A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in Subjects With Somatostatin Receptor Expressing Neuroendocrine Tumors

Multicenter Phase 2 study of 212Pb-DOTAMTATE enrolling adult subjects with positive somatostatin positive neuroendocrine tumors with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history of peptide receptor radionuclide therapy (Previous PRRT)

开始日期2021-12-21

申办/合作机构

Orano Med LLC

[+1]

NCT03466216

/ Terminated临床1期

A Phase 1, Non-Randomized, Open-Label, Dose Escalation, Single-Center Study to Determine the Safety, Bio-distribution, and Preliminary Effectiveness of AlphaMedix™ in Adult Subjects With SSRT(+) NETs.

AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications.
This drug addresses an unmet need in the field of peptide receptor radionuclide therapy (PRRT) for NETs. Substitution of an alpha emitter (²¹²Pb) for the beta emitters currently being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer (LET) and a shorter path length. Higher LET particles should cause more tumor cell death. Shorter path length should result in less collateral damage of the normal tissue and therefore less side effects for subjects receiving the drug.

开始日期2018-02-05

申办/合作机构

Orano Med LLC

100 项与 212Pb-AR-RMX 相关的临床结果

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100 项与 212Pb-AR-RMX 相关的转化医学

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100 项与 212Pb-AR-RMX 相关的专利（医药）

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项与 212Pb-AR-RMX 相关的文献（医药）

2025-12-01·APPLIED RADIATION AND ISOTOPES

Activity standardization and determination of nuclear decay data of 212Pb at LNE-LNHB and first measurements in the SIR at BIPM

Article

作者: Michotte, C ; Coulon, R ; Chambon, L ; Loidl, M ; Amiot, M-N ; Bobin, C ; Carceller, C ; Sabot, B ; Thiam, C ; Pierre, S ; Boyer, B ; Morelli, S ; Courte, S ; Lourenço, V ; Dulieu, C

Lead-212/Bismuth-212 is a promising radiopharmaceutical with high therapeutic potential for Targeted Alpha Therapy. In this paper, the activity standardization of ²¹²Pb in equilibrium with its progeny was addressed by means of several measurement techniques at LNE-LNHB using a radioactive solution of ²¹²Pb-DOTAMTATE supplied by Orano Med (France). The primary standard was established by liquid scintillation counting using the Triple-to-Double Coincidence Ratio (TDCR) method and transferred to the Vinten 671 ionization chamber. The experimental calibration coefficients were compared to Monte Carlo simulations using the Penelope and Geant4 codes. An ampoule filled with a standardized solution of ²¹²Pb was sent to the BIPM for a submission to the International Reference System (SIR). The resulting equivalent activity was compared to the value calculated from the SIRIC software. A new measurement of the half-life of ²¹²Pb using a Centronic IG11 IC is presented. New γ-photon intensities based on γ-spectrometry were also measured. The present study on the metrological traceability of the radiopharmaceutical ²¹²Pb is an important outcome in the framework of the European project EPM AlphaMet (Metrology for Emerging Targeted Alpha Therapies).

2022-09-01·JOURNAL OF NUCLEAR MEDICINE1区 · 医学

Targeted α-Emitter Therapy with ²¹²Pb-DOTAMTATE for the Treatment of Metastatic SSTR-Expressing Neuroendocrine Tumors: First-in-Humans Dose-Escalation Clinical Trial

1区 · 医学

Article

作者: Tworowska, Izabela ; Torgue, Julien ; Delpassand, Ebrahim S ; Núñez, Rodolfo ; Hurt, Jason ; Esfandiari, Rouzbeh ; Shafie, Afshin

