in-fight-against-wildlife-trafficking-brazilpolice-turn-to-nuclear-science/

Source: MONGABAY

Clovis Oncology Announces LuMIERE Clinical Trial Evaluating Novel Peptide-Targeted Radionuclide Therapy FAP-2286 Now Open For Enrollment

Clovis Oncology, Inc. (USA) recently announced that the first clinical site for the Phase 1/2 LuMIERE study of FAP-2286, its novel peptide-targeted radionuclide therapy and

imaging agent targeting fibroblast activation protein (FAP), is now open at the O’Neal Comprehensive Cancer Center at The University of Alabama at Birmingham (UAB).

The O'Neal Comprehensive Cancer Center at UAB is among the leading cancer research institutions of the USA and one of only 51 comprehensive cancer centers designated by the National Cancer Institute.

The Phase 1 portion of the LuMIERE study will evaluate the safety of the FAP-targeting investigational therapeutic agent and identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts

are planned in multiple tumor types.

To read more please visit:

https://ir.clovisoncology.com/investors-and-news/news-releases/press-releasedetails/2021/Clovis-Oncology-Announces-LuMIERE-Clinical-Trial-Evaluating-NovelPeptide-Targeted-Radionuclide-Therapy-FAP-2286-Now-Open-forEnrollment/default.aspx Source: CLOVIS Oncology

NEW CRP: Improving Efficiency of National Livestock Breeding Programs Using Nuclear and Related Genomic Information –Practical Applications in Developing Countries

The IAEA is launching a 5-year Coordinated Research Project (CRP) on applying nuclear and related genomic technologies for enhancing the efficiency of national dairy cattle breeding programs to improve productivity and adaptability of local genetic stock. Three major dairy animal species, namely cattle, buffalo and camel, will be targeted. The CRP will help to develop nuclear and related genomic tools/resources (e.g. cost effective

DNA chips for genotyping, reference population for locally available breeds, radiolabelled biomarker assay for early pregnancy diagnosis, etc.) and establish strategies to incorporate genomic information for the selection and breeding of dairy animals.

The CRP will comprise of 10 Research Contract (RC) holders from developing countries, three Technical Contract (TC) holders and four Research Agreement (RA) holders from laboratories engaged in advanced animal genetics and breeding research. Nuclear

techniques involving isotopes such as Cobalt-60 (radiation hybrid mapping), Carbon-13 and Nitrogen-15 (biomarker discovery) and Iodine-125 (early pregnancy radioimmunoassay) will be utilized to address the objectives.

To read more please visit: https://www.iaea.org/newscenter/news/new-crp-improving-efficiency-of-nationallivestock-breeding-programmes-using-nuclear-and-related-genomic-information-

practical-applications-in-developing-countries-d31030

Source: IAEA

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