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TerThera reached GMP status for their Terbium-161 product, improving clinical access by meeting the highest quality standards.
TerThera reached GMP status for their Terbium-161 product, improving clinical access by meeting the highest quality standards.

Yahoo

time4 days ago

  • Business
  • Yahoo

TerThera reached GMP status for their Terbium-161 product, improving clinical access by meeting the highest quality standards.

GMP TERBIUM-161 PRODUCT LAUNCHED BY TERTHERA BREDA, Netherlands, June 5, 2025 /PRNewswire/ -- TerThera B.V. has officially launched the world's first GMP-compliant Terbium-161 NCA, setting a new benchmark in the commercial scale production of this promising radionuclide. Now, with the successful implementation of European Good Manufacturing Practices (GMP), TerThera's Terbium-161 meets the highest quality and safety standards required for clinical trials and patient care across Europe and beyond. This lowers regulatory barriers and accelerates the path to new therapies providing hospitals, clinicians, and researchers immediate access to this next-generation therapeutic radionuclide Terbium-161. A New Era in Cancer Treatment Terbium-161 NCA is a no-carrier-added, neutron-activated radionuclide uniquely suited for Radio Ligand Therapy (RLT). With an abundant emission of Auger electrons and high Linear Energy Transfer (LET), combined with similar chemical characteristics to well-known radiolanthanides, Tb-161 brings a high potential to decimate both primary tumors and (micro) metastases. When paired with proven targeting vectors like PSMA, SST, and FAPI analogues, Tb-161 demonstrates a bioequivalence while significantly increasing absorbed doses in all lesions, offering novel treatment options and strategies in cancer healthcare, improving the overall disease control and may even overcome radio-resistant disease. Global Vision, Local Innovation "This milestone is more than a regulatory achievement—it's a leap forward in our mission to bring Terbium-161 to patients worldwide," said Philippe van Overeem, CEO of TerThera. "GMP Terbium-161 is now a clinical reality, and this is just the beginning. We are actively constructing a large-scale production facility to meet the growing global demand and expand access to this promising radionuclide for optimized cancer treatments." With this launch, TerThera reaffirms its commitment to transforming the landscape of radiopharmaceuticals and leading the charge in precision oncology. About TerThera BV TerThera is a radionuclide production-focused company based in The Netherlands. The founders and staff of TerThera have decades of experience in the nuclear medicine industry and are highly dedicated to bringing the innovative radionuclide Terbium-161 (Tb-161) to the clinic. TerThera is building a global platform including GMP production facilities in Europe, USA and Asia to meet the growing demand for radionuclides in RLT. support@ View original content: SOURCE TerThera Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

ASP Isotopes and Isotopia Announce Supply Agreement for Gadolinium-160 to Accelerate Terbium-161 Production for Advanced Cancer Therapies
ASP Isotopes and Isotopia Announce Supply Agreement for Gadolinium-160 to Accelerate Terbium-161 Production for Advanced Cancer Therapies

Cision Canada

time7 days ago

  • Business
  • Cision Canada

ASP Isotopes and Isotopia Announce Supply Agreement for Gadolinium-160 to Accelerate Terbium-161 Production for Advanced Cancer Therapies

PETACH TIKVA, Israel, June 2, 2025 /CNW/ -- ASP Isotopes Inc. (NASDAQ: ASPI) and Isotopia Molecular Imaging Ltd. have entered into a strategic agreement to secure the supply of Gadolinium-160 (Gd-160), a critical precursor isotope for producing Terbium-161 (Tb-161), an emerging medical isotope with significant potential in targeted radiotherapeutics. This partnership addresses longstanding supply challenges for Gd-160, enabling Isotopia to advance Tb-161-based therapies for prostate cancer, neuroendocrine tumors, and other malignancies. Under the agreement, ASP Isotopes will leverage its proprietary Quantum Enrichment technology to provide Isotopia with enriched Gd-160, a stable isotope essential for manufacturing Tb-161. The collaboration combines ASP Isotopes' expertise in large-scale isotope enrichment—previously demonstrated through its production of Ytterbium-176 (Yb-176)—with Isotopia's proven capabilities in commercial-scale medical isotope production. Isotopia has consistently manufactured Lutetium-177 (Lu-177) and maintained weekly Tb-161 production for its clinical trials over the past two years. Paul Mann, CEO of ASP Isotopes, emphasized the agreement's significance: "By supplying Gd-160, we are eliminating a major bottleneck in the development of Tb-161 therapies. Our investment in enrichment technology positions us to support the radiopharmaceutical industry's growing demand for stable isotopes. This partnership accelerates the path to clinical adoption of Tb-161, which could redefine cancer treatment paradigms." Dr. Eli Shalom, CEO of Isotopia, highlighted Tb-161's therapeutic advantages: "Tb-161's dual mechanism of action, including Auger electron emissions, enables precise targeting of micro-metastases while minimizing damage to healthy tissues. This partnership ensures a reliable Gd-160 supply chain, allowing us to scale production and advance our Tb-161-labeled drug candidates toward commercialization. We produce in our site in Israel and shortly the production will start in our second site in Indianapolis in the US." Tb-161's Auger electrons induce double-strand DNA breaks in cancer cells, offering potential advantages over Lu-177 and alpha-emitting isotopes. This precision aligns with the oncology field's shift toward targeted radiotherapeutics, which improve efficacy and reduce side effects. The agreement comes as global interest in radiopharmaceuticals surges, driven by their ability to deliver localized radiation therapy via tumor-seeking molecules. About ASP Isotopes Inc. ASP Isotopes Inc. specializes in advanced isotope separation technologies, including its proprietary Aerodynamic Separation Process and Quantum Enrichment, which produce stable isotopes without radioactive waste. The company's initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries. The Company has isotope enrichment facilities in Pretoria, South Africa. For more information, please visit About Isotopia Molecular Imaging Ltd. Isotopia is a global leader in medical isotope production, with facilities in Israel, Europe, and the U.S. Its integrated platform includes cyclotrons, Lu-177 and Tb-161 production sites, and sterile manufacturing capabilities. The company collaborates with researchers and clinicians to develop novel radiopharmaceuticals for diagnostics and targeted therapy. This partnership positions both companies at the forefront of the radiopharmaceutical revolution, with the potential to expand treatment options for cancer patients worldwide.

