Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

开始日期2024-10-01

申办/合作机构

Blue Earth Diagnostics Ltd.初创企业

[+1]

NCT06617481 / Recruiting临床2期IIT

RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence

Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.
The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.

开始日期2024-09-20

申办/合作机构

AdventHealth Waterman

[+1]

NCT06055790 / Recruiting临床2期IIT

Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis

The goal of this diagnostic intervention clinical trial is to compare 18F-Fluciclovine uptake within brain lesions over 60 minutes compared with standard of care positive histology confirmation or confirmation MRI images. The main questions it aims to answer are:
1. What are the dynamics of 18F-Fluciclovine update within a non-treated metastatic brain lesion over 60 minutes?
2. What are the dynamics of 18F-fluciclovine update within recently treated metastatic brain lesions?
3. What is the potential use of 18F-Fluciclovine in delineating true local progression from radionecrosis in patients with clinical uncertainty of indeterminate MRI?
Participants will undergo an 18F-fluciclovine head PET/CT scan prior to treatment for brain metastatic lesion(s). The study will characterize uptake dynamic PET images over 60 minutes. Uptake within the lesions and the benign brain parenchyma will be plotted on a time activity curve for 60 mins. Patients will undergo a second 18F-fluciclovine PET/CT to evaluate 18F-fluciclovine uptake in treated lesions over 60 minutes. This will be offered concurrently with the post-procedure standard of care (SOC) MRI to evaluate post-treatment changes. Uptake within the lesions and the benign brain parenchyma will be plotted on a 60 min time activity curve. Results will be compared to the pre-treatment baseline images. A third 18F-fluciclovine PET/CT will be offered to evaluate post radiation changes necrosis from recurrence, for up to 10 patients in our cohort who are under clinical surveillance (up to three years surveillance) and developed MRI evidence of either true progression or radionecrosis with clinical uncertainty after stereotactic radiosurgery. The initial 18F-fluciclovine PET/CT will serve as a baseline PET/CT scan. This will be compared to post procedural histological confirmation.

开始日期2024-09-10

申办/合作机构

University of Arizona

[+1]

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项与 Blue Earth Diagnostics Ltd. 相关的文献（医药）

2024-08-01·Journal of Nuclear Medicine

Interreader and Intrareader Reproducibility of¹⁸F-Flotufolastat Image Interpretation in Patients with Newly Diagnosed or Recurrent Prostate Cancer: Data from Two Phase 3 Prospective Multicenter Studies

Article

作者: Yoo, Don ; Schuster, David M ; Esposito, Giuseppe ; Davis, Phillip ; Miller, Matthew P ; Zukotynski, Katherine ; Chau, Albert ; Chapin, Brian F ; Ravizzini, Gregory C ; Ulaner, Gary A ; Penny, Ross ; Kuo, Phillip H

Interreader and intrareader reproducibility of ¹⁸F-flotufolastat PET/CT scans in newly diagnosed and recurrent prostate cancer patients was assessed from masked image evaluations from two phase 3 studies. Methods: ¹⁸F-flotufolastat PET/CT images of newly diagnosed (n = 352) or recurrent (n = 389) patients were evaluated by 3 masked readers. Cohen κ was used to assess pairwise patient- and region-level interreader agreement. Agreement among all readers was assessed using Fleiss κ. Intrareader agreement between the first and repeat read (20% of images, ≥4 wk later) was assessed using Cohen κ. Results: Pairwise interreader agreement was 95% or better (newly diagnosed) and 75% or better (recurrent). The κ coefficients were impacted by the high-agreement-low-κ paradox: Cohen κ ranged from not estimable to 0.55, whereas Fleiss κ was 0.50 (newly diagnosed) and 0.41 (recurrent). Agreement was highest in the prostate of newly diagnosed patients (≥95%) and in the pelvic lymph nodes in recurrent patients (≥87%). Intrareader agreement was 86% or better across both populations. Conclusion: ¹⁸F-flotufolastat PET/CT images can be reliably interpreted, with a high degree of inter- and intrareader agreement.