Peptide receptor radiotherapy with somatostatin analogs has been successfully used for years as a treatment for somatostatin-overexpressing tumors. Treatment of neuroendocrine tumors (NETs) with the β-particle emitter ¹⁷⁷Lu-DOTATATE is currently considered the standard of care for subjects with gastroenteropancreatic NETs. Despite the success of ¹⁷⁷Lu-DOTATATE, there remains significant room for improvement in terms of both safety and efficacy. Targeted α-emitter therapy with isotopes such as ²¹²Pb has the potential to improve both. Here, we present the preliminary results of the phase 1 first-in-humans dose-escalation trial evaluating ²¹²Pb-DOTAMTATE (a bifunctional metal chelator [DOTAM] and the SSTR-targeting peptide [TATE]) in patients with somatostatin receptor-positive NETs. Methods: Twenty subjects with histologically confirmed NETs, prior positive somatostatin analog scans, and no prior history of ¹⁷⁷Lu/⁹⁰Y/¹¹¹In peptide receptor radiotherapy, with different primary sites of the disease, were enrolled. Treatment began with single ascending doses of ²¹²Pb-DOTAMTATE, with subsequent cohorts receiving an incremental 30% dose increase, which was continued until a tumor response or a dose-limiting toxicity was observed. This was followed by a multiple ascending dose regimen. The recommended phase 2 dose regimen consisted of 4 cycles of 2.50 MBq/kg (67.6 μCi/kg) of ²¹²Pb-DOTAMTATE administered at 8-wk intervals, intravenously. Results: Ten subjects received the highest dose, 2.50 MBq/kg/cycle (67.6 μCi/kg/cycle). Treatment was well tolerated, with the most common treatment-emergent adverse events being nausea, fatigue, and alopecia. No serious treatment-emergent adverse events were related to the study drug, and no subjects required treatment delay or a dose reduction. An objective radiologic response of 80% was observed for the first 10 subjects treated at the recommended phase 2 dose. Conclusion: Targeted α-therapy with ²¹²Pb-DOTAMTATE has been shown to be well tolerated. Preliminary efficacy results are highly promising. If these results are confirmed in a larger, multicenter clinical trial, ²¹²Pb-DOTAMTATE would provide a substantial benefit over currently Food and Drug Administration-approved therapies for patients with metastatic or inoperable SSTR-expressing NETs regardless of the grade and location of the primary tumor.

2019-05-01·MOLECULAR CANCER THERAPEUTICS

Preclinical Investigation of 212Pb-DOTAMTATE for Peptide Receptor Radionuclide Therapy in a Neuroendocrine Tumor Model

Article

作者: Tworowska, Izabela ; Torgue, Julien J. ; Stallons, Tania A. Rozgaja ; Saidi, Amal ; Delpassand, Ebrahim S.

Abstract:

Somatostatin analogues have been examined as a treatment for somatostatin receptor overexpressing tumors for years; specifically, octreotate (TATE) and octreotide (TOC). Several versions of these analogues coupled to beta or gamma nuclides are currently used as imaging agents, as treatments with peptide receptor radionuclide therapy (PRRT) for patients with neuroendocrine tumors or are being explored in preclinical and clinical settings. Our study describes the use of 212Pb-DOTAMTATE, the octreotate analogue, in combination with 212Pb, the parent of an alpha emitter. Preclinical studies demonstrated tumor targeting of 212Pb-DOTAMTATE of >20% ID/g up to 24 hours post drug injection. The addition of kidney protection agents, including l-lysine and l-arginine decreases drug accumulation in the kidneys and the addition of ascorbic acid to the chelation mixture reduces oxidation of the drug product. 212Pb-DOTAMTATE displays a favorable toxicity profile with single-dose injections of 20 μCi showing 100% survival and with nontoxic cumulative doses up to 45 μCi, when fractionated into three smaller doses of 15 μCi. In an initial efficacy study, a single 10 μCi injection of 212Pb-DOTAMTATE extended the mean survival 2.4-fold. Efficacy was enhanced by giving three treatment cycles of 212Pb-DOTAMTATE and reducing the time between injections to two weeks. Efficacy was optimized further by the addition of a chemo-sensitizing agent, 5-fluorouracil, given in combination with three cycles of 10 μCi 212Pb-DOTAMTATE. These conditions led to 79% of the animals being tumor free at the end of the 31-week study suggesting that 212Pb-DOTAMTATE alone or in combination with a chemotherapeutic may have positive clinical implications.

