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.

Start Date30 Apr 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT06580015

/ RecruitingNot ApplicableIIT

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.

Start Date24 Feb 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06813898

/ RecruitingEarly Phase 1IIT

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.

Start Date17 Feb 2025

Sponsor / Collaborator

Northwestern University

[+1]

100 Clinical Results associated with Flotufolastat F-18

100 Translational Medicine associated with Flotufolastat F-18

100 Patents (Medical) associated with Flotufolastat F-18

Literatures (Medical) associated with Flotufolastat F-18

01 Aug 2024·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

Author: Uchio, Edward M ; Davis, Phillip ; 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.

01 Aug 2024·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

Author: Esposito, Giuseppe ; Chau, Albert ; Zukotynski, Katherine ; Chapin, Brian F ; Miller, Matthew P ; Penny, Ross ; Ulaner, Gary A ; Yoo, Don ; 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.

01 Jul 2024·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

Author: Davis, Phillip ; Chapin, Brian F ; Hermsen, Rick ; Schuster, David M ; 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.

News (Medical) associated with Flotufolastat F-18

05 Nov 2024

·synapse.patsnap.com

Global Pharmaceutical Industry Financing Transactions Weekly Report (10.28-11.3)

Pharmaceutical licensing collaboration1.Novartis Inks Over $2 Billion Deal On October 28th, Monte Rosa Therapeutics has announced a collaboration with Novartis, granting Novartis exclusive global rights to develop, manufacture, and commercialize MRT-6160 and other molecular glue protein degraders targeting VAV1. Under the agreement, Monte Rosa will receive $150 million upfront and is eligible for up to $2.1 billion in development, regulatory, and sales milestone payments. MRT-6160 is a potent, highly selective oral VAV1 degrader with potential as a treatment for immune-mediated diseases, including multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, and dermatological disorders. The compound is currently in a Phase I clinical trial in healthy volunteers. 2.AbbVie Acquires CNS Start-Up in $1.4 Billion Deal On October 28th, AbbVie and Aliada Therapeutics have reached a definitive agreement under which AbbVie will acquire Aliada for approximately $1.4 billion, gaining access to its lead Alzheimer's disease (AD) therapy, ALIA-1758. The acquisition is expected to close in Q4 2024. Aliada is focused on developing innovative treatments for central nervous system (CNS) diseases utilizing a novel blood-brain barrier (BBB) crossing technology. ALIA-1758, which uses this novel delivery technology to transport anti-3pE-Aβ antibodies across the BBB via TfR targeting, is currently in Phase I clinical trials. 3.Biogen Embarks on $1.45 Billion Molecular Glue Collaboration On October 29th, Biogen and Neomorph have announced a research collaboration aimed at discovering and developing molecular glue degraders for the treatment of Alzheimer’s disease and rare neurological and immune system disorders. Neomorph will receive up to $1.45 billion in upfront and milestone payments under the agreement. Neomorph specializes in developing molecular glue protein degraders for “undruggable targets,” and the partnership will leverage Neomorph’s proprietary platform to expedite the identification and validation of new small-molecule therapeutic molecular glue degraders. Biogen will oversee the clinical development and potential commercialization of the lead candidates. 4.GSK Acquires Chimagen T-Cell Engager (TCE) for $850 Million On October 29th, GlaxoSmithKline (GSK) has announced an acquisition of Chimagen’s T-cell engager (TCE) product CMG1A46, paying $300 million upfront for all global rights to the asset. Chimagen will be eligible for an additional $550 million in development and commercial milestone payments under the agreement. CMG1A46 is a TCE that targets both CD19 and CD20 with high affinity for B cells expressing these markers and low affinity for CD3. The product is currently in Phase I clinical trials for leukemia and lymphoma in the U.S. and China. GSK aims to further develop and commercialize CMG1A46, with a focus on autoimmune diseases driven by B cells. 5.AbbVie Enters $1.5 Billion Collaboration to Develop Novel Antibody Therapies On October 31st, AbbVie and EvolveImmune Therapeutics have announced a collaboration valued at approximately $1.5 billion to develop novel antibody therapies targeting solid tumors and hematologic malignancies using EvolveImmune’s T-cell engager (TCE) platform. Under the agreement, EvolveImmune will receive $65 million in upfront payments and equity investment, with potential milestone payments of up to $1.4 billion. EvolveImmune is dedicated to developing potential "first-in-class" multifunctional biologics to address immune deficits caused by cancer in solid and hematologic tumors. Its proprietary platform is designed to provide potent, selective, and integrative T-cell co-stimulation to enhance and sustain T-cell tumor-killing activity. 