2024-07-01·Journal of Nuclear Medicine

True-Positive¹⁸F-Flotufolastat Lesions in Patients with Prostate Cancer Recurrence with Baseline-Negative Conventional Imaging: Results from the Prospective, Phase 3, Multicenter SPOTLIGHT Study

Article

作者: Hermsen, Rick ; Chau, Albert ; Fleming, Mark T ; Davis, Phillip ; Chapin, Brian F ; Purysko, Andrei S ; Schuster, David M

¹⁸F-rhPSMA-7.3 (¹⁸F-flotufolastat) is a high-affinity prostate-specific membrane antigen-targeted diagnostic radiopharmaceutical for PET imaging in patients with prostate cancer. Here, we report findings from the SPOTLIGHT study (NCT04186845), assessing the performance of ¹⁸F-flotufolastat PET/CT for identifying prostate-specific membrane antigen-positive lesions confirmed by standard of truth (SoT) in men with biochemical recurrence of prostate cancer and negative conventional imaging at baseline. Methods: Men with biochemical recurrence received 296 MBq of ¹⁸F-flotufolastat intravenously and then underwent PET/CT 50-70 min later. ¹⁸F-flotufolastat PET/CT findings were evaluated by 3 masked central readers and verified using histopathology or follow-up confirmatory imaging (CT, MRI, bone scan, or ¹⁸F-fluciclovine PET/CT) as the SoT. The present analysis evaluated all patients who had negative conventional imaging at baseline, underwent ¹⁸F-flotufolastat PET/CT, and had SoT verification by histopathology or follow-up confirmatory imaging to report detection rate (DR), which is the number of patients with at least 1 PET-positive lesion, divided by the number of evaluable patients, and verified DR (VDR), which is the proportion of patients with at least 1 true-positive lesion as verified by SoT, of all patients scanned (PET-positive and PET-negative scans). DR and VDR were calculated and stratified according to prior therapy. Majority read data (agreement between ≥2 readers) are reported. Results: In total, 171 patients with negative baseline conventional imaging and SoT by histopathology or post-PET confirmatory imaging were evaluated. By majority read, the overall ¹⁸F-flotufolastat DR among these patients was 95% (163/171; 95% CI, 91.0%-98.0%), and 110 of 171 of these patients had at least 1 true-positive lesion identified (VDR, 64%; 95% CI, 56.7%-71.5%). In the postprostatectomy group (133/171), 8.3% of patients had at least 1 true-positive lesion in the prostate bed, 28% in pelvic lymph nodes, and 35% in other sites. Among those who had received radiotherapy (36/171), 50% of patients had true-positive detections in the prostate, 8.3% in pelvic lymph nodes, and 36% in other sites. Conclusion: ¹⁸F-flotufolastat frequently identified true-positive prostate cancer lesions in patients with negative conventional imaging. ¹⁸F-flotufolastat may help to better define sites of disease recurrence and inform salvage therapy decisions than does conventional imaging, potentially leading to improved outcomes.

2024-02-01·Molecular Imaging and Biology

Quantitative and Qualitative Assessment of Urinary Activity of 18F-Flotufolastat-PET/CT in Patients with Prostate Cancer: a Post Hoc Analysis of the LIGHTHOUSE and SPOTLIGHT Studies

