Latest news with #Radiopharm
Yahoo
6 days ago
- Business
- Yahoo
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
Yahoo
02-06-2025
- Business
- Yahoo
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
Yahoo
19-05-2025
- Business
- Yahoo
ITM and Radiopharm Sign Supply Agreement for n.c.a. Lutetium-177
GARCHING / MUNICH, Germany and SYDNEY, May 19, 2025 (GLOBE NEWSWIRE) -- ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Radiopharm Theranostics (ASX:RAD; NASDAQ: RADX 'Radiopharm'), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, today announced the signing of a supply agreement that will provide Radiopharm with ITM's medical radioisotope, non-carrier-added Lutetium-177 (n.c.a. 177Lu), to enable its usage in the clinical and potential future commercial development of the 177Lu-based molecules in Radiopharm's development pipeline. Under the terms of the agreement, Radiopharm will use ITM's n.c.a. 177Lu across its clinical pipeline, including in key programs such as RAD 204 (PD-L1-targeting nanobody, Phase 1), RAD 202 (HER2-targeting nanobody, Phase 1), and RV01 (B7-H3-targeting monoclonal antibody, preclinical), for the treatment of solid tumors. Coupled with the targeting molecules that are designed to deliver ITM's n.c.a. 177Lu directly to tumor sites, the radioisotope emits therapeutic beta radiation with the aim to destroy malignant cells in a highly precise and localized manner. 'Ensuring supply of key isotopes continues to be a priority for our team, allowing us to accelerate our clinical programs,' said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. 'Lutetium-177 is required for three of our more advanced assets and this supply agreement with a radiopharmaceutical leader like ITM is another important step to ensure quality, reliability, and redundancy in our clinical development plans.' ITM's n.c.a. 177Lu is a market-approved, highly pure form of the beta-emitting radioisotope, Lutetium-177, that can be linked to tumor-specific targeting molecules for the treatment of various cancers and has been successfully used in numerous clinical and commercial radiopharmaceutical cancer treatments. ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. 177Lu and has marketing authorization in the EU (brand name EndolucinBeta®). 'As the leading global manufacturer of non-carrier-added Lutetium-177, we are just as committed to supplying our global partners with high-quality medical radioisotopes as we are to supplying our own pipeline,' said Andrew Cavey, CEO of ITM. 'Supporting Radiopharm in the advancement of their therapeutic candidates reflects our shared dedication to delivering improved treatment options to people living with cancer.'About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple phase 3 studies, combining the company's high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. Radiopharm TheranosticsRadiopharm 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 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@ Paul Hopper Executive Chairman P: +61 406 671 515 E: paulhopper@ MediaMatt WrightNWR CommunicationsP: +61 451 896 420E: matt@ ITM ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@ Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@ in to access your portfolio
Yahoo
07-05-2025
- Business
- Yahoo
Radiopharm Theranostics to Participate in the D. Boral Capital Inaugural Global Conference
Radiopharm Theranostics SYDNEY, May 07, 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 members of management will be participating in the D. Boral Capital Inaugural Global Conference on May 14, 2025, in New York City. To register for one-on-one meetings with management in New York City, interested parties should contact John Perez at jperez@ 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 Canevari CEO & Managing Director P: +1 862 309 0293 E: rc@ Anne Marie Fields Precision AQ (formerly Stern IR) E: Media: Matt Wright NWR Communications P: +61 451 896 420 E: matt@ Follow Radiopharm Theranostics: Website – X – LinkedIn – InvestorHub –
Associated Press
28-04-2025
- Business
- Associated Press
Radiopharm Theranostics Doses First Patient with 18F-RAD101 in U.S. Phase 2b Imaging Study of Brain Metastasis
Phase 2b study evaluating diagnostic performance of 18F-RAD101 for suspected recurrent brain metastases from solid tumors of different origins Underscores Radiopharm's commitment to developing transformative oncology radiopharmaceuticals SYDNEY, April 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 the dosing of the first patient in its U.S. Phase 2b imaging study of 18F-RAD101 in suspected recurrent brain metastasis. The U.S. multicenter, open-label, single arm Phase 2b clinical trial1 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. RAD101 is a 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. Disruption of FASN activity allows for the accurate detection of cancer cells, representing a strongly viable target for the imaging of brain metastasis. Positive data from the Imperial College of London's Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases showed significant tumor uptake that was consistent with and independent from the tumor of origin.2 'We are proud to pioneer the first U.S. clinical trial of RAD101,' said Harshad R. Kulkarni, MD, Chief Medical Advisor at BAMF Health and Principal Investigator of this Phase 2b study. 'This marks an important step toward improving diagnostic precision and enabling more evidence-based, individualized treatment decisions for patients with brain metastases following stereotactic radiosurgery.' 'This trial is an excellent illustration of BAMF Health's clinical trials platform in action,' added BAMF Health's Director of Clinical Trials. 'Our Radiopharmacy is producing the imaging agent on-site, our clinic team is caring for the patient and providing the best image in the world, and our clinical trials team expertly coordinates it all. BAMF's facility and team were built to do trials just like this.' 'Current standard of care imaging is less sensitive in discriminating between tumor recurrence and radiation necrosis in patients with brain metastasis who have received anticancer treatments, including radiation,' said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics Ltd. '18F-RAD101 has the strong potential to improve diagnostic accuracy of brain metastases, and holds promise for discriminating between treatment effect and true progression in the more than 300,000 patients diagnosed with brain metastasis each year in the U.S. alone. We look forward to advancing this clinical trial and to reporting topline data 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 About BAMF Health BAMF Health is the world's first vertically integrated platform for intelligence-based precision medicine. Headquartered in Grand Rapids, Michigan, BAMF Health employs the most advanced theranostic imaging technology to detect and treat cancer and other diseases and conduct advanced clinical trials. Our overriding mission is to empower patients to become people again. With a team of data scientists, researchers, software engineers, and clinicians —all working in lockstep—we're making good on it. To learn more about BAMF Health, visit Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper. For more information: Investors: Riccardo Canevari CEO & Managing Director Radiopharm Theranostics P: +1 862 309 0293 E: [email protected] Andrew Dymon Precision AQ (formerly Stern IR) [email protected] Media: Matt Wright NWR Communications P: +61 451 896 420 E: [email protected] Follow Radiopharm Theranostics: Website – Twitter – Linked In – InvestorHub – ________________________ 1 2 S. Islam et. Al., EJNMMI; 07 February 2025.