项与 212Pb-AR-RMX 相关的新闻（医药）

2025-07-29

·ioncology

ESMO 2025丨标题公布！消化道肿瘤领域口头报告一文速览

点击蓝字关注我们编者按2025年欧洲肿瘤内科学会年会（ESMO 2025）将于10月17~21日在德国柏林盛大举行。作为全球肿瘤学领域最具影响力的学术盛会之一，本届大会将集中呈现肿瘤诊疗领域的突破性研究进展。目前，大会官网已公布除LBA（Late-breaking Abstract）摘要外的全部入选研究标题。本文系统梳理了消化系统肿瘤领域Proffered Paper session和Mini oral session部分前沿成果，涵盖结直肠癌、胃癌、肝癌、胰腺癌、神经内分泌肿瘤等主要癌种，旨在为临床工作者和研究人员构建完整的研究进展图谱。期待ESMO 2025正式召开时，更多重磅数据的发布有望为全球消化系统肿瘤诊疗实践带来革命性突破。上消化道肿瘤Proffered Paper session 摘要号：2094O英文标题：SKYSCRAPER-07: A phase Ⅲ, randomised study of atezolizumab (atezo) with or without tiragolumab (tira) in patients (pts) with unresectable esophageal squamous cell carcinoma (ESCC) that has not progressed following definitive concurrent chemoradiotherapy (dCRT)中文标题：SKYSCRAPER-07：阿替利珠单抗（Atezo）联合或不联合Tiragolumab（Tira）治疗接受过根治性同步放化疗（dCRT）后未进展的不可切除食管鳞癌（ESCC）患者的Ⅲ期随机研究讲者：Ian Chau (Sutton, United Kingdom)Mini oral session 摘要号：2095MO 英文标题：Pembrolizumab and trastuzumab in combination with FLOT in the perioperative treatment of HER2-positive localized esophagogastric adenocarcinoma – Interim Analysis of the phase Ⅱ PHERFLOT/IKF-053 trial of the AIO study group (AIO STO 0321)中文标题：帕博利珠单抗联合曲妥珠单抗及FLOT方案用于HER2阳性局部食管胃腺癌围手术期治疗——AIO研究组Ⅱ期PHERFLOT/IKF-053试验的阶段性分析（AIO STO 0321）讲者：Eray Goekkurt (Hamburg, Germany)***************************************************************摘要号：2096MO英文标题：Systemic Therapy, Gastrectomy and CRS/HIPEC vs Systemic Therapy Alone for Gastric Cancer with Limited Peritoneal Dissemination: Results of the Randomised PERISCOPE Ⅱ Trial.中文标题：系统治疗、胃切除术联合CRS/HIPEC对比单纯系统治疗用于局限性腹膜播散胃癌：随机化PERISCOPE Ⅱ试验结果讲者：Judith S. Quik (Amsterdam, Netherlands)***************************************************************摘要号：1469MO英文标题：Liver resection versus continued atezolizumab plus bevacizumab (atezo/bev) in locally advanced hepatocellular carcinoma (HCC) after atezo/bev treatment (TALENTop): a multicenter, open-label, randomized phase Ⅲ trial.中文标题：局部晚期肝细胞癌（HCC）患者接受Atezo/Bev治疗后，肝切除术对比继续Atezo/Bev治疗（TALENTop）：多中心、开放标签、随机Ⅲ期试验讲者：Hui-Chuan Sun (Shanghai, China)讲者：复旦大学附属中山医院孙惠川***************************************************************摘要号：1470MO英文标题：Perioperative Camrelizumab plus Rivoceranib in Resectable Hepatocellular Carcinoma (CARES-009): A Randomized, Multicenter, Phase 3 Trial中文标题：围手术期卡瑞利珠单抗联合瑞戈非尼治疗可切除肝细胞癌（CARES-009）：随机、多中心、Ⅲ期试验讲者：复旦大学附属中山医院周俭***************************************************************摘要号：1471MO英文标题：Adding Ipilimumab (IPI) to Atezolizumab (ATEZO) plus Bevacizumab (BEV) in patients (pts) with unresectable hepatocellular carcinoma (uHCC) in first-line systemic therapy (1L): PRODIGE 81/FFCD 2101 - TRIPLET HCC中文标题：伊匹木单抗（IPI）联合阿替利珠单抗（ATEZO）和贝伐珠单抗（BEV）用于不可切除肝细胞癌（uHCC）的一线系统治疗（1L）：PRODIGE 81/FFCD 2101 - TRIPLET HCC试验讲者：Philippe Merle (LYON, France)***************************************************************摘要号：2214MO 英文标题：Phase 1 basket study of telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein–targeting antibody-drug conjugate: Results from patients (pts) with pancreatic ductal adenocarcinoma (PDAC)中文标题：针对c-Met蛋白的抗体药物偶联物Telisotuzumab Adizutecan（ABBV-400; Temab-A）的Ⅰ期篮式研究：胰腺导管腺癌（PDAC）患者的结果讲者：James J. Harding (New York, United States of America)***************************************************************摘要号：2215MO英文标题：HRS-4642 Combined with Gemcitabine and Nab-paclitaxel in KRAS-G12D Mutant Advanced Pancreatic Cancer: A Phase 1b/2 Study中文标题：HRS-4642联合吉西他滨和白蛋白结合型紫杉醇治疗KRAS-G12D突变晚期胰腺癌：1b/2期研究讲者：上海交通大学医学院附属仁济医院王理伟教授***************************************************************摘要号：2216MO英文标题：VIRAGE trial: randomized Phase Ⅱb, open-label, study of Nab-Paclitaxel and Gemcitabine with/without intravenous VCN-01 in