Latest news with #RiccardoCanevari
Yahoo
2 days ago
- Business
- Yahoo
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 – – –
Yahoo
11-06-2025
- Business
- Yahoo
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
Yahoo
04-06-2025
- 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
01-06-2025
- Business
- Yahoo
Independent Non-Executive Director of Radiopharm Theranostics Picks Up 48% More Stock
Even if it's not a huge purchase, we think it was good to see that Ian Turner, the Independent Non-Executive Director of Radiopharm Theranostics Limited (ASX:RAD) recently shelled out AU$87k to buy stock, at AU$0.029 per share. That purchase might not be huge but it did increase their holding by 48%. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. The MD, CEO & Director Riccardo Canevari made the biggest insider purchase in the last 12 months. That single transaction was for AU$241k worth of shares at a price of AU$0.031 each. So it's clear an insider wanted to buy, even at a higher price than the current share price (being AU$0.024). It's very possible they regret the purchase, but it's more likely they are bullish about the company. We always take careful note of the price insiders pay when purchasing shares. As a general rule, we feel more positive about a stock if insiders have bought shares at above current prices, because that suggests they viewed the stock as good value, even at a higher price. In the last twelve months insiders purchased 22.43m shares for AU$772k. But insiders sold 1.50m shares worth AU$43k. Overall, Radiopharm Theranostics insiders were net buyers during the last year. Their average price was about AU$0.034. These transactions suggest that insiders have considered the current price attractive. You can see the insider transactions (by companies and individuals) over the last year depicted in the chart below. If you click on the chart, you can see all the individual transactions, including the share price, individual, and the date! Check out our latest analysis for Radiopharm Theranostics Radiopharm Theranostics is not the only stock that insiders are buying. For those who like to find small cap companies at attractive valuations, this free list of growing companies with recent insider purchasing, could be just the ticket. Looking at the total insider shareholdings in a company can help to inform your view of whether they are well aligned with common shareholders. We usually like to see fairly high levels of insider ownership. From our data, it seems that Radiopharm Theranostics insiders own 11% of the company, worth about AU$6.3m. Overall, this level of ownership isn't that impressive, but it's certainly better than nothing! It's certainly positive to see the recent insider purchase. We also take confidence from the longer term picture of insider transactions. However, we note that the company didn't make a profit over the last twelve months, which makes us cautious. We would certainly prefer see higher levels of insider ownership but analysis of the insider transactions suggests that Radiopharm Theranostics insiders are expecting a bright future. While it's good to be aware of what's going on with the insider's ownership and transactions, we make sure to also consider what risks are facing a stock before making any investment decision. When we did our research, we found 4 warning signs for Radiopharm Theranostics (2 make us uncomfortable!) that we believe deserve your full attention. But note: Radiopