The purpose of this study is to investigate the usefulness of PET/MRI with an investigational radioactive drug, 18F-rhPSMA-7.3, and MRI contrast in evaluating patients with prostate cancer eligible for active surveillance. This study is for imaging purposes only and is not a treatment study.

开始日期2025-04-30

申办/合作机构

The University of Alabama at Birmingham

NCT06580015

/ RecruitingN/AIIT

Posluma (18F-rhPSMA) PET Guided Radiotherapy Planning in Prostate Cancer: A Prospective Study Evaluating POSLUMA PET Tumor Detection on Radiation Therapy Planning and on BGRT Planning on the RefleXion X1 System

This clinical trial evaluates [18F]-rh PSMA positron emission tomography (PET)-computed tomography (CT) imaging performance in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA. Because some cancers take up [18F]-rhPSMA, cancer cells can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Posluma (18F-rhPSMA) is an approved prostate-specific membrane antigen (PSMA) imaging agent for prostate cancer. The RefleXion Medical Radiotherapy System (RMRS) is designed to facilitate delivery of biology-guided radiotherapy (BgRT). The system uses PET emissions to guide radiotherapy delivery in real-time and has been studied for use with fludeoxyglucose (FDG) (which is an agent used in standard PET-CT scans that targets glucose). Information gathered from this study may help researchers to improve PET-CT imaging on the RefleXion system. This information will be used in the future to improve planning and delivery of radiation therapy that will target (in real time) the signal released from the [18F]-rhPSMA PET-CT tracer. Comparing the imaging from the standard of care [18F]-rh PSMA PET-CT with the imaging from RMRS may help improve the quality of the imaging captured on the RMRS for detection of imaging signals in patients with prostate cancer.

开始日期2025-02-24

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06813898

/ Not yet recruiting早期临床1期IIT

ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging

This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography [PET]/computed tomography [CT]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET/CT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET/CT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.

开始日期2025-02-17

申办/合作机构

Northwestern University

[+1]

100 项与氟[18F]妥司特相关的临床结果

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100 项与氟[18F]妥司特相关的转化医学

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100 项与氟[18F]妥司特相关的专利（医药）

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项与氟[18F]妥司特相关的文献（医药）

2024-08-01·Advances in Radiation Oncology

Impact of Clinical Factors on 18F-Flotufolastat Detection Rates in Men With Recurrent Prostate Cancer: Exploratory Analysis of the Phase 3 SPOTLIGHT Study

Article

作者: Davis, Phillip ; Uchio, Edward M ; Lowentritt, Benjamin H ; Chau, Albert ; Helfand, Brian T ; Schuster, David M ; Morris, Michael A ; Michalski, Jeff M ; Chapin, Brian F ; Jani, Ashesh B

Purpose:

¹⁸F-Flotufolastat (¹⁸F-rhPSMA-7.3) is a newly approved prostate-specific membrane antigen targeting radiopharmaceutical for diagnostic imaging of prostate cancer (PCa). SPOTLIGHT (National Clinical Trials 04186845) evaluated ¹⁸F-flotufolastat in men with suspected PCa recurrence. Here, we present results of predefined exploratory endpoints from SPOTLIGHT to evaluate the impact of clinical factors on ¹⁸F-flotufolastat detection rates (DR).

Methods and Materials:

The impact of baseline prostate-specific antigen (PSA), PSA doubling time (PSAdt), and International Society of Urologic Pathology Grade Group (GG) on ¹⁸F-flotufolastat DR was evaluated among all SPOTLIGHT patients with an evaluable scan, with DR stratified according to the patients' prior treatment (radical prostatectomy ± radiation therapy [RP] or radiation therapy only [RT]). The patients underwent positron emission tomography 50 to 70 minutes after receiving ¹⁸F-flotufolastat (296 MBq IV), and scans were read by 3 blinded central readers, with the majority read representing agreement between ≥2 readers.

Results:

In total, 389 men (median PSA: 1.10 ng/mL) were evaluable. By majority read, ¹⁸F-flotufolastat identified distant lesions in 39% and 43% of patients treated with prior RP or RT, respectively. The overall DR broadly increased with increasing PSA (<0.2 ng/mL: 33%; ≥10 ng/mL: 100%). Among patients with PSA <1 ng/mL, 68% had positive scans, and 27% had extrapelvic findings. PSAdt was available for 145/389 (37%) patients. PSAdt did not appear to influence ¹⁸F-flotufolastat DR (77%-90% across all PSAdt categories). Among patients with prior RP, DR ranged from 70% to 83% across PSAdt categories, and 100% DR was reported for all post-RT patients. In total, 362/389 (93%) patients had baseline GG data. Overall DRs were uniformly high (75%‒95%) across all GG. When stratified by prior treatment, DRs across all GG were 69% to 89% in patients with prior RP and ≥96% in patients with prior RT.

Conclusions:

¹⁸F-Flotufolastat-positron emission tomography enabled the accurate detection of recurrent PCa lesions across a wide range of PSA, PSAdt, and International Society of Urologic Pathology GG, thus supporting its clinical utility for a broad range of patients with recurrent PCa.

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

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

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.

项与氟[18F]妥司特相关的新闻（医药）

2024-11-04

·Business Wire

Blue Earth Diagnostics, a Bracco Company, Applauds New CMS Rule to Support Patient Access Through Improved Payment for Specialized Diagnostic Radiopharmaceuticals

MONROE TOWNSHIP, N.J., & OXFORD, England--( BUSINESS WIRE )--Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, welcomes changes announced by the Centers for Medicare & Medicaid Services (CMS) for the Hospital Outpatient Prospective Payment System (OPPS) Rule on November 1, 2024. The rule, which goes into effect January 1, 2025, is designed to improve payments for diagnostic radiopharmaceuticals for U.S. Medicare patients, and has the potential to increase sustained access to innovative radiopharmaceuticals. “ We are very pleased that CMS has updated this rule, which will increase patient access to advanced diagnostic imaging products to inform patient management and treatment,” said Marco Campione, Chief Executive Officer of Blue Earth Diagnostics. “ This action will foster additional innovation and sustainability in nuclear medicine and molecular imaging, aligning with our company commitment to deliver leading-edge radiopharmaceutical solutions for improved patient care.” “ Since its inception, Blue Earth Diagnostics has championed the need for reimbursement reform around CMS payment methodology for diagnostic radiopharmaceuticals. This rule corrects a significant reimbursement gap that previously hampered the adoption of innovative radiopharmaceutical products, and patient access,” said Terri Wilson, President, Blue Earth Diagnostics. “ It supports Blue Earth Diagnostics’ entire portfolio of diagnostic imaging agents. POSLUMA ® (flotufolastat F 18) maintains its current Pass-Through payment status until September 30, 2026. Axumin ® (fluciclovine F 18), which previously lost Pass-Through status in January 2020, will regain separate payment under this new rule. Although the updated payment methodology provides for separate payment for diagnostic radiopharmaceuticals, payment will differ for Pass-Through and non-Pass-Through diagnostic radiopharmaceuticals. Our field reimbursement team continues to work with hospitals to ensure they understand the new rule and its implications.” Indication and Important Safety Information About Axumin INDICATION Axumin ® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended. Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available. Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers. Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia. To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf . Indication and Important Safety Information About POSLUMA INDICATION POSLUMA ® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf . About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com . 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: www.braccoimaging.com . PP-rh-US-0581 This press release is for U.S. audiences only

放射疗法诊断试剂并购

2024-11-04

·Insight数据库

25 家制药公司完成新一轮融资

Insight 投融资数据库显示，上周全球制药领域发生 25 起投融资事件（截至 11 月 1 日）：从药物类型来看，小分子之外，单抗，抗体偶联药物（ADC）、细胞和基因疗法（CGT）、放射性药物、反义寡核苷酸（ASO）等新分子也备受资本看好；从地区分布来看，上周获得融资的 Biotech 仍然主要来自美国，占比达到约 48%；在中国，华昊中天、柯君医药、恒敬合创、赛蕴生物等多家公司完成新一轮融资；从金额来看，眼科疗法研发公司 EyePoint 融资金额最高，融资金额达 1.4 亿美元。下面，Insight 数据库将节选部分备受关注的融资案例做介绍，仅供读者参阅。中国新锐融资华昊中天在港挂牌上市华昊中天在港交所上市，发行价为 16 港元/股，此次发售 1458.8 万股，募资总额为 2.33 亿港元（约 2 亿元）。华昊中天是一家合成生物学技术驱动的生物医药公司，致力于开发肿瘤创新药。华昊中天的产品研发管线涵盖 1 款已商业化的产品和 19 款在研项⽬。其中，新一代微管抑制剂优替德隆注射液（商品名：优替帝）已于 2021 年 3 月在中国获批上市，用于晚期和转移性乳腺癌的治疗。恒敬生物获超 2 亿元 A 轮/A+轮融资恒敬生物完成合计约 2.5 亿元 A 轮和 A+轮融资，投资者包括上海张科领弋和老股东，也有创始团队自筹资金。本次融资主要用于该公司在研产品的临床研究、生产项目建设、日常运营等。恒敬生物由范豪博士创办于 2021 年，专注于从事以胰岛素和 GLP-1 受体激动剂为代表的生物类似药、生物创新药、生物制品的产业化。目前，该公司已搭建起一套原核细胞基因工程生产重组蛋白的技术平台，并开展了从原料药到 CDMO 服务、产品研发和生产的全产业链布局。赛蕴生物完成天使轮融资赛蕴生物宣布完成由生命园创投基金与知名基金联合领投的数千万元天使轮融资，其他投资人还有英诺天使基金等。本轮融资将为赛蕴生物的发展提供支持，同时通过与国内科研机构和医院的合作，该公司有望在新型递送载体开发、管线推进等方面取得更多进展。赛蕴生物致力于开发蛋白和核酸靶向的递送载体技术及相关药物创新疗法。该公司研发的天然递送系统可经过理性改造，将功能性生物大分子等各种类型的有效载荷直接递送至特定细胞中，具有细胞识别的高特异性、对载荷的高兼容性和保护性及生产成本低等优势。柯君医药完成 B+轮阶段性融资柯君医药宣布完成由国信创新股权领投的 B+轮阶段性融资，其他投资人还有谊安集团、英飞尼迪资本、宏海资本等。本次融资将用于加速推进该公司心脑血管领域核心产品 CG-0255 的临床开发进程。柯君医药成立于 2018 年，专注于小分子及核酸药物研发。CG-0255 是其自主研发的新一代抗血小板药物，属于 P2Y12 受体拮抗剂，目前正在美国推进注册临床工作。另外，柯君医药在抗病毒领域也布局了抗广谱呼吸道抗病毒药物、慢性乙肝功能性治愈等多个管线。海外新锐融资 EyePoint 完成 1.4 亿美元融资 EyePoint Pharmaceuticals 宣布以每股 11.00 美元的公开发行价格承销其 1272 多万股普通股，此次发售的总收益预计约为 1.4 亿美元。本次融资主要用于推进该公司 Duravyu 治疗湿性年龄相关性黄斑变性（湿性 AMD）和糖尿病性黄斑水肿（DME）的药物临床开发，并支持其早期管线开发计划等。 EyePoint 致力于开发和商业化创新疗法，以改善严重视网膜疾病患者生活，其专有的生物可再生 Durasert E 技术可用于持续的眼内药物输送。该公司的主要候选产品 Duravyu 是一种针对 VEGF 介导的视网膜疾病的持续递送治疗方法，目前正在进行全球关键 Ⅲ 期临床试验。 Axonis 完成 1.15 亿美元 A 轮融资 Axonis Therapeutics 宣布完成由 Cormorant Asset Management 和 venBio Partners 共同领投的 1.15 亿美元 A 轮融资，其他投资人还有 Sofinnova investments、MRL Ventures Fund、Perceptive Advisors、Lumira Ventures 和 Solasta Ventures 等。 Axonis 公司专注于开发新型神经药物。本轮融资将用于推进该公司主要候选药物 AXN-027 的临床概念验证，以及新一代靶向 KCC2 化合物的开发。AXN-027 是一种潜在「first-in-class」的口服小分子药物，拟开发适应症包括癫痫和疼痛。本轮融资还将支持其新一代靶向 KCC2 化合物的开发，覆盖癫痫、疼痛、精神类和神经发育类疾病等适应症。 Evommune 完成 1.15 亿美元 C 轮融资 Evommune 公司宣布完成由 RA Capital Management 和 Sectoral Asset Management 共同领投的 1.15 亿美元 C 轮融资，其他投资人还有 B Capital、Marshall Wace、Avego Bioscience Capital、Longwood Fund、RTW Investments 等。本次融资将用于支持 Evommune 公司 MRGPRX2 抑制剂 EVO756 及 IL-18 靶向融合蛋白疗法 EVO301 的临床开发。