ASP Isotopes and Isotopia Announce Supply Agreement for Gadolinium-160 to Accelerate Terbium-161 Production for Advanced Cancer Therapies
ASP Isotopes and Isotopia Announce Supply Agreement for Gadolinium-160 to Accelerate Terbium-161 Production for Advanced Cancer Therapies

Yahoo

time02-06-2025

  • Business
  • Yahoo

ASP Isotopes and Isotopia Announce Supply Agreement for Gadolinium-160 to Accelerate Terbium-161 Production for Advanced Cancer Therapies

PETACH TIKVA, Israel, June 2, 2025 /PRNewswire/ -- ASP Isotopes Inc. (NASDAQ: ASPI) and Isotopia Molecular Imaging Ltd. have entered into a strategic agreement to secure the supply of Gadolinium-160 (Gd-160), a critical precursor isotope for producing Terbium-161 (Tb-161), an emerging medical isotope with significant potential in targeted radiotherapeutics. This partnership addresses longstanding supply challenges for Gd-160, enabling Isotopia to advance Tb-161-based therapies for prostate cancer, neuroendocrine tumors, and other malignancies. Under the agreement, ASP Isotopes will leverage its proprietary Quantum Enrichment technology to provide Isotopia with enriched Gd-160, a stable isotope essential for manufacturing Tb-161. The collaboration combines ASP Isotopes' expertise in large-scale isotope enrichment—previously demonstrated through its production of Ytterbium-176 (Yb-176)—with Isotopia's proven capabilities in commercial-scale medical isotope production. Isotopia has consistently manufactured Lutetium-177 (Lu-177) and maintained weekly Tb-161 production for its clinical trials over the past two years. Paul Mann, CEO of ASP Isotopes, emphasized the agreement's significance: "By supplying Gd-160, we are eliminating a major bottleneck in the development of Tb-161 therapies. Our investment in enrichment technology positions us to support the radiopharmaceutical industry's growing demand for stable isotopes. This partnership accelerates the path to clinical adoption of Tb-161, which could redefine cancer treatment paradigms." Dr. Eli Shalom, CEO of Isotopia, highlighted Tb-161's therapeutic advantages: "Tb-161's dual mechanism of action, including Auger electron emissions, enables precise targeting of micro-metastases while minimizing damage to healthy tissues. This partnership ensures a reliable Gd-160 supply chain, allowing us to scale production and advance our Tb-161-labeled drug candidates toward commercialization. We produce in our site in Israel and shortly the production will start in our second site in Indianapolis in the US." Tb-161's Auger electrons induce double-strand DNA breaks in cancer cells, offering potential advantages over Lu-177 and alpha-emitting isotopes. This precision aligns with the oncology field's shift toward targeted radiotherapeutics, which improve efficacy and reduce side effects. The agreement comes as global interest in radiopharmaceuticals surges, driven by their ability to deliver localized radiation therapy via tumor-seeking molecules. About ASP Isotopes Inc. ASP Isotopes Inc. specializes in advanced isotope separation technologies, including its proprietary Aerodynamic Separation Process and Quantum Enrichment, which produce stable isotopes without radioactive waste. The company's initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries. The Company has isotope enrichment facilities in Pretoria, South Africa. For more information, please visit About Isotopia Molecular Imaging Ltd. Isotopia is a global leader in medical isotope production, with facilities in Israel, Europe, and the U.S. Its integrated platform includes cyclotrons, Lu-177 and Tb-161 production sites, and sterile manufacturing capabilities. The company collaborates with researchers and clinicians to develop novel radiopharmaceuticals for diagnostics and targeted therapy. This partnership positions both companies at the forefront of the radiopharmaceutical revolution, with the potential to expand treatment options for cancer patients worldwide. Contact: eshalom@ SOURCE Isotopia Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Kinectrics and Isotopia Enter Agreement for Supply of Gadolinium-160 (Gd-160) to Support Production of Terbium-161 (Tb-161) for Advanced Radiotherapeutics
Kinectrics and Isotopia Enter Agreement for Supply of Gadolinium-160 (Gd-160) to Support Production of Terbium-161 (Tb-161) for Advanced Radiotherapeutics