Article

作者: Postema, Ernst J ; Penny, Ross ; Kuo, Phillip H ; Hermsen, Rick

AbstractPurposeTo evaluate the impact of urinary activity on interpretation of 18F-flotufolastat (18F-rhPSMA-7.3) PET/CT, we conducted a post hoc qualitative and quantitative analysis of scans acquired in two phase 3 studies of 18F-flotufolastat.ProceduresNewly diagnosed or recurrent prostate cancer patients enrolled in LIGHTHOUSE (NCT04186819) or SPOTLIGHT (NCT04186845), respectively, underwent PET/CT 50–70 min after intravenous administration of 296 MBq 18F-flotufolastat. For the present analysis, 718 18F-flotufolastat scans (352 from LIGHTHOUSE and 366 from SPOTLIGHT) were re-evaluated by three board-certified nuclear medicine physicians. Reader 1 performed a quantitative assessment (SUVmax and SUVmean) of bladder activity in a circular region-of-interest over the maximum diameter of bladder activity in the transverse plane. All three readers qualitatively assessed the impact of any urinary activity in the bladder on image interpretation using a three-point scale (0 = no/minimal visible urinary activity, 1 = urinary activity visible but distinction between urine and disease possible and 2 = assessment inhibited by urinary activity) and the presence/absence of ureteric activity and halo artifacts.ResultsIn total, 712/718 scans were evaluable. Reasons for exclusion were cystectomy, renal failure, or urinary catheter in situ (n = 2 each). The median bladder SUVmax and SUVmean were 17.1 and 12.5, respectively. By majority read, 682/712 (96%) patients had either no urinary activity (score = 0) or visible activity that could be distinguished from disease uptake (score = 1). In the minority of patients (24, 3.4%) where urinary activity did impact assessment (score = 2), the median bladder SUVmean was higher (20.5) than those scored 0 (3.8) or 1 (14.0). Ureteric activity was absent in 401 (56%) patients. Halo artifacts were observed in only two (0.3%) patients (majority read).Conclusions18F-Flotufolastat urinary activity did not influence disease assessment for the majority of patients. While this study was not designed as a head-to-head comparison, the median bladder SUVs are lower than previously reported values for other renally cleared PSMA-PET radiopharmaceuticals.

项与 Blue Earth Diagnostics Ltd. 相关的新闻（医药）

2024-10-30

·PRNewswire

Blue Earth Therapeutics Ltd announces completion of $76.5M Series A financing to accelerate development of next generation targeted radioligand therapies

Several external investors, including Soleus Capital and Sands Capital Management, join with initial investor Bracco Imaging S.p.A. in the financing Resources support Phase 2 studies for Lutetium (177Lu) rhPSMA-10.1 and Actinium (225Ac) rhPSMA-10.1, and development of differentiating data compared to 1st generation prostate cancer radioligand therapies OXFORD, United Kingdom, Oct. 30, 2024 /PRNewswire/ -- Blue Earth Therapeutics Ltd, an emerging leader in the development of therapeutic radiopharmaceuticals, today announced closing of a $76.5M Series A financing. The round was led by Soleus Capital and co-led by Sands Capital Management with existing investor Bracco Imaging SpA also participating. Woodline Partners and PBM Capital also joined in the financing as new institutional investors. The new funding comes from a broad spectrum of experienced biotech investors and enables Blue Earth Therapeutics to further advance its clinical stage PSMA-targeted radioligand therapies. "With the new investors and the team we have assembled, we now have a great mix of expertise and the resources to further our mission to develop radioligand therapies with the potential to improve patient outcomes by delivering high radiation doses to tumours without compromising on normal organ safety," said David Gauden, Blue Earth Therapeutics CEO. "With our recent announcement on completion of the Phase 1 clinical trial, we are making excellent progress on both our beta emitter Lutetium (177Lu) rhPSMA-10.1 and alpha emitter Actinium (225Ac) rhPSMA-10.1 agents and look forward to sharing further progress updates." "The establishment of PSMA-targeted radiopharmaceuticals as a class of therapy in prostate cancer represents a huge opportunity to improve outcomes for prostate cancer patients. Our new investors share our strong belief that Blue Earth Therapeutics' radiohybrid agents could be a significant improvement over currently approved treatment options," said Fulvio Renoldi Bracco, CEO of Bracco Imaging SpA. "We have observed the rapid acceptance of Pluvicto® as the first PSMA-targeted radioligand therapy for the treatment of prostate cancer, and at the same time see opportunities to do better," said David Canner, partner at Soleus Capital. "The early data the company has developed supports differentiation and gives us confidence to invest in the Blue Earth team. We look forward to advancing Blue Earth Therapeutics' compounds to later stage trials." David Canner from Soleus Capital and Michael Ginder from Sands Capital Management are joining the Board of Directors alongside representatives from Bracco Imaging SpA and experienced industry CEO David Gauden. About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA) rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. About Blue Earth Therapeutics Blue Earth Therapeutics is a clinical stage company dedicated to advancing next generation targeted radiotherapeutics to treat patients who have cancer and has been incubated within the Bracco family of companies. With proven management expertise across the spectrum of radiopharmaceutical and oncology drug development, as well as biotechnology start‐up experience, the Company aims to innovate and improve upon current technologies and rapidly advance new targeted therapies for serious diseases. Blue Earth Therapeutics has an emerging pipeline initially focused on prostate cancer. For more information, please visit: . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world‐leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X‐ray imaging (including Computed Tomography‐CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose‐management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting‐edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: . Contacts: For Blue Earth Therapeutics Robert Dann Vice President, Strategy & Planning (617) 631-0234 [email protected] Media Edelman Inc. Amanda Lazaro (M) +1 617 775-1306 [email protected] SOURCE Blue Earth Therapeutics Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