6.HK inno.N Introduces New Immunotherapy Recently, South Korean pharmaceutical company HK inno.N has announced an agreement with Novacell Technology to acquire a new immunotherapy candidate. This next-generation synthetic peptide acts as an FPR2 (formyl peptide receptor 2) agonist, enhancing the body's ability to control excessive immune responses. HK inno.N aims to leverage its anti-inflammatory and cell-regeneration properties to develop treatments for various inflammatory conditions, including ophthalmic, dermatological, and respiratory diseases. This partnership is expected to help expand its immunotherapy pipeline, addressing the growing need for immune therapies in aging populations with weakened immune functions. 7.GC Biopharma Partners with Novelty Noble for Joint Research Recently, GC Biopharma has entered a joint research agreement with Novelty Noble, a Korean biotech company specializing in antibody drug development, to develop treatments for geographic atrophy (GA). GA is an advanced form of dry age-related macular degeneration (AMD) that damages retinal tissue and can lead to blindness. Under this agreement, the two parties will collaborate through all stages of development, from identifying candidate antibody-based protein therapies to preclinical, clinical trials, and eventual commercialization. The initial phase will focus on identifying target proteins involved in GA pathology and developing candidate inhibitors, followed by proof-of-concept studies. Pharmaceutical Financing Events1.Kivu Completes $92 Million Series A Financing On October 28th, Kivu Bioscience announced the completion of a $92 million Series A financing led by Novo Holdings, with participation from Gimv, Red Tree Venture Capital, HealthCap, and BioGeneration Ventures. This funding will support Kivu’s transition of multiple oncology projects into clinical stages. Kivu is focused on developing next-generation ADC therapies using its proprietary Synaffix site-specific conjugation technology, which enhances ADC stability and reduces potential side effects. Kivu’s lead candidates are in the late preclinical research stage, with the primary candidate anticipated to enter Phase I clinical trials in 2025. 2.EyePoint Completes $140 Million Financing On October 29th, EyePoint Pharmaceuticals announced the successful underwriting of over 12.72 million shares of common stock at a public offering price of $11.00 per share, with total proceeds expected to reach approximately $140 million. The financing will primarily support the clinical development of the company’s drug, Duravyu, aimed at treating wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as its early-stage pipeline programs. EyePoint is dedicated to developing and commercializing innovative therapies to improve the lives of patients with serious retinal diseases. Its proprietary bio-renewable Durasert E technology facilitates sustained intraocular drug delivery. The company’s lead candidate, Duravyu, is a sustained-release treatment targeting VEGF-mediated retinal diseases and is currently undergoing a global pivotal Phase III trial. 3.Pathos AI Completes $62 Million Series C Financing On October 29th, Pathos AI announced the completion of a $62 million Series C financing led by New Enterprise Associates (NEA), with participation from Revolution Growth. The funds will allow Pathos AI to expand its team of scientists and engineers, accelerate the development of its AI-driven drug discovery platform, and advance its clinical-stage precision oncology pipeline. Pathos AI focuses on reshaping drug development through AI and has acquired two clinical-stage precision oncology assets in the past year, including the brain-penetrant PRMT5 inhibitor P-500, with plans to initiate the next clinical trial in 2025. 4.Axonis Completes $115 Million Series A Financing On October 30th, Axonis Therapeutics announced the completion of a $115 million Series A financing led by Cormorant Asset Management and venBio Partners, with participation from Sofinnova Investments, MRL Ventures Fund, Perceptive Advisors, Lumira Ventures, and Solasta Ventures. Axonis focuses on developing novel neurotherapeutics, with this funding set to advance its lead candidate, AXN-027, through clinical proof of concept and to develop next-generation KCC2-targeted compounds. AXN-027 is an oral small-molecule drug with potential as a first-in-class treatment for epilepsy and pain. This funding will also support the development of its next-generation KCC2-targeting compounds for indications such as epilepsy, pain, psychiatric, and neurodevelopmental disorders. 