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Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)
Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)

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time2 days ago

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Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)

Lu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3 On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25 SYDNEY, July 28, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, 'Radiopharm' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has provided clearance of the Company's Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues. 'FDA clearance to initiate our first-in-human Phase 1 clinical trial of RV-01 represents a major milestone for Radiopharm Theranostics and our joint venture with MD Anderson Cancer Center,' said Riccardo Canevari, CEO and Managing Director. 'RV-01 is the first monoclonal antibody developed through this collaboration, and we believe it has the potential to become a highly differentiated radiopharmaceutical for patients with aggressive solid tumors. We are excited to advance this program into the clinic and anticipate dosing the first patients later this year.' 'Recent reported preclinical studies demonstrated that RV-01 exhibits hepatic clearance, allowing the isotope sufficient time to effectively target tumors while potentially minimizing adverse effects such as hematological toxicities. Unlike peptides or small molecules, monoclonal antibodies are primarily cleared by the liver—an organ known for its radio-resistance. This characteristic, combined with the shortened half-life of RV-01 and the strong affinity for the target make this agent stand out and may offer a significant advantage not just over other monoclonal antibodies but also targeted radiotherapeutics with renal excretion pathway, the latter of which are often associated with higher risk of radiopharmaceutical-induced kidney toxicity,' noted Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics. 'The high affinity and selectivity of RV-01 for the 4Ig isoform of B7H3 allows the antibody to bypass the soluble 2Ig isoform in the blood, boost binding of the radiopharmaceutical to tumor targets and avoid the formation of immune complexes in circulation,' noted David Piwnica-Worms, M.D., Ph.D., Professor, MD Anderson Cancer Center, and scientific co-founder of Radiopharm Ventures. B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types and has emerged as a compelling target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is consistently correlated with enhanced tumor aggressiveness and poor clinical outcomes. Targeting the 4 Ig isoform of B7-H3 with a selective radioligand therapy may offer a novel strategy for treating refractory or high-risk tumors. About RV-01 RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and MD Anderson Cancer Center (MDACC). RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent. RV-01 has received IND-clearance from the U.S. FDA and plans to initiate a first-In-human Phase 1 study in the second half of 2025. About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper. For more information: Investors:Riccardo CanevariCEO & Managing DirectorP: +1 862 309 0293E: rc@ Anne Marie FieldsPrecision AQ (formerly Stern IR)E: Media:Matt WrightNWR CommunicationsP: +61 451 896 420E: matt@ Follow Radiopharm Theranostics: Website – X – – –

Dr Oliver Sartor Appointed to Radiopharm Scientific Advisory Board
Dr Oliver Sartor Appointed to Radiopharm Scientific Advisory Board

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time22-07-2025

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Dr Oliver Sartor Appointed to Radiopharm Scientific Advisory Board

SYDNEY, July 22, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, 'Radiopharm' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce the appointment of Dr Oliver Sartor, MD to the Company's Scientific Advisory Board (SAB). Dr Sartor is an internationally recognised medical oncologist and scientist specialising in prostate cancer and radiopharmaceutical therapies. He currently serves as Director of Radiopharmaceutical Clinical Trials and Chair of the Genitourinary Cancer Disease Group at the world-renowned Mayo Clinic, in Rochester, Minnesota. He was previously Laborde Professor of Medicine and Urology and Medical Director of Tulane Cancer Center in New Orleans under Tulane University School of Medicine. Dr Sartor has also held senior roles at LSU Health Sciences Center, Dana‑Farber/Harvard Medical School, and as Medical Oncology Co‑Chair of the GU Committee of NRG Oncology. Dr Sartor received his MD with honours from Tulane University School of Medicine in 1982, completed internal medicine residency at Tulane, and a medical oncology fellowship at the National Cancer Institute (NCI). Since 1990 he has focused on prostate cancer clinical research, authoring more than 500 peer‑reviewed publications and leading multiple pivotal Phase 3 trials that resulted in FDA approvals for therapies including samarium‑153 EDTMP, cabazitaxel, radium‑223, and PSMA‑targeted radioligand therapy. 'Dr Sartor brings an unparalleled depth of expertise in both clinical translation and radiopharmaceutical therapies,' said Riccardo Canevari, Managing Director and CEO of Radiopharm Theranostics. 'We're very honoured to welcome him to our SAB. His insight and leadership will be invaluable as we advance our radiopharmaceutical pipeline.' About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper. For more information: Investors:Riccardo CanevariCEO & Managing DirectorP: +1 862 309 0293E: rc@ Anne Marie Fields Precision AQ (Formerly Stern IR) E: Media:Matt WrightNWR CommunicationsP: +61 451 896 420E: matt@ Follow Radiopharm Theranostics: Website – Twitter – Linked In – –