并购引进/卖出放射疗法

2024-10-30

·EndPoints

Blue Earth Therapeutics snags $76M for both alpha and beta radiotherapies

The radiopharma field continues to buzz with private financings and more clinical-stage programs. The latest is Oxford, UK-based Blue Earth Therapeutics, which unveiled a $76.5 million Series A on Wednesday morning to bring its lutetium-based radioligand therapy into Phase 2 and its actinium-based asset into Phase 1. Both of those trials will begin in early 2025, CEO David Gauden told Endpoints News . The funding adds to a steady drumbeat of investor and pharma interest in the field. Alpha-9 Oncology bagged a $175 million Series C last week, the same amount that Aktis Oncology secured in a Series B last month. Gauden said the company will have key clinical data in about 12 to 18 months, at which point it could entertain pharma partnerships, another private funding round or an IPO if the markets are right. Industry interest is certainly there. Lilly, Novartis and Bristol Myers have all made radiopharma deals in the past 12 months. But a few other big pharmas haven’t “taken the plunge,” Gauden said, meaning there could be even more dealmaking activity in the years to come. Blue Earth seeks to make better PSMA-targeted radiopharmaceuticals than the first generation, which Novartis broke open with Pluvicto, Gauden said. The company hopes to double the amount of radiation delivered to prostate cancer lesions without compromising safety and side effects on normal organs, he added. Blue Earth works with external manufacturers, and it has three partners that can make drug product with access to about half a dozen suppliers for lutetium, Gauden said. Actinium 225-based radiopharmaceuticals have run into some supply constraints. Gauden said Blue Earth has enough for its upcoming Phase 1 and that the actinium supply chain should be where lutetium is today in about three to four years. The startup will continue to have “some shared activities and resources” with its sister company Blue Earth Diagnostics for about another year, Gauden said, but they’re “largely independent” at this point. Gauden became CEO of the therapeutics company in July after serving in the same post at the diagnostics business, which has FDA-approved imaging agents . Both are backed by Milan-based Bracco Imaging. In addition to Bracco, Blue Earth Therapeutics’ investors also include Soleus Capital, Sands Capital Management, Woodline Partners and PBM Capital.