Patients with Metastatic Pancreatic Cancer (mPDAC)中文标题：VIRAGE试验：随机Ⅱb期、开放标签研究，评估白蛋白结合型紫杉醇联合吉西他滨±静脉VCN-01治疗转移性胰腺癌（mPDAC）讲者：Rocio Garcia-Carbonero (Madrid, Spain)下消化道肿瘤Proffered paper session摘要号：726O英文标题：Prognostic value of the Combined Analysis of Pathologists and Artificial Intelligence (CAPAI) in high-risk stage Ⅱ-Ⅲ colon cancer treated without chemotherapy: interim report from a nationwide validation中文标题：病理学家与人工智能联合分析（CAPAI）对未接受化疗的高危Ⅱ-Ⅲ期结肠癌的预后价值：全国验证的阶段性报告讲者：Marie-Christine E. Bakker (Utrecht, Netherlands)***************************************************************摘要号：723O英文标题：Post-surgical liquid biopsy-guided treatment of stage Ⅲ and high-risk stage Ⅱ colon cancer patients: final results of the PEGASUS trial.中文标题：术后液体活检指导的Ⅲ期及高危Ⅱ期结肠癌治疗：PEGASUS试验最终结果讲者：Silvia Marsoni (Milan, Italy, (TO))***************************************************************摘要号：724O英文标题：Comparison of outcomes in clinical trials of locally advanced dMMR colon cancer: FOxTROT and NICHE-2中文标题：局部晚期dMMR结肠癌临床试验结果比较：FOxTROT与NICHE-2讲者：Jenny Seligmann (Leeds, United Kingdom, Yorkshire)***************************************************************摘要号：725O英文标题：Leveraging Artificial Intelligence to predict immune checkpoint inhibitor (ICI) efficacy in proficient MMR mCRC: translational analyses of AtezoTRIBE and AVETRIC trials中文标题：利用人工智能预测免疫检查点抑制剂（ICI）在MMR熟练型转移性结直肠癌（mCRC）中的疗效：AtezoTRIBE和AVETRIC试验的转化分析讲者：Martina Carullo (Pisa, Italy)Mini oral session摘要号：1MO英文标题：Placental features overexpression reveals hidden facets of early-onset colorectal cancer中文标题：胎盘特征过度表达揭示早发性结直肠癌的隐藏面讲者：Gianluca Mauri (Milan, Italy)***************************************************************摘要号：727MO英文标题：FOLFOX plus PANITUMUMAB (Pmab) according to a “stop-and-go” strategy in first-line in patients (pts) with non-mutated RAS/BRAF metastatic colorectal cancer (mCRC). Results of the FFCD 1605 – OPTIPRIME phase Ⅱ trial.中文标题： FOLFOX联合帕尼单抗（Pmab）"stop-and-go"策略治疗RAS/BRAF野生型转移性结直肠癌（mCRC）患者的一线治疗：FFCD 1605-OPTIPRIME Ⅱ期试验结果讲者：Jean-Baptiste Bachet (Paris, France)***************************************************************摘要号：728MO英文标题：Predictive Value of Low-Frequency Resistance Mutations and Relative Mutant Allele Frequencies (rMAFs) in Anti-EGFR Rechallenge for RAS/BRAF Wild-Type (wt) Metastatic Colorectal Cancer (mCRC)中文标题：低频耐药突变及相对突变等位基因频率（rMAFs）在RAS/BRAF野生型转移性结直肠癌（mCRC）抗EGFR再挑战中的预测价值讲者：Pau Mascaró Baselga (Barcelona, Spain)***************************************************************摘要号：729MO英文标题：Circulating tumor (ct) DNA analysis of BRAF V600E dynamics and changes in genomic landscape in patients (pts) with first-line (1L) BRAF V600E-mutant metastatic colorectal cancer (mCRC) treated in BREAKWATER中文标题：循环肿瘤（ct）DNA分析BRAF V600E动态及基因组图谱变化：BREAKWATER试验中一线（1L）BRAF V600E突变转移性结直肠癌（mCRC）患者讲者：Scott Kopetz (Houston, United States of America)***************************************************************摘要号：730MO英文标题：Trifluridine/Tipiracil in combination with Capecitabine and Bevacizumab as upfront treatment for metastatic colorectal cancer: first results of the phase Ⅱ TriComB study by GONO中文标题：曲氟尿苷/替匹嘧啶联合卡培他滨和贝伐珠单抗作为转移性结直肠癌的初始治疗：GONO Ⅱ期TriComB研究的初步结果讲者：Veronica Conca (Pisa, Italy)***************************************************************摘要号：731MO英文标题：Telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with bevacizumab (Bev) vs standard of care (SOC) in patients (pts) with 3L+ colorectal cancer (CRC): Dose expansion results of a phase 1 study中文标题：Telisotuzumab Adizutecan（ABBV-400; Temab-A）联合贝伐珠单抗（Bev）对比标准治疗（SOC）用于3线及以上结直肠癌（CRC）：Ⅰ期研究剂量扩展结果讲者：Michael Cecchini (New Haven, United States of America)神经内分泌肿瘤与内分泌肿瘤Proffered Paper