其中，EVO756 是一种口服、强效、高选择性的 MRGPRX2 小分子拮抗剂，EVO301 是一种长效、与血清白蛋白结合的融合蛋白注射疗法。该公司预计于 2025 年和 2026 年公布这些疗法在慢性荨麻疹和特应性皮炎患者中的多个 Ⅱ 期试验数据。 Kivu 完成 9200 万美元 A 轮融资 Kivu Bioscience 宣布完成由 Novo Holdings 领投的 9200 万美元 A 轮融资，其他投资人还有 Gimv、Red Tree Venture Capital、HealthCap、BioGeneration Ventures 等。本次融资将用于推进 Kivu 公司多个肿瘤学项目进入临床阶段。 Kivu 公司专注于使用其专有的 Synaffix 位点特异性连接载荷技术来开发下一代 ADC 疗法，该技术可以显著提高 ADC 的稳定性，减少潜在副作用。目前，Kivu 公司的研发项目处于临床前研究后期，其中主导候选药物有望于 2025 年启动 Ⅰ 期临床试验。 Blue Earth 完成 7650 万美元 A 轮融资 Blue Earth Therapeutics 宣布完成由 Soleus Capital 和 Sands Capital Management 领投的 7650 万美元 A 轮融资，其他投资人还有 Bracco Imaging SpA、Woodline Partners 和 PBM Capital。本轮融资将帮助该公司进一步推进其临床阶段的前列腺特异性膜抗原（PSMA）靶向放射性配体疗法的开发。 Blue Earth 致力于开发治疗性放射性药物，用于治疗癌症患者。目前，该公司已建立系列产品管线，包括两款 rhPSMA 分子，一个使用发射β射线的放射性同位素镥 177（177Lu），另一个使用发射α射线的锕 225（225Ac）。其中，基于 177Lu 的放射性配体疗法已经进入 Ⅰ 期临床试验，用于治疗前列腺癌患者。 Pathos AI 完成 6200 万美元 C 轮融资 Pathos AI 宣布完成由 New Enterprise Associates（NEA）牵头的 6200 万美元 C 轮融资，其他投资人还有 Revolution Growth 等。本轮融资将使 Pathos AI 能够扩大其科学家和工程师团队，加速其人工智能药物开发平台的开发，并推进其精准肿瘤治疗的临床阶段管线。 Pathos AI 专注于通过人工智能重新设计药物开发，曾在过去一年内收购了两项临床阶段精准肿瘤学资产，如脑渗透性 PRMT5 抑制剂 P-500，并计划在 2025 年启动下一项临床试验。 Leal Therapeutics 完成 4500 万美元融资 Leal Therapeutics 宣布完成由 Newpath Partners 领投的 4500 万美元融资，其他投资人还有 Orbidden、Euclidean Capital、PhiFund、Chugai Venture Fund 和 Alexandria Venture Investments。本轮融资将用于推进该公司针对中枢神经系统（CNS）疾病的反义寡核苷酸（ASO）和小分子疗法产品管线。 Leal Therapeutics 是一家为 CNS 疾病患者开发新型疗法的生物技术公司。其主要在研项目包括治疗肌萎缩侧索硬化（ALS）的 ASO 疗法 LTX-002，以及针对精神分裂症患者的小分子药物 LTX-001。该公司计划在 2024 年底前提交 LTX-002 和 LTX-001 的 IND 申请，并在 2025 年初启动首次人体临床试验。 Eupraxia 完成 4450 万加元融资 Eupraxia Pharmaceuticals 宣布已完成一笔 4450 万加元的私募融资，融资所得将用于资助其在研产品 EP104 GI 的临床试验，以及为新候选药启动研究计划等。 Eupraxia 是一家临床阶段生物技术公司，正利用其专有的 DiffuSphere 技术优化药物输送，以解决医疗需求未得到满足的治疗领域。EP-104 GI 是一款嗜酸性食管炎潜在疗法，采用食管壁注射给药方式，目前正在进行 Ⅰb/Ⅱa 期试验。 Celaid 完成 1.4 亿日元融资 Celaid Therapeutics 宣布已从 KUC1 Investment Limited Partnership 和 Techno Science 获得总计 1.4 亿日元资金支持。此外，该公司还收到现有投资者 Techno Science 的进一步投资，使其 A 轮融资总额达到 11 亿日元（不包括赠款）。本次融资预计将进一步加快 Celaid 公司的管线开发和平台业务活动。 Celaid 是一家造血干细胞（HSC）初创公司，拥有选择性体外 HSC 扩增的专有技术，旨在提供下一代细胞和基因治疗产品，用于血液病的细胞治疗、遗传疾病的离体 HSC 基因治疗以及缺血性疾病的血管生成等。除了上述案例，上周还有一些其它公司也获得了融资，限于篇幅，此处不再一一介绍。欲了解上周更多融资信息，请点击「阅读原文」前往 Insight 数据库「新药投融资」模块查看。封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