高管变更

2024-10-23

·同写意

放射性药物革命：从诊断到治疗

在过去的几十年里，放射性药物经历了重大的转变。最初，这些药物主要用于成像，以便早期诊断癌症和其他疾病。随着治疗和诊断技术的结合，放射性药物的发展已经彻底改变了这个领域。诊疗一体化的放射性药物既能检测疾病，又能治疗疾病，为医疗提供了更具个性化的方法。正如Lantheus首席执行官Brian Markison所指出的那样，“放射性药物可以发现、战斗和跟踪。这些药物具有靶向特定癌细胞的独特能力，可提供诊断成像，并递送靶向治疗辐射来摧毁癌细胞”。放射性药物市场呈指数级增长。一份Statista市场研究报告显示，预计到2032年，放射性药物领域的价值将达到140亿美元，而目前还未达到70亿美元。“这种增长将受到诊断和治疗放射性药物的创新、接受治疗的患者数量的增加，以及这些技术在各种癌症和神经病学中应用扩大的驱动。”Markison补充道。 1 发现、对抗、跟随放射性药物正在成为一种强大的精准医学，能够“发现”、“对抗”和“跟踪”癌细胞。放射性药物包括一种靶向剂，结合放射性同位素，与癌细胞上的特定生物靶点结合。这种组合可以精确地将辐射输送到肿瘤，同时最大限度地减少对周围健康组织的伤害。这种方法使药物能够寻找到癌细胞，用靶向辐射摧毁，并跟踪治疗的有效性。在“发现”阶段，放射性药物与肿瘤特异性抗原或受体结合，如前列腺特异性膜抗原（PSMA），用于前列腺癌的治疗。附着的放射性同位素会发出γ射线，可以通过PET（正电子发射断层显像术）或SPECT（单光子发射计算机断层显像术）等成像技术探测到，这使得临床医生能够可视化肿瘤的位置和大小。 “战斗”阶段包括将β或α粒子输送到癌细胞的放射性治疗。 “大多数已确立的疗法使用发射β粒子。这些粒子（比如镥-177）在体内传播的距离相对较远，会导致单链DNA断裂，从而破坏癌细胞的生长。”Back Bay Life Science Advisors管理合伙人Peter Bak解释道。而发射α粒子（比如使用锕-225或铅-212粒子）可以造成短程辐射，这些粒子会导致双链DNA断裂。这意味着，α射线会不可逆转地破坏癌细胞，而不会损害肿瘤附近的健康组织。在“跟随”阶段，放射性药物成像可以监测治疗效果，确保剩余癌细胞被识别和处理。Clarivate医疗保健研究和数据分析师Suchitra Ghoshal说：“许多放射性药物可以使用核医学技术进行成像，从而实现对治疗的精确靶向和监测。” 这种完整的治疗和监测周期，使放射性药物成为精准肿瘤学的有效和通用方法。最近，在投资和创新方面，该领域都在加速发展。 Ghoshal分享了她认为需要改进的关键领域： • 下一代放射性示踪剂放射性示踪剂是一种先进的放射性化合物，用于PET和SPECT等成像技术，以可视化体内的生物过程。这些示踪剂通常针对与疾病（尤其是癌症）相关的特定生物标志物或代谢通路。市售放射性示踪剂的例子包括氟代脱氧葡萄糖（FDG）等。 • 诊疗学将诊断和治疗能力结合在一起的诊疗放射性药物的发展增强了核医学个性化治疗方法。Ghoshal强调，诊疗市场正在经历显著增长，特别是在各种癌症的治疗方面，包括前列腺癌、神经内分泌肿瘤和淋巴瘤。研究人员也正在研究将纳米技术整合到诊疗放射性药物中，使用各种纳米载体，如脂质体和树枝状聚合物，以改善放射性核素的递送和靶向。 • 靶向放射性药物（TRPs） TRPs用于将放射性同位素特异性地递送到表达特定生物标志物的癌细胞或组织。这些药物由靶向分子、连接剂、螯合剂和放射性核素组成，可以精确靶向肿瘤细胞，类似于抗体-药物偶联物，旨在取代传统化疗。主要目标是最大限度地提高治疗效果，同时最大限度地减少对周围健康组织的损伤。TRPs正逐渐用于神经退行性疾病的诊断。 • 放射性药物领域的AI Ghostal强调了AI对该领域做出特别贡献的一种方法——计算机分子设计。