session摘要号：1705O英文标题：LITESPARK-015: Belzutifan in advanced pheochromocytoma and paraganglioma中文标题：LITESPARK-015：Belzutifan治疗晚期嗜铬细胞瘤和副神经节瘤讲者：Camilo Jimenez (Houston, United States of America)***************************************************************摘要号：1706O英文标题：Efficacy, safety and subgroup analysis of 177Lu-edotreotide vs everolimus in patients with Grade 1 or Grade 2 GEP-NETs: Phase 3 COMPETE trial中文标题：177Lu-edotreotide对比依维莫司治疗1~2级胃肠胰神经内分泌肿瘤（GEP-NETs）的疗效、安全性及亚组分析：Ⅲ期COMPETE试验讲者：Jaume Capdevila (Barcelona, Spain)***************************************************************摘要号：2987O英文标题：Efficacy and Safety of Dabrafenib Plus Trametinib (D+T) in Patients With Radioactive Iodine (RAI)-Refractory BRAF V600-Mutant Differentiated Thyroid Cancer (DTC)中文标题：达拉非尼联合曲美替尼（D+T）治疗放射性碘（RAI）难治性BRAF V600突变分化型甲状腺癌（DTC）的疗效与安全性讲者：津市人民医院高明教授Mini oral session摘要号：1707MO英文标题：A Phase 2 Dose Expansion Study of ZG006, a Trispecific T Cell Engager Targeting DLL3/DLL3/CD3, as Monotherapy in Patients with Refractoy Neuroendocrine Carcinoma中文标题：ZG006（靶向DLL3/DLL3/CD3的三特异性T细胞衔接器）单药治疗难治性神经内分泌癌的Ⅱ期剂量扩展研究讲者：中国人民解放军总医院赵传华***************************************************************摘要号：1708MO英文标题：ZG005 in combination with etoposide and cisplatin for the first-line treatment of advanced neuroendocrine carcinoma中文标题：ZG005联合依托泊苷和顺铂用于晚期神经内分泌癌的一线治疗讲者：Sisi Ye (Beijing, China)***************************************************************摘要号：1709MO英文标题：Multi-center NCI-sponsored phase 1 study of triapine in combination with 177Lu-dotatate in patients with well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs)中文标题：多中心NCI资助的Ⅰ期研究：Triapine联合177Lu-dotatate治疗分化良好的胃肠胰神经内分泌肿瘤（GEP-NETs）讲者：Aman Chauhan (Deerfield Beach, United States of America)***************************************************************摘要号：1033MO英文标题：[212Pb]VMT-α-NET targeted alpha-particle therapy (TAT) for advanced somatostatin receptor 2 positive (SSTR2+) neuroendocrine tumours (NETs): mature safety and preliminary efficacy for enrollment from dose-finding cohorts 1 and 2 (n=44)中文标题：[212Pb]VMT-α-NET靶向α粒子治疗（TAT）用于晚期生长抑素受体2阳性（SSTR2+）神经内分泌肿瘤（NETs）：剂量探索队列1和2（n=44）的成熟安全性和初步疗效讲者：Thorvardur R. Halfdanarson (Rochester, United States of America)***************************************************************摘要号：1034MO英文标题：Long-term Follow-up of Peptide Receptor Radionuclide Therapy (PRRT)-Naïve Patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) Treated with Targeted Alpha Therapy 212Pb-DOTAMTATE in the Phase 2 ALPHAMEDIX 02 Trial中文标题：212Pb-DOTAMTATE靶向α治疗在未接受过肽受体放射性核素治疗（PRRT）的胃肠胰腺神经内分泌肿瘤（GEP-NETs）患者中的长期随访：一项Ⅱ期ALPHAMEDIX 02临床试验结果讲者：Jonathan R. Strosberg (Tampa, United States of America)***************************************************************摘要号：1035MO英文标题：A Prediction Tool for Malnutrition and Sarcopenia in Patients with Gastroenteropancreatic (GEP) Neuroendocrine Neoplasms (NENs): Results from NUTRIGETNE (GETNE-S2109) Study中文标题：胃肠胰神经内分泌肿瘤（NENs）患者营养不良和肌肉减少症的预测工具：NUTRIGETNE（GETNE-S2109）研究结果讲者：Maribel Del Olmo (Valencia, Spain)***************************************************************摘要号：1710MO英文标题：Belzutifan for Advanced Pancreatic Neuroendocrine Tumors (panNETs): Results From Cohort A2 of the Phase 2 LITESPARK-015 Study中文标题：Belzutifan治疗晚期胰腺神经内分泌肿瘤（panNETs）：Ⅱ期LITESPARK-015研究A2队列结果讲者：Jaume Capdevila (Barcelona, Spain)***************************************************************摘要号：2988MO英文标题：Patient-Derived Organoids Predict Clinical Response and Guide Personalized Therapy in Advanced Thyroid Cancer中文标题：患者来源的类器官预测晚期甲状腺癌临床反应并指导个性化治疗讲者：Jiaye Liu (Chengdu, China)（来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期临床3期临床结果临床成功

