A Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Men With Biochemical Recurrence of Prostate Cancer

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.

Start Date01 Apr 2024

Sponsor / Collaborator

Curium US Holdings LLC

NCT06235151 / RecruitingPhase 3

Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

Start Date01 Apr 2024

Sponsor / Collaborator

Curium US Holdings LLC

NCT05653856 / CompletedPhase 2

A Multi-Center, Open-Label, Randomized Phase 2 Study of Copper Cu 64 PSMA I&T Injection in Patients With Histologically Proven Metastatic Prostate Cancer

This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.

Start Date05 Dec 2022

Sponsor / Collaborator

Curium US Holdings LLC

100 Clinical Results associated with Copper Cu64 PSMA I&T

100 Translational Medicine associated with Copper Cu64 PSMA I&T

100 Patents (Medical) associated with Copper Cu64 PSMA I&T

Literatures (Medical) associated with Copper Cu64 PSMA I&T

01 Jan 2024·Nuclear Medicine and Biology

64Cu production via the 68Zn(p,nα)64Cu nuclear reaction: An untapped, cost-effective and high energy production route

Article

Author: Wuest, Melinda ; Wilson, John ; Nelson, Bryce J B ; Leier, Samantha ; Doupe, Jonathan ; Wuest, Frank ; Andersson, Jan D

INTRODUCTIONCopper-64 (⁶⁴Cu, t_1/2 = 12.7 h) is a positron emitter well suited for theranostic applications with beta-emitting ⁶⁷Cu for targeted molecular imaging and radionuclide therapy. The present work aims to evaluate the radionuclidic purity and radiochemistry of ⁶⁴Cu produced via the ⁶⁸Zn(p,nα)⁶⁴Cu nuclear reaction. Macrocyclic chelators DOTA, NOTA, TETA, and prostate-specific membrane antigen ligand PSMA I&T were radiolabeled with purified ⁶⁴Cu and tested for in vitro stability. [⁶⁴Cu]Cu-PSMA I&T was used to demonstrate in vivo PET imaging using ⁶⁴Cu synthesized via the ⁶⁸Zn(p,nα)⁶⁴Cu production route and its suitability as a theranostic imaging partner alongside ⁶⁷Cu therapy.METHODS⁶⁴Cu was produced on a 24 MeV TR-24 cyclotron at a beam energy of 23.5 MeV and currents up to 70 μA using 200 mg ⁶⁸Zn encapsulated within an aluminum‑indium-graphite sealed solid target assembly. ⁶⁴Cu semi-automated purification was performed using a NEPTIS Mosaic-LC synthesis unit employing CU, TBP, and TK201 (TrisKem) resins. Radionuclidic purity was measured by HPGe gamma spectroscopy, while ICP-OES assessed elemental purity. Radiolabeling was performed with NOTA at room temperature and DOTA, TETA, and PSMA I&T at 95 °C. ⁶⁴Cu incorporation was studied by radio-TLC. ⁶⁴Cu in vitro stability of [⁶⁴Cu]Cu-NOTA, [⁶⁴Cu]Cu-DOTA, [⁶⁴Cu]Cu-TETA, and [⁶⁴Cu]Cu-PSMA I&T was assessed at 37 °C from 0 to 72 h in human blood serum. Preclinical PET imaging was performed at 1, 24, and 48 h post-injection with [⁶⁴Cu]Cu-PSMA I&T in LNCaP tumor-bearing mice and compared with [⁶⁸Ga]Ga-PSMA I&T.RESULTSMaximum purified activity of 4.9 GBq [⁶⁴Cu]CuCl₂ was obtained in 5 mL of pH 2-3 solution, with 2.9 GBq ⁶⁴Cu concentrated in 0.5 mL. HPGe gamma spectroscopy of purified ⁶⁴Cu detected <0.3 % co-produced ⁶⁷Cu at EOB with no other radionuclidic impurities. ICP-OES elemental analysis determined <1 ppm Al, Zn, In, Fe, and Cu in the [⁶⁴Cu]CuCl₂ product. NOTA, DOTA, TETA, and PSMA I&T were radiolabeled with ⁶⁴Cu, resulting in maximum molar activities of 164 ± 6 GBq/μmol, 155 ± 31 GBq/μmol, 266 ± 34 GBq/μmol, and 117 ± 2 GBq/μmol, respectively. PET imaging in PSMA-expressing LNCaP xenografts resulted in high tumor uptake (SUV_mean = 1.65 ± 0.1) using [⁶⁴Cu]Cu-PSMA I&T, while [⁶⁸Ga]Ga-PSMA I&T yielded an SUV_mean of 0.76 ± 0.14 after 60 min post-injection.CONCLUSIONS⁶⁴Cu was purified in a small volume amenable for radiolabeling, with yields suitable for preclinical and clinical application. The ⁶⁴Cu production and purification process and the favourable PET imaging properties confirm the ⁶⁸Zn(p,nα)⁶⁴Cu nuclear reaction as a viable ⁶⁴Cu production route for facilities with access to a higher energy proton cyclotron, compared to using expensive ⁶⁴Ni target material and the ⁶⁴Ni(p,n)⁶⁴Cu nuclear reaction.ADVANCES IN KNOWLEDGE AND IMPLICATIONS FOR PATIENT CAREOur ⁶⁴Cu production technique provides an alternative production route with the potential to improve ⁶⁴Cu availability for preclinical and clinical studies alongside ⁶⁷Cu therapy.