上市批准生物类似药抗体药物偶联物细胞疗法基因疗法

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

100 项与氟[18F]妥司特相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
前列腺癌	美国	Blue Earth Diagnostics Ltd.初创企业	2023-05-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
前列腺腺癌	临床2期	美国	Blue Earth Diagnostics Ltd.初创企业	2023-04-27
非转移性前列腺癌	临床2期	美国	Blue Earth Diagnostics Ltd.初创企业	2023-04-27
复发性前列腺癌	临床2期	美国	Blue Earth Diagnostics Ltd.初创企业	2023-04-27

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临床结果

适应症

分期

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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


NCT04186845 (SPOTLIGHT, Biospace) 人工标引	临床3期	复发性前列腺癌 Prostate specific antigen	119	POSLUMA (PSA < 1 ng/mL)	積簾襯壓遞網範憲淵獵(憲鑰繭夢範願蓋醖鹽積) = 遞繭廠膚鹹醖觸顧夢鏇蓋選製醖廠鹽製衊築壓 (膚窪願艱積襯淵築齋選 )	积极	2024-10-01
				POSLUMA (PSA< 0.5 ng/mL)	積簾襯壓遞網範憲淵獵(憲鑰繭夢範願蓋醖鹽積) = 繭顧鬱繭壓顧鹹觸壓夢蓋選製醖廠鹽製衊築壓 (膚窪願艱積襯淵築齋選 )
ASTRO2024	N/A	非转移性前列腺癌	-	F-18 rhPSMA 7.3 PET/MRI	醖憲築餘廠範餘醖窪製(繭齋鏇壓淵淵憲憲衊醖) = 鬱膚壓衊艱簾積製廠艱願廠衊鏇醖淵壓遞夢積 (壓範鹽製繭鑰構積積簾 ) 更多	-	2024-10-01
NCT04186819 \| NCT04186845 (SPOTLIGHT, Literature) 人工标引	临床3期	前列腺癌	712	POSLUMA	鹽範襯鹽鬱夢壓蓋繭蓋(網範積鏇鹹積網構築糧) = 網糧淵鏇繭壓範鑰糧簾製夢積簾選繭餘顧夢糧 (醖網壓衊鹹衊鬱鹽願鬱 ) 更多	积极	2023-11-06
NCT04186819 (LIGHTHOUSE, ASTRO2023)	临床3期	前列腺癌 PSMA	197	18F-rhPSMA-7.3 PET	願網網夢遞鹹壓醖製淵(鑰鏇衊淵範夢繭廠獵糧) = 鬱鬱鑰艱壓積鏇簾憲願網選衊淵醖襯網構鏇鹹 (獵鹹繭衊顧遞襯窪選簾 ) 更多	积极	2023-10-01