2025-06-26

·Business Wire

Orano Med Inaugurates Expansion of its U.S. Research and Development Center in Texas

PARIS--(BUSINESS WIRE)--Orano Med, a subsidiary of the Orano Group and a pioneer in radioligand therapies in oncology, today inaugurated the expansion of its main Research and Development Center located in Plano, Texas (USA). This strategic facility is dedicated to developing novel radiopharmaceuticals and conducting preclinical research focused on targeted alpha therapies using lead-212 (212Pb), an innovative and promising approach against various types of cancer. The site hosts the R&D teams of Orano Med as well as those of its subsidiary Macrocyclics, a manufacturer of customized chelating agents. “The expansion of our R&D center enhances our ability to develop lead-212-based radioligand therapies by giving our teams the resources they need to advance a growing pipeline of drug candidates through to the clinic." With an investment of over $5 million, Orano Med has expanded its R&D Center by approximately 11,000 ft². The expansion includes around 5,000 ft² of new laboratory space, enabling the advancement of a growing pipeline and doubling the Good Manufacturing Practice (GMP) production capacity for early clinical trial supply. In addition, about 5,500 ft² of new office space has been added to accommodate the site's growing team, whose headcount has doubled over the past four years. Overall, this represents about a 50% increase in space compared to the pre-existing facility. Julien Torgue, Chief Scientific Officer of Orano Med, stated: “The expansion of our R&D center enhances our ability to develop lead-212-based radioligand therapies by giving our teams the resources they need to advance a growing pipeline of drug candidates through to the clinic. With an integrated platform, cutting-edge equipment and a focused scientific strategy, we are well positioned to support both our internal developments and collaborations with partners.” Orano Med’s R&D platform is fully integrated, combining cutting-edge equipment and a highly experienced team to advance the development of next-generation cancer therapies. The company can carry out the full range of preclinical development studies, including in vivo and Chemistry, Manufacturing and Controls (CMC) studies, onsite. Orano Med conducts both in-house research programs and collaborative developments with biotech and pharmaceutical partners. This integrated approach ensures a rapid and reliable transition from research to clinical phases. While the primary mission of the research and development center is therapeutic development, the facility also serves as production hub for lead-212 based drug candidates for early-stage clinical trials in the U.S. This expansion demonstrates Orano Med’s strong commitment to innovation and leadership in the field of radioligand therapies, accelerating the development of new treatment options for patients worldwide. A celebration was held on-site with local teams and Orano Med’s Executive Committee to mark this important milestone. During the event, Orano Med also unveiled the new name of the facility: Drug Development and Preclinical Unit (DDPU) – George de Hevesy Center Arnaud Lesegretain, President and Chief Executive Officer of Orano Med, added: “This expansion marks an important step in Orano Med’s growth at our Plano site, which has played a key role since the inception of the company 15 years ago. It reinforces our world-class R&D capabilities in the U.S. and strengthens our ability to deliver innovative targeted alpha therapies by supporting early-stage development in a fully integrated environment.” About Orano Med Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). AlphaMedix, its most advanced asset in clinical development for GEP-NETs tumors, received Breakthrough Designation from the FDA in 2024. The company is advancing several potential treatments using 212Pb combined with various targeting agents through clinical and preclinical studies. Orano Med has 212Pb manufacturing facilities, laboratories, and R&D centers in France and in the US. It is expanding its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe and building a unique, independent, and fully integrated industrial platform to serve the needs of patients globally. For more information, please visit: http://www.oranomed.com About Orano As a recognized international leading operator in the field of nuclear materials, Orano delivers solutions to address present and future global energy and health challenges. Its expertise and mastery of cutting-edge technologies enable Orano to offer its customers high value-added products and services throughout the entire fuel cycle. Every day, the Orano group’s 17,500 employees draw on their skills, unwavering dedication to safety and constant quest for innovation, with the commitment to develop know-how in the transformation and control of nuclear materials, for the climate and for a healthy and resource-efficient world, now and tomorrow. Orano, giving nuclear energy its full value. About Targeted Alpha Therapy Targeted alpha therapy (TAT) relies on a simple concept: combining the ability of biological molecules to target cancer cells with the short-range cell-killing capabilities of alpha-emitting radioisotopes. Alpha decay consists of the emission of a helium nucleus (alpha particle) together with very high linear energy transfer and a range emission of only few cell layers, resulting in irreparable double strand DNA breaks in cells adjacent only to area of alpha emission. This approach results in an increased cytotoxic potential toward cancer cells while limiting toxicity to nearby healthy cells. As a result, alpha emitters are considered as the most powerful payloads to be found for targeted therapies.