5.Blue Earth Completes $76.5 Million Series A Financing On October 30th, Blue Earth Therapeutics announced the completion of a $76.5 million Series A financing led by Soleus Capital and Sands Capital Management, with additional investors including Bracco Imaging SpA, Woodline Partners, and PBM Capital. This funding will advance the company’s clinical-stage development of a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy. Blue Earth is dedicated to developing therapeutic radiopharmaceuticals for cancer patients, with a pipeline including two rhPSMA molecules: one using the beta-emitting isotope lutetium-177 (177Lu) and the other using the alpha-emitting actinium-225 (225Ac). The 177Lu-based radioligand therapy is currently in a Phase I clinical trial for prostate cancer patients. 6.Hengjing Biotechnology Secures Over 200 Million RMB in Series A/A+ Financing On October 30th, Hengjing Biotechnology has successfully completed Series A and A+ financing rounds totaling approximately 250 million RMB. The funding will be used primarily for clinical research on its pipeline products, production project construction, and daily operations. Hengjing Biotechnology specializes in the industrialization of biologic drugs, focusing on biosimilars and innovative biologics like insulin and GLP-1 receptor agonists. The company has established a proprietary prokaryotic cell gene engineering platform for producing recombinant proteins and has implemented an end-to-end layout, from active pharmaceutical ingredient (API) development to contract development and manufacturing organization (CDMO) services, product development, and production. 7.CureGene Pharmaceutical Completes Series B+ Financing On October 31st, CureGene Pharmaceutical has announced the completion of its Series B+ financing led by Guoxin Innovation (China Bidding), with participation from aeonmed, INFINITY EQUITY MANAGEMENT COMPANY, and OCEANIC GROUP INVESTMENT LIMITED. This financing will accelerate the clinical development of CureGene’s core cardiovascular product, CG-0255. Founded in 2018, CureGene specializes in the development of small molecule and nucleic acid drugs. CG-0255, a new-generation antiplatelet drug targeting the P2Y12 receptor, is currently advancing through regulatory clinical trials in the United States. Additionally, CureGene has a pipeline that includes broad-spectrum antiviral drugs and treatments aimed at functional cures for chronic hepatitis B. 8.Leal Therapeutics Completes $45 Million Financing On October 31st, Leal Therapeutics announced the completion of a $45 million financing round led by Newpath Partners, with additional investment from Orbidden, Euclidean Capital, PhiFund, Chugai Venture Fund, and Alexandria Venture Investments. The funds will support the company’s development pipeline of antisense oligonucleotides (ASO) and small molecules for central nervous system (CNS) disorders. Leal Therapeutics is developing innovative therapies for CNS disorders, with key programs including LTX-002, an ASO therapy for amyotrophic lateral sclerosis (ALS), and LTX-001, a small molecule for schizophrenia patients. The company plans to submit IND applications for LTX-002 and LTX-001 by the end of 2024 and to initiate the first human trials in early 2025. 9.Eupraxia Completes CAD $44.5 Million Financing On October 31st, Eupraxia Pharmaceuticals announced the completion of a CAD $44.5 million private placement financing to support the clinical trials of its investigational product EP-104 GI and initiate research for new candidates. Eupraxia is a clinical-stage biotechnology company utilizing its proprietary DiffuSphere technology to optimize drug delivery for unmet medical needs. EP-104 GI, a potential treatment for eosinophilic esophagitis, is currently in a Phase Ib/IIa trial delivered via esophageal wall injection. 10.Evommune Completes $115 Million Series C Financing On November 1st, Evommune announced the successful completion of a $115 million Series C financing led by RA Capital Management and Sectoral Asset Management, with additional participation from B Capital, Marshall Wace, Avego Bioscience Capital, Longwood Fund, and RTW Investments. The funds will support the clinical development of Evommune’s MRGPRX2 inhibitor EVO756 and IL-18-targeted fusion protein therapy EVO301. EVO756 is an oral, potent, and highly selective MRGPRX2 small molecule antagonist, and EVO301 is a long-acting fusion protein injection therapy that binds to serum albumin. The company plans to release data from multiple Phase II trials for these therapies in chronic urticaria and atopic dermatitis patients by 2025 and 2026. 11.Celaid Completes JPY 140 Million Financing Recently, Celaid Therapeutics announced the receipt of JPY 140 million from KUC1 Investment Limited Partnership and Techno Science, with additional investment from existing investor Techno Science, bringing the total Series A funding to JPY 1.1 billion (excluding grants). The funding is expected to accelerate Celaid’s pipeline development and platform activities. Celaid is a hematopoietic stem cell (HSC) startup with proprietary technology for selective ex vivo HSC expansion, aiming to deliver next-generation cell and gene therapies for hematologic diseases, ex vivo HSC gene therapy for genetic disorders, and angiogenesis for ischemic conditions. For more information on the progress of pharmaceutical funding transactions, please consult the Synapse database.