Radiopharm Theranostics Granted U.S. Food and Drug Administration Fast Track Designation for RAD101 Imaging in Brain Metastases
Radiopharm Theranostics Granted U.S. Food and Drug Administration Fast Track Designation for RAD101 Imaging in Brain Metastases

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time11-06-2025

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Radiopharm Theranostics Granted U.S. Food and Drug Administration Fast Track Designation for RAD101 Imaging in Brain Metastases

RAD101 in U.S. Phase 2 clinical trial to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin SYDNEY, June 11, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, 'Radiopharm' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. RAD101 is the Company's novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastases. 'The FDA's Fast Track Designation for RAD101 highlights the seriousness of recurrent brain metastases as a condition and the unmet medical need for innovative products that can differentiate between tumor recurrence and radiation necrosis or pseudprogression,' said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. 'RAD101 represents a promising advancement in improving diagnostic precision for brain metastases, offering hope for more effective clinical decision-making in the over 300,000 patients diagnosed annually in the U.S. We are excited to advance our Phase 2 clinical trial and anticipate sharing topline results in the second half of 2025.' The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address an unmet medical need. A Sponsor that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval. A Sponsor's drug receiving Fast Track designation also may be eligible for Priority Review if relevant criteria are met. About the Phase 2 Clinical Trial of RAD101 The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases. About RAD101 RAD101 is the Company's novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London's Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies. About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper. For more information: Riccardo CanevariCEO & Managing DirectorP: +1 862 309 0293E: rc@ Anne Marie FieldsPrecision AQ (Formerly Stern IR)E: Paul Hopper Executive Chairman P: +61 406 671 515 E: paulhopper@ MediaMatt WrightNWR CommunicationsP: +61 451 896 420E: matt@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Radiopharm Theranostics Doses First Patient in Phase 1 ‘HEAT' Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid Tumors
Radiopharm Theranostics Doses First Patient in Phase 1 ‘HEAT' Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid Tumors

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time04-06-2025

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Radiopharm Theranostics Doses First Patient in Phase 1 ‘HEAT' Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid Tumors

Phase 11 First-In-Human study designed to assess safety, tolerability, right dose for Phase 2 and early signs of efficacy of 177Lu-RAD202 in individuals with advanced HER2-positive solid tumors Previous clinical proof-of concept data2 for targeting HER-2 demonstrated the safety and biodistribution of 99mTc-RAD202 in humans SYDNEY, June 04, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, 'Radiopharm' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient in its Phase 1 'HEAT' clinical trial of RAD202, a proprietary nanobody that targets Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide array of advanced solid tumors. The open-label Phase 1 'HEAT' clinical trial is a dose escalation trial of 177Lu-RAD202 that is designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. The study is currently being conducted at clinical centers across Australia. 'Dosing patients in the HEAT clinical trial marks an important milestone in our transition to a clinical-stage company,' said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. 'Despite progressive improvements in the management of metastatic HER2-positive disease, the majority of patients experience disease progression on current standard of care and require further therapeutic options. The dosing of the first patient in the 'HEAT' trial represents a significant step toward achieving RAD202's potential to address an unmet need for HER2-positive metastatic patients who are progressing or unable to tolerate current treatment options. With RAD202, we hope to provide an option that can meaningfully improve clinical outcomes for HER2-positive patients, while preserving their quality of life.' HER2 is overexpressed in breast cancer as well as several other solid tumors and represents a validated target in oncology. RAD202 is a proprietary single domain antibody that targets HER2. Ten HER2-positive breast cancer patients previously dosed in a Phase 1 diagnostic study of RAD202 demonstrated clinical proof-of concept as well as the safety and biodistribution of RAD202, validating its potential for the treatment of advanced HER2-expressing cancers2. Preclinical findings3 examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. Collectively, these data further justify first in humans dose finding studies. 'It is a privilege to be the first centre to administer 177Lu-RAD202, targeting HER2-positive tumors in this Phase 1 clinical trial (HEAT).' said Dr Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at St John of God Murdoch Hospital. 'This opens the possibility of novel therapeutic avenues for patients with aggressive tumor types, including breast, ovarian, gastric, pancreatic, bladder, and several other cancers. With the trust put in us by Radiopharm, we look forward to a successful trial with beneficial outcomes for our patients.' About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper. For more information: Riccardo Canevari CEO & Managing Director P: +1 862 309 0293 E: rc@ Anne Marie FieldsPrecision AQ (Formerly Stern IR)E: Paul Hopper Executive Chairman P: +61 406 671 515 E: paulhopper@ MediaMatt Wright NWR Communications P: +61 451 896 420 E: matt@ ________________________________ 1 Zhao et al, Molecular Pharmaceutics 2021 18 (9), 3616-36223 Altunay B. et al, EP-0136, Eur J Nucl Med Mol Imaging (2024) 51 (Suppl 1): S1–S1026. DOI: 10.1007/s00259-024-06838-zSign in to access your portfolio