放射疗法

2025-06-23

·PipelineReview

Molecular Partners and Orano Med present preclinical data on mesothelin-targeting Radio-DARPin candidate MP0726 at SNMMI 2025

ZURICH-SCHLIEREN, Switzerland and CONCORD, MA, USA and PARIS, France I June 22, 2025 I Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics (“Molecular Partners” or the “Company”) and Orano Med, a clinical-stage radiopharmaceutical company and a pioneer in the development of targeted alpha-particle therapies (TAT) with 212 Pb (lead-212), today announced the debut of MP0726, its Radio-DARPin candidate targeting mesothelin (MSLN) and will present preclinical data in an oral presentation at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), taking place June 21-24 in New Orleans, LA, USA. The oral presentation outlines encouraging early preclinical proof-of-concept data showing that MP0726 binds with high affinity and selectivity to the membrane-proximal domain of MSLN without being impacted by shed MSLN. In vivo results in a MSLN tumor model show a favorable biodistribution with substantial uptake of the Radio-DARPin in MSLN-positive tumors, while other organs showed limited accumulation. At 24 hours post injection, tumor accumulation was up to 34%, resulting in a tumor to kidney ratio of up to 4.5. MP0726 leverages the unique properties of DARPins to selectively bind membrane-bound MSLN, a promising target for ovarian cancer due to its differentiated expression profiles – high in tumor, and lower in healthy tissues. High levels of shed MSLN can act as a decoy receptor and have historically hampered the development of MSLN-targeted therapeutics. MP0726 is being co-developed under Molecular Partners’ strategic partnership with Orano Med. “Our collaboration with Molecular Partners has been delivering substantial progress in a short time, reflecting the skills, passion and strong complementarity of our teams. This progress highlights the effectiveness of our joint R&D efforts, enabling us to identify and advance differentiated clinical candidates that address important unmet medical needs. With its world-class R&D capabilities, the ownership of a virtually unlimited supply of the starting isotope, and fully-integrated manufacturing supply chain, Orano Med is uniquely positioned to support the development of these important potential new medicines”, said Arnaud Lesegretain, CEO of Orano Med. “We are proud to advance our second Radio-DARPin candidate into development, together with our partner Orano Med, for patients with MSLN expressing cancers. The promising preclinical data indicate a favorable biodistribution profile and highlight the unique approach to targeting MSLN with MP0726,” said Patrick Amstutz, Ph.D., CEO of Molecular Partners. MP0726 represents the second Radio-DARPin program to move into pre-clinical development. The first Radio-DARPin program, MP0712 targeting DLL3, is on track to dosing the 1 st patient in a Phase 1 study in the US in the second half of 2025. Details of the presentation: Preclinical characterization of a Lead-212 Radio-DARPin Therapeutic to selectively target membrane-bound mesothelin in solid tumors Date & Time: 24 June 2025; 2:50-3:00 pm CST Session: SS38 Radiopharmaceutical Oncology – Preclinical and Early Phase (2:30-3:45 pm CST) About 212 Pb-based Radio-DARPins Molecular Partners’ Radio-DARPin platform is being developed to provide a unique and innovative delivery system for radioactive payloads, with exquisite targeting capabilities of DARPins combined with the optimally balanced safety and tumor killing of 212 Pb. DARPins are ideal vectors for efficient delivery of therapeutic radionuclides to solid tumors, while overcoming some historic limitations of radioligand therapy approaches, thanks to their small size as well as high specificity and affinity. Molecular Partners and Orano Med are developing targeted alpha radio-therapeutics against up to ten targets, including the tumor-associated protein Delta-like ligand 3 (DLL3) and mesothelin (MSLN). About Molecular Partners AG Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN) is a clinical-stage biotech company pioneering the design and development of DARPin therapeutics for medical challenges other drug modalities cannot readily address. The Company has programs in various stages of pre-clinical and clinical development, with oncology as its main focus. Molecular Partners leverages the advantages of DARPins to provide unique solutions to patients through its proprietary programs as well as through partnerships with leading pharmaceutical companies. Molecular Partners was founded in 2004 and has offices in both Zurich, Switzerland and Concord, MA, USA. For more information, visit www.molecularpartners.com and find us on LinkedIn and Twitter / X @MolecularPrtnrs About Orano Med Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 ( 212 Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). AlphaMedix, its most advanced asset in development for GEP-NETs tumors, received Breakthrough Designation from the FDA in 2024. The company develops several treatments using 212 Pb combined with various targeting agents. Orano Med has 212 Pb manufacturing facilities, laboratories, and R&D centers in France and in the US. It is expanding its GMP-manufacturing capacities for 212 Pb radiolabeled pharmaceuticals in North America and Europe and building a unique, independent, and fully integrated industrial platform to serve the needs of patients globally. For more information, please visit: www.oranomed.com . SOURCE: Orano Med