01 Aug 2022·Cancer Biotherapy and RadiopharmaceuticalsQ4 · MEDICINE

The Feasibility of ⁶⁴Cu-PSMA I&T PET for Prostate Cancer

Q4 · MEDICINE

Article

Author: Choi, Chang Woon ; Lim, Ilhan ; Lim, Sang Moo ; Kim, Kwang Il ; Lee, Chul-Hee ; Woo, Sang-Keun ; Song, Kanghyon ; Lee, Kyo Chul

Background: The goal of this research was to investigate the feasibility of ⁶⁴Cu labeling in prostate-specific membrane antigen imaging and therapy (PSMA I&T) for PSMA positron emission tomography (PET) imaging and biodistribution evaluation. Materials and Methods: PSMA I&T was labeled with ⁶⁴Cu, and stability in human and mouse sera was evaluated. Prostate cancer cell lines were used for specific uptake assays (22RV1 for PSMA-positive, PC-3 for -negative). Both PC-3 and 22RV1 cells were transplanted into the left and right thighs in a mouse for PET/computed tomography (CT) imaging. Biodistribution was performed using 22RV1 tumor models. Results: Labeling yield (decay corrected) of ⁶⁴Cu-PSMA I&T was more than 95% compared to the free ⁶⁴Cu peak. The serum stability of ⁶⁴Cu-PSMA I&T was maintained at more than 90% until 60 h. Regarding the specific binding of ⁶⁴Cu-PSMA I&T was 7.5-fold higher to 22RV1 cells than PC-3 cells (p < 0.001). On PET/CT imaging, more specific ⁶⁴Cu-PSMA I&T uptake was observed to 22RV1 tumors than to PC-3 tumors. In the PSMA blocking study using 2-phosphonomethoxypropyl adenine (2-PMPA), the ⁶⁴Cu-PSMA I&T signal significantly decreased in the 22RV1 tumor region. In the biodistribution study, the kidney uptake was the highest among all organs at 2 h (52.6 ± 20.8%ID/g) but sharply decreased at 24 and 48 h. Also, the liver showed similar uptake over time (range, 10-12%ID/g). On the contrary, ⁶⁴Cu-PSMA I&T uptake of the tumors increased with time and peaked at 48 h (5.6 ± 0.1%ID/g). Conclusions: PSMA I&T labeled with ⁶⁴Cu showed the feasibility of the PSMA specific PET imaging through in vitro and in vivo studies. Furthermore, ⁶⁴Cu-PSMA I&T might be considered as the candidate of future clinical trial.