Yahoo

time30-01-2025

  • Business
  • Yahoo

Kinectrics and Isotopia Enter Agreement for Supply of Gadolinium-160 (Gd-160) to Support Production of Terbium-161 (Tb-161) for Advanced Radiotherapeutics

TORONTO, Jan. 30, 2025 /PRNewswire/ -- Kinectrics and Isotopia have announced a groundbreaking agreement under which Kinectrics will provide Isotopia with a reliable supply of Gadolinium-160 (Gd-160). This critical isotope will enable Isotopia's production of Terbium-161 (Tb-161), a medical isotope showing great promise and superiority for use in radiotherapeutics, including therapies targeting prostate and neuroendocrine tumors. This partnership represents a significant step forward in addressing the limited access to Gd-160, a barrier that has long restricted the advancement of Tb-161-based treatments into clinical trials. Kinectrics' brings proven expertise in isotope enrichment for Ytterbium-176 (Yb-176) and now is leveraging that technology to bring forward Gd-160. Isotopia has consistently produced high-quality, commercial-scale quantities of Lu-177 and for the last two years produced Tb-161 on a weekly basis for its own clinical trial. With access to Gd-160 secured, this agreement is expected to accelerate the development of Tb-161-based radiotherapeutics, moving them one step closer to commercial availability. David Harris, President and CEO of Kinectrics, expressed his excitement about the new agreement: "We are extremely pleased to partner with Isotopia in providing the critical isotope Gadolinium-160 to support their production of Terbium-161. After years of research and development as well as significant investment, Kinectrics is proud to be producing highly enriched stable isotopes for the radiopharmaceutical industry. This agreement removes a key bottleneck to advancing Tb-161-based therapies, and we look forward to contributing to the progression of these treatments into late-stage clinical trials." Dr. Eli Shalom, CEO of Isotopia, had this to say about this long-term partnership: "Terbium-161 has long been considered a promising radioactive isotope for targeted cancer therapy, as it has two different mechanisms for cancer cell destruction. Tb-161 offers a potential advantage over Lu-177 due to its emission of Auger electrons, which are highly effective in targeting micro-metastases by causing double-strand DNA breaks. This mechanism may deliver precise therapeutic benefits while reducing side effects compared to alpha-emitting isotopes. We are excited about this partnership with Kinectrics, as it will enable Isotopia to deliver on its promise to bring Tb-161 to the marketplace and allow us to advance our own Tb-161-labeled drug products. Radiotherapeutics are gaining increasing attention in the medical community due to their ability to deliver highly targeted treatment to cancer cells while minimizing collateral damage to surrounding healthy tissue. About KinectricsKinectrics is a category leader in providing lifecycle management services for the electricity industry. Trusted by clients worldwide, our expertise in engineering, testing, inspection, and certification is backed by our independent laboratory and testing facilities, a diverse fleet of field inspection equipment and an award-winning team of over 1,300 engineers and technical experts. From initial design and type testing to operational deployment and maintenance services, Kinectrics collaborates closely with customers to ensure that utility assets perform safely, reliably, and efficiently throughout their entire lifecycle. Kinectrics is a founding member of the Nuclear Innovation Institute (NII) and the Canadian Nuclear Isotope Council (CNIC). About IsotopiaIsotopia Molecular Imaging Ltd. is a leader in the supply of Lu-177 and Tb-161, with a global manufacturing footprint in Israel, Europe, and the United States. Its development team includes nuclear pharmacists, radiochemists, nuclear engineers, and physicists. Combined with its nuclear pharmacy, cyclotron facility, 177Lu / 161 Tb production sites, and sterile manufacturing plant, Isotopia provides a well-established platform for manufacturing and industry collaborations. Isotopia's collaborations with the scientific and medical communities allow it to further develop and experiment with new markers for imaging applications and molecular therapy. Contact:eshalom@ SOURCE Isotopia; Kinectrics Sign in to access your portfolio

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