100 项与 212Pb-AR-RMX 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
神经内分泌肿瘤	临床3期	美国	Orano Med SAS	2021-12-01
生长抑素受体阳性神经内分泌肿瘤	临床2期	美国	Orano Med LLC	2021-12-21

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05153772 (ALPHAMEDIX 02, ASCO2024)	临床2期	胃肠胰神经内分泌肿瘤 SSTR+	-	212Pb-DOTAMTATE	膚繭鑰衊蓋鹹鹹廠艱鹹(醖製構壓衊蓋窪廠艱積) = 構願窪窪選簾窪積壓鬱構鏇鹹衊願鑰構築窪夢 (襯齋積蓋鹹鏇糧網醖顧, 32.0 ~ 63.0)	积极	2024-05-24
NCT05153772 (ALPHAMEDIX 02, ASCO2024)	临床2期	胃肠胰神经内分泌肿瘤 SSTR+	-	177Lu-DOTATATE	膚繭鑰衊蓋鹹鹹廠艱鹹(醖製構壓衊蓋窪廠艱積) = 夢鏇襯衊廠鹹築選願顧構鏇鹹衊願鑰構築窪夢 (襯齋積蓋鹹鏇糧網醖顧, 10 ~ 25)	积极	2024-05-24
212Pb-DOTAMTATE (SNMMI2022)	N/A	神经内分泌肿瘤 SSTR expressing	11	212Pb-DOTAMTATE at 67.6 µCi/kg/cycle	窪顧積艱艱範醖願憲築(夢淵憲膚網襯鹹壓範憲) = 襯簾簾構觸淵築壓憲齋鑰觸糧鏇繭齋簾衊築餘 (鹽壓壓膚糧網餘簾願顧 )	积极	2022-08-08
NCT03466216 (ASCO2022) 人工标引	临床1期	神经内分泌肿瘤	10	212Pb-DOTAMTATE	齋淵觸餘窪簾衊鬱糧選(願繭繭遞衊壓壓鹹衊鑰) = 艱網簾蓋鹹製獵構糧獵願鹽襯簾製積壓壓顧糧 (網窪網壓獵網窪製積繭 ) 更多	积极	2022-06-02
NCT03466216 (ASCO 12021 \| ASCO 22021) 人工标引	临床1期	神经内分泌肿瘤一线 SSTR Expression	20	AlphaMedix	餘糧網遞繭遞蓋餘糧窪(夢鬱繭衊顧顧廠願襯鹽) = 膚憲艱淵獵製糧選簾鬱範積選襯廠鏇簾艱範夢 (觸鹹憲簾築窪夢鏇艱淵 ) 更多	积极	2021-05-20
AlphaMedix (EANM2020)	N/A	神经内分泌肿瘤 SSTR-	16	AlphaMedix 30.7 ÂµCi/kg	積鬱獵繭鏇壓鏇淵鏇衊(鹹選鹹鹹鹹鏇製網積憲) = 7/16 (43%) 鑰憲繭齋糧範構顧簾鹹 (網選顧壓鏇繭範鑰簾顧 ) 更多	积极	2020-09-18
AlphaMedix (EANM2020)	N/A	神经内分泌肿瘤 SSTR-	16	AlphaMedix 40.0 ÂµCi/kg		积极	2020-09-18
FDA IND 135150 (AACR2020)	N/A	神经内分泌肿瘤	13	AlphaMedixTM	壓構鹹鹹築獵選鑰衊鏇(齋構構製鏇壓壓範醖廠) = No clinically significant investigational drug-related hematological and renal toxicity was noted. 築顧願鏇膚網選網鑰顧 (鬱鏇製膚繭範鏇簾顧蓋 ) 更多	积极	2020-08-15
ESMO2019	N/A	APUD瘤	170	High doses analogs of somatostatin (SSA)	構鏇淵網顧壓糧鏇壓願(遞衊糧構願襯積繭窪蓋) = 12% 製範醖觸繭鏇齋憲憲願 (淵網鏇壓遞鹽鬱顧蓋壓 ) 更多	-	2019-09-29
ASCO2015	N/A	胸腺上皮肿瘤	-	Octreotide/lanreotide plus prednisone	廠醖鹽淵鹽製夢醖夢鬱(淵鏇製廠積夢顧範鏇繭) = 鏇遞積窪鬱糧憲憲鹽鬱窪淵顧襯齋鑰鬱壓廠糧 (窪餘觸願繭膚獵網願鏇 ) 更多	积极	2015-05-20