01 Dec 2020·Cancer ImagingQ2 · MEDICINE

PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review

Q2 · MEDICINE

ReviewOA

Author: Zacho, Helle D ; Petersen, Lars J

AbstractBackgroundPSMA PET is a promising method for primary lymph node staging in prostate cancer. However, recent systematic reviews have identified only a limited number of studies with histopathology as a reference test.MethodsA systematic search was performed in PubMed and the Cochrane Library. An expedited systematic review was performed where we identified diagnostic studies in prostate cancer where a preoperative PSMA PET for primary lymph node staging was compared to histopathology. The trials must have diagnostic data on a patient level.ResultsEighteen eligible clinical trials included 969 patients. The median patient number per study was 32 (range 10 to 208). Five trials were prospective, and nine trials had a consecutive enrolment of patients. Sixteen studies used Ga-68-PSMA-11; there was one study with Cu-64-PSMA and one study with F-18-DCDFPyL. Twelve studies used PET/CT, four trials used PET/MR. Most trials included patients with intermediate and high-risk. Diagnostic accuracy varied notably among the studies; sensitivity ranged from 23 to 100%, specificity 67–100%, positive predictive value 20–100%, and negative predictive value 41–100%. Weighted sensitivity was 59%, weighted specificity was 93%. Four studies compared PSMA PET with anatomical imaging (CT or MRI); in all cases, sensitivity and specificity were superior with PSMA PET. Three studies compared PSMA PET with multi-parametric or diffusion-weighted MRI with mixed results.ConclusionsPSMA PET showed promising diagnostic accuracy for primary lymph node staging with pathology as reference. Recommendation for PSMA PET for high-risk patients in clinical guidelines should be supported by confirmatory, prospective trials with patient-relevant outcomes.

News (Medical) associated with Copper Cu64 PSMA I&T

03 Oct 2024

·www.globenewswire.com

Curium Announces Strategic Partnership with PeptiDream for Prostate Cancer Theranostics in Japan

Collaboration to include the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T Builds on long-standing relationship between the two companies In Japan around 90,000 new cases of prostate cancer are diagnosed each year Oct. 01, 2024 -- Curium, a world leader in nuclear medicine, announced today that it has entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T. The two agents 177Lu-PSMA-I&T and 64Cu-PSMA-I&T target prostate specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. Both target tumors with high levels of PSMA expression and thus potentially forming a theranostic (therapeutic & diagnostic) pair. Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology. Patrick C. Reid, President & CEO of PeptiDream commented: “Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these powerful targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their highly promising prostate cancer targeting radiopharmaceuticals to patients in Japan.” Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: “We are excited to partner with Curium in the development of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T, highly promising products for both the diagnosis and treatment of PSMA-expressing prostate cancer. We look forward to working with Curium to deliver these much-needed agents to prostate cancer patients in Japan as quickly as possible.” Chaitanya Tatineni, Curium’s CEO International Markets commented: “As a global innovator in the field of radiopharmaceuticals with a promising late-stage oncology pipeline, Curium is delighted to partner with PDRadiopharma which has more than four decades of experience in Japan. Curium and PDRadiopharma plan to leverage their complementary strengths to accelerate the development of innovative products for the benefit of prostate cancer patients in Japan.” Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases, with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies. 177Lu-PSMA-I&T, a PSMA inhibitor conjugated with the radioisotope Lutetium 177, is currently being tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). ECLIPSE is a multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T versus hormone therapy in patients with metastatic castration-resistant prostate cancer. The ECLIPSE trial enrolled over 400 patients, across 51 trial sites in the United States and Europe. 64Cu-PSMA-I&T PET is currently being investigated in 2 multicenter Phase 3 trials; SOLAR RECUR testing the diagnostic performance in men with biochemical recurrence of prostate cancer (ClinicalTrials.gov identifier NCT06235099) and SOLAR STAGE testing the diagnostic performance in men with newly diagnosed unfavorable intermediate- to high-risk prostate cancer (ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer. PSMA-targeted PET/CT imaging is increasingly emerging as a highly sensitive method for detection of locally recurrent or metastatic lesions in the context of biochemical recurrence and for localization of primary prostate cancer. Curium and PDRadiopharma have a long-standing relationship in the radiopharmaceutical field. PeptiDream Inc. (Tokyo Stock Exchange Prime Market 4587) is leading the translation of macrocyclic peptides into a whole new class of innovative medicines to address unmet medical needs and improve the quality of life of patients worldwide. In its radiopharmaceutical business, through its wholly-owned subsidiary PDRadiopharma, PeptiDream markets and sells a number of approved radiopharmaceuticals and radiodiagnostics in Japan, as well as leveraging its proprietary Peptide Discovery Platform System (PDPS) technology to discover and develop a deep pipeline of innovative targeted radiotherapeutics and radiodiagnostics, spanning both wholly-owned internal programs and globally partnered programs. In its non-radiopharmaceutical business, PeptiDream is similarly leveraging PDPS to discover and develop a broad and diverse pipeline of investigational peptide therapeutics, peptide drug conjugates (PDC) and multi-functional peptide conjugates (MPC) across an extensive global network of discovery and development partners. PeptiDream is headquartered in Kawasaki, Japan. For more information about our company, science and pipeline, please visit www.peptidream.com/en PDRadiopharma, a wholly-owned subsidiary of PeptiDream since 2022, has been providing high-quality radiopharmaceuticals through the research and development, manufacturing, regulatory and sales as a forerunner in the field in radiopharmaceuticals, since it started its business in 1968. PDRadiopharma currently markets 21 radiodiagnostic products (spanning both SPECT and PET products) and 8 radiotherapeutic products (3 product categories) in Japan. Additionally, PDRadiopharma and PeptiDream are developing a broad pipeline of radiotherapeutics and radiodiagnostics for both the Japan and global markets. For more information about PDRadiopharma, please visit www.pdradiopharma.com/en Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultLicense out/in