SNMMI2023	N/A	前列腺癌	-	18F-rhPSMA-7.3 (Fasting)	簾壓願鹽膚夢選膚繭築(蓋觸選網範網網窪鬱選) = 醖製艱壓憲夢鹹衊鏇製觸遞憲艱獵壓憲範簾艱 (膚餘齋鏇鹽鏇餘鏇糧構 )	-	2023-08-28
				18F-rhPSMA-7.3 (Non-fasting)	簾壓願鹽膚夢選膚繭築(蓋觸選網範網網窪鬱選) = 製築選鬱窪廠壓選遞鹹觸遞憲艱獵壓憲範簾艱 (膚餘齋鏇鹽鏇餘鏇糧構 )
SNMMI2023	N/A	-	-	18F-rhPSMA -7.368Ga-PSMAA -7.3 (68Ga-PSMA PET-based nomogram)	繭範鑰選繭網蓋壓鑰膚(齋壓淵蓋糧淵窪鏇願窪) = 8.8 months (95%CI 7.7-9.9) 壓選鬱衊鹽糧餘鏇衊糧 (齋餘繭鏇齋顧醖醖蓋壓 ) 更多	-	2023-08-28
				18F-rhPSMA -7.318F-rhPSMA-7.33 (18F-rhPSMA-7.3 PET)
NCT04186819 (LIGHTHOUSE, ASCO_GU2023) 人工标引	临床3期	前列腺癌	335	18F-rhPSMA-7.3	艱襯鹹窪蓋膚窪糧淵鏇(積遞獵衊艱獵蓋廠鏇鑰) = 網廠鹽鹹積壓顧醖願鏇願遞鏇淵艱築繭製選鏇 (積簾獵鬱醖願窪蓋窪蓋, 4.2 ~ 9.8) 更多	积极	2023-02-21
NCT04186845 (SPOTLIGHT Study, EANM2022)	临床3期	复发性前列腺癌	366	18 F-rhPSMA-7.3 PET	獵繭網艱鬱艱淵簾願觸(醖觸餘夢襯顧衊網遞糧) = 製夢積網醖窪鑰製糧糧鑰構艱齋憲窪積襯觸醖 (膚壓簾衊遞窪鬱壓淵醖, 12.9 ~ 23.9)	积极	2022-09-22
NCT04186845 (SPOTLIGHT, ASCO_GU2022) 人工标引	临床3期	前列腺癌 PSA	389	18 F-rhPSMA-7.3	簾簾範願鑰齋鹹遞鏇夢(獵廠膚鬱簾鬱鹹網衊製) = 襯餘鏇夢艱襯憲觸獵鹹艱繭簾觸窪鏇糧遞繭願 (觸鹹醖鑰窪襯選齋齋齋, 51.6 ~ 62.0) 更多	积极	2022-02-16
				18 F-rhPSMA-7.3 (patients with a histopathology-only SoT)	簾簾範願鑰齋鹹遞鏇夢(獵廠膚鬱簾鬱鹹網衊製) = 襯鹽觸壓襯鹹鏇壓顧鹽艱繭簾觸窪鏇糧遞繭願 (觸鹹醖鑰窪襯選齋齋齋, 69.9 ~ 89.6) 更多
SNMMI2020	N/A	前列腺癌	-	F-18-rhPSMA-7.3 PET imaging	製憲獵網壓願憲餘網淵(膚蓋淵範鹽築窪鹽範鹹) = 築憲艱艱廠襯醖糧製簾範壓鹹積衊鏇蓋觸顧糧 (願鹽鹹網窪襯廠糧襯顧 ) 更多	-	2020-05-15
				F-18-rhPSMA-7.3 (Morphological imaging)	製憲獵網壓願憲餘網淵(膚蓋淵範鹽築窪鹽範鹹) = 鹹廠齋夢鬱齋艱選鬱鹽範壓鹹積衊鏇蓋觸顧糧 (願鹽鹹網窪襯廠糧襯顧 ) 更多