04 Nov 2024

·www.businesswire.com

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

Radiation TherapyDiagnostic ReagentsAcquisition

30 Oct 2024

·www.prnewswire.com

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

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Indication	Country/Location	Organization	Date
Prostatic Cancer	US	Blue Earth Diagnostics Ltd.Startup	25 May 2023

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	US	Blue Earth Diagnostics Ltd.Startup	02 Mar 2020
Adenocarcinoma of prostate	Phase 3	FI	Blue Earth Diagnostics Ltd.Startup	02 Mar 2020
Adenocarcinoma of prostate	Phase 3	DE	Blue Earth Diagnostics Ltd.Startup	02 Mar 2020
Adenocarcinoma of prostate	Phase 3	NL	Blue Earth Diagnostics Ltd.Startup	02 Mar 2020
Non-metastatic prostate cancer	Phase 2	US	Blue Earth Diagnostics Ltd.Startup	27 Apr 2023
Recurrent Prostate Carcinoma	Phase 2	US	Blue Earth Diagnostics Ltd.Startup	27 Apr 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04186845 (SPOTLIGHT, Biospace) Manual	Phase 3	Recurrent Prostate Carcinoma Prostate specific antigen	119	POSLUMA (PSA < 1 ng/mL)	amuamvgeen(sqmwruccbe) = evtwglxtwr ewjxrcgahd (ydztjiyekf )	Positive	01 Oct 2024
				POSLUMA (PSA< 0.5 ng/mL)	amuamvgeen(sqmwruccbe) = ufgoaedatl ewjxrcgahd (ydztjiyekf )
ASTRO2024	Not Applicable	Non-metastatic prostate cancer	-	F-18 rhPSMA 7.3 PET/MRI	hjplyboecx(ymimxvgozc) = xmxshxajqh hwhbvttgtu (cjuvgmiqws ) View more	-	01 Oct 2024
NCT04186819 \| NCT04186845 (SPOTLIGHT, Literature) Manual	Phase 3	Prostatic Cancer	712	POSLUMA	ikbazcveim(qbyszxgalj) = ovjfmxrczf unkcwbbycq (ywuigbpatf ) View more	Positive	06 Nov 2023
NCT04186819 (LIGHTHOUSE, ASTRO2023)	Phase 3	Prostatic Cancer PSMA	197	18F-rhPSMA-7.3 PET	buabfrtqqb(aobmkcfgus) = ifnfwhwswv ltradznrvq (bidygdertk ) View more	Positive	01 Oct 2023
SNMMI2023	Not Applicable	-	-	18F-rhPSMA -7.368Ga-PSMAA -7.3 (68Ga-PSMA PET-based nomogram)	emdyxdsnsr(jqzncgraoh) = 8.8 months (95%CI 7.7-9.9) fqaysptris (dtefhildrk ) View more	-	28 Aug 2023
				18F-rhPSMA -7.318F-rhPSMA-7.33 (18F-rhPSMA-7.3 PET)
SNMMI2023	Not Applicable	Prostatic Cancer	-	18F-rhPSMA-7.3 (Fasting)	wulrersnxm(bkbuvoxwzi) = xpqpbgqjtk caqrsswmjj (sbmydoucjv )	-	28 Aug 2023
				18F-rhPSMA-7.3 (Non-fasting)	wulrersnxm(bkbuvoxwzi) = iguvgxcoxw caqrsswmjj (sbmydoucjv )
NCT04186819 (LIGHTHOUSE, ASCO_GU2023) Manual	Phase 3	Prostatic Cancer	335	18F-rhPSMA-7.3	husfsidnoz(jjdodqptcs) = adzmfvyxyz nzktkuhyxd (xxmwtkybom, 4.2 - 9.8) View more	Positive	21 Feb 2023
NCT04186845 (SPOTLIGHT Study, EANM2022)	Phase 3	Recurrent Prostate Carcinoma	366	18 F-rhPSMA-7.3 PET	swjlwplnbp(ivotsyjgfl) = csdwtxbwfm awurdukhmz (menkmqetzl, 12.9 - 23.9)	Positive	22 Sep 2022
NCT04186845 (SPOTLIGHT, ASCO_GU2022) Manual	Phase 3	Prostatic Cancer PSA	389	18 F-rhPSMA-7.3	edcwdzljvf(nkfxbjwtmf) = ijlnwdesen qvxdpqospx (yvtsuacccd, 51.6 - 62.0) View more	Positive	16 Feb 2022
				18 F-rhPSMA-7.3 (patients with a histopathology-only SoT)	edcwdzljvf(nkfxbjwtmf) = wjxtitzxow qvxdpqospx (yvtsuacccd, 69.9 - 89.6) View more
SNMMI2020	Not Applicable	Prostatic Cancer	-	F-18-rhPSMA-7.3 PET imaging	vagpqllhgj(dqjyydykgf) = jxnqqirkdp wjggphjgmf (yfhgdlvbxk ) View more	-	15 May 2020
				F-18-rhPSMA-7.3 (Morphological imaging)	vagpqllhgj(dqjyydykgf) = nmaopmhksb wjggphjgmf (yfhgdlvbxk ) View more

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