23 May 2023

·www.globenewswire.com

Curium Announces Last Patient Enrolled in Their Phase 1/2 SOLAR Clinical Trial Imaging Men with Histologically-Proven Metastatic Prostate Cancer Using Copper Cu 64 PSMA I&T.

PARIS, May 23, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that it has completed enrollment in its USA-led SOLAR Phase 1/2 study evaluating the safety, biodistribution, and image quality of Copper Cu64 PSMA I&T injection to detect metastatic prostate cancer in PET imaging. Michael Patterson, CEO – North America at Curium commented, “We are pleased to complete the Phase 1/2 SOLAR study enrollment ahead of schedule. We are excited to use Curium’s centralized Copper-64 production capabilities and our industry leading distribution network in upcoming Phase 3 trials. As we work globally to redefine the experience of cancer through our trusted legacy in nuclear medicine, we remain focused on driving innovation to improve the lives of more than 14 million patients each year.” Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, “Completing the enrollment of patients for the SOLAR study is not only an important milestone for the study itself, but also a testament to the hard work and dedication of our investigators. We are very pleased with the clinical development progress of Cu-64-PSMA-I&T. After the completion of our analysis, we look forward to collaborating with our future investigators to start our Phase 3 program looking into the use of Cu-64-PSMA-I&T in patients with prostate cancer for initial staging and also for biochemical recurrence.” Prostate cancer is the most common cancer and the second leading cause of cancer death among men in the United States. There will be an estimated 288,000 new cases of prostate cancer in 2023. For more information about the SOLAR trial: https://www.curiumpharma.com/resources/current-clinical-trials/solar-clinical-trial/ To locate a clinical trial site or contact Curium’s SOLAR clinical trial team: solar@curiumpharma.com About Curium Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information: Ross BethellVP, Head of Global Communicationscommunications@curiumpharma.com

Phase 3

100 Deals associated with Copper Cu64 PSMA I&T

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 3	US	Curium Pharma UK Ltd.	23 Apr 2024
Adenocarcinoma of prostate	Phase 3	US	Curium US Holdings LLC	01 Apr 2024
Recurrent Prostate Carcinoma	Phase 3	US	Curium US Holdings LLC	01 Apr 2024
Metastasis from malignant tumor of prostate	Phase 2	US	Curium US Holdings LLC	05 Dec 2022
Metastatic Prostate Carcinoma	Phase 2	US	Curium US Holdings LLC	05 Dec 2022

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