“AI通过计算机模拟方法增强了放射性药物的设计和验证。这些方法利用计算模型来预测化合物的行为，包括它们的结合性质和药代动力学（吸收、分布、代谢、排泄和毒性）。这种预测能力使开发过程更快、成本更低，减少了对传统体外和体内测试的依赖。AI的融合有望大幅扩大核医学的能力。” 2 待克服的挑战 Ghoshal指出，供应链管理是核医学面临的重大挑战。事实上，对于高效生产和分销放射性药物来说，特别是半衰期短的药物，维持可靠的供应链至关重要。这一领域还需要专门的基础设施和目前缺乏的专业工作人员。Ghoshal表示：“训练有素的核医学医生数量有限，而且我们需要多学科专业知识来有效管理放射性药物，这阻碍了放射性药物的广泛应用。” 开发和生产的高成本从长远来看，可能会限制放射性药物的可及性。除了技术挑战之外，监管也是需要解决的问题。 “由于放射性药物的独特性，包括其放射性和辐射安全要求，我们有必要建立专门的监管框架。放射性药物需要广泛的非临床和临床研究以确保其安全性和有效性。”Ghoshal补充道。这些研究除了非临床药理学、辐射暴露和影响以及影像学研究外，还包括确保人员安全参与生产和质量控制，以及在诊断过程中最大限度地减少对患者的辐射暴露，并最大限度地发挥治疗效果，同时最大限度地减少对健康组织的伤害。因此，高速发展的放射性药物行业面临的挑战也确实阻碍了该领域的投资、合作和并购。 3 “重磅”放射性药物交易目前放射性制药市场非常火爆，几笔交易对该领域产生了重大影响，其中包括Bracco Imaging和Blue Earth Diagnostics的收购案。该笔收购扩大了Bracco Imaging在精准医疗和个性化诊断方面的投资组合。Blue Earth Diagnostics带来了新型PET显像剂，如Axumin（fluciclovine F 18），可用于疑似复发性前列腺癌患者的PET显像。此外，Lantheus从Life Molecular Imaging获得了177Lu-DOTA-RM2和68Ga-DOTA-RM2的权益，使Lantheus的产品组合除了可用于治疗前列腺癌外，还增加了乳腺癌的适应症。这不仅加强了Lantheus在市场上的地位，也为患者提供了更广泛的治疗选择。去年10月，GE医疗与SOFIE生物科学公司达成的协议，有望对放射性药物领域产生重要影响。根据合作协议，GE医疗将商业化和生产SOFIE生物科学公司的两种用于癌症成像应用的试验性成纤维细胞激活蛋白抑制剂（FAPI）PET显像剂。 FAP是一种在癌症相关成纤维细胞（CAF）中高度表达的酶，CAF是肿瘤微环境的关键组成部分，支持癌细胞的生长和扩散。由于CAF存在于大多数肿瘤类型中，包括乳腺、胰腺、结肠、肺、肝和胃，因此FAP靶向诊断在肿瘤以及其他疾病（包括炎症、纤维化和关节炎）中具有巨大的潜力。这些PET放射性示踪剂目前正在美国进行II期临床试验。 4 哪些放射性药物值得留意？过去的几年里，FDA已在该领域批准了多项产品。比如，Lantheus针对癌症的靶向PET显像剂PYLARIFY于2021年获批，用于基于血清前列腺特异性抗原（PSA）水平升高的疑似前列腺癌症转移患者和疑似复发患者。 2023年，Blue Earth Diagnostics用于识别PSMA阳性病变和用于检测前列腺癌复发的高灵敏度的POSLUMA获得批准。同年，Telix Pharmaceuticals的Illucix也被批准用于选择转移性去势抵抗性前列腺癌患者，适合接受靶向PSMA放射性配体疗法Pluvicto治疗者。 Ghoshal表示，放射性药物领域的大多数临床试验都集中在PSMA和FAPI靶点上。以下是一些值得关注的试验：此外，Lantheus在肿瘤学方面还拥有几个值得关注的候选产品：PNT2002在SPLASH试验中已显示出积极的顶线结果，预计今年还会披露更多数据；治疗阿尔茨海默病的晚期β淀粉样蛋白PET显像剂NAV-4694目前处于III期开发阶段。