Radiopharm Theranostics Reports Preclinical Lu177-B7H3-mAb Data Demonstrating Favourable Biodistribution and High Tumour Uptake
Radiopharm Theranostics Reports Preclinical Lu177-B7H3-mAb Data Demonstrating Favourable Biodistribution and High Tumour Uptake

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time02-06-2025

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Radiopharm Theranostics Reports Preclinical Lu177-B7H3-mAb Data Demonstrating Favourable Biodistribution and High Tumour Uptake

Supports plans to advance the RV01 program to first-in-human therapeutic basket study in solid tumour cancers Data completes preclinical package for Investigational New Drug submission in mid-2025 with Phase 1 therapeutic study initiation expected in 4Q25 SYDNEY, Australia, June 02, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, 'Radiopharm' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that preclinical data from studies with the Lu177-B7H3-monoclonal antibody RV01 demonstrated favourable biodistribution and showed that RV01 maintained high tumour uptake. In addition, the Fc region modifications of the monoclonal antibody (mAb) confirm a shorter half-life, compared to traditional mAbs. The shorter half-life and other Fc modifications have the potential to limit off-target exposure to the isotope and mitigate toxicities associated with traditional monoclonal antibody therapies. RV01 is the Company's B7-H3-targeted radiopharmaceutical therapy designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumours and not in healthy tissues, which is being developed in partnership with MD Anderson Cancer Center. The B7-H3 targeting monoclonal antibody (mAb) is designed to target various solid tumours that express the B7-H3 protein. High expression of this target is associated with a poor prognosis in many cancer types. 'We are especially pleased with these new preclinical data as they further validate earlier preclinical work that showed strong affinity to the target without the extensive circulation time of other monoclonal antibodies. Our mAb has been purposefully modified in the Fc-region with the objective of maintaining the same targeting capabilities together with a reduced half-life. Most mAbs have a typical half-life of over one week, whereas RV01 peaks within one to two days,' stated Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics. 'The antibody shows faster liver excretion in the preclinical experiments, allowing the isotope enough time to effectively target the tumor potentially without the associated toxicities. Unlike peptides or small molecules, mAbs are excreted by the liver, the most radio-resistant organ. This, combined with the faster excretion due to the shortened half-life, potentially offers important advantages compared to excretion via the kidneys, where the elimination of radiopharmaceuticals can result in significant potential toxicities,' added Dr. Voliotis. The new preclinical data corroborate conclusions from earlier preclinical mouse studies that identified a high-affinity antibody highly selective to the cancer-specific 4Ig isoform of the B7-H3 receptor, demonstrated complete regression of established solid tumours with treatment and showed promising evidence of immune system stimulation and the ability to confer immune memory. 'This biodistribution study is the last preclinical work needed to complete the preclinical package for our Investigational New Drug Application (IND) with the U.S. Food and Drug Administration. These data allow us to confirm our guidance to file the IND-submission in mid-2025 and to initiate our first-in-human Phase 1 basket study by the end of this year,' said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper. For more information: Investors:Riccardo CanevariCEO & Managing DirectorP: +1 862 309 0293E: rc@ Anne Marie FieldsPrecision AQ (formerly Stern IR)E: Media:Matt WrightNWR CommunicationsP: +61 451 896 420E: matt@ Follow Radiopharm Theranostics: Website – X – LinkedIn – – An image accompanying this announcement is available at

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