被阿斯利康收购的Fusion Pharmaceuticals也是该领域的参与者，其用于转移性去势抵抗性前列腺癌患者的FPI-2265疗法正处于II/III期临床阶段。FPI-2059是另一项处于I期临床的候选产品。这是一种NTSR1靶向α疗法，使用actinium-225，旨在治疗多种类型的实体瘤，包括胃肠道和胰腺癌。 5 放射性制药投资前景大型制药公司正在积极收购放射性药物初创公司，增强他们在这一领域的能力。 2024年5月，诺华宣布收购Mariana Oncology。此次收购涵盖了一个强大的RLT项目组合，涉及一系列实体瘤适应症（如乳腺癌、前列腺癌和肺癌），包括针对小细胞肺癌的基于锕的先导RLT项目MC-339。不少公司也选择建立战略伙伴关系，开发新型放射性药物。一个主要的例子是Eckert & Ziegler和Alpha-9 Theranostics之间的合作，以确保actinium-225的供应，这是下一代靶向放射性核素疗法的关键组成部分。 Lantheus首席执行官认为，未来几年将会出现一波新一代放射性药物，改善靶向制剂、螯合剂、安全持有放射性同位素的分子，确保同位素安全地运输到体内的目标部位，以及调整治疗指数的同位素。毫无疑问，核医学将在未来不断发展，并为市场带来更多新的治疗方案，从癌症开始，拓展至神经退行性疾病等更多其他疾病。国内众多中国医药公司也已进军核医学领域，越来越多的资本投向这一赛道。面对相对蓝海的核药产业，如何把握机遇，用好上下游资源，避免内卷，成就高质量的创新，实现临床疗效与商业价值的双赢？ 10月24-26日，同写意将携手烟台生物医药健康产业发展集团，邀请核药领域领军人物去往烟台，在蓝色药谷生命岛深度探讨中国核药产业创新的未来。活动的第一天，中国科学院上海药物研究所分子影像中心主任、美国医学与生物工程院会士程震，东诚药业副总经理、蓝纳成生物总经理吴晓明，中信证券医药分析师袁聪敏，埃格林医药联合创始人兼CMO李长青等嘉宾，将针对核药行业现在和未来趋势进行现场分享，共寻企业合作发展大计。会议日程 2024年10月24日 09:00-12:00　注册签到 12:00-13:00　写意午宴 14:00-15:00　参观学习 15:00-15:05　开场发言 15:05-15:20　领导致辞 15:20-15:35　园区推介 15:35-16:00　科学家说中国放射性药物研究现状程　震：中国科学院上海药物研究所分子影像中心主任，美国医学与生物工程院会士 16:00-16:20　企业家说放射性药物产业发展实践及创新机遇吴晓明：东诚药业副总经理，蓝纳成生物总经理 16:20-16:40　投资者说百亿蓝海与投资方向，BD全球进展，未来趋势分析袁聪敏：中信证券医药分析师 16:40-17:00　“核”以出海？核药的全球化开发李长青：埃格林医药联合创始人兼CMO 17:00-17:10　茶歇☕ 17:10-18:00　圆桌对话中国核药向何处去 ▶　核药原始创新-放射性药物靶点多样化趋势；火爆的市场与BD交易须　涛（主持）：智核生物CEO，同写意核药俱乐部秘书长 ▶　核药全产业链开发与合作-同位素、供应链、CMC、安全评价、临床需求喻峰（主持）：亦立医药创始人、CEO 18:30-20:00　写意晚宴 2024年10月25日参观考察交流（本次活动定向邀约）参考文章： The radiopharmaceutical revolution：From diagnosis to treatment, oncology and beyond；labiotech 同写意媒体矩阵，欢迎关注↓↓↓

放射疗法并购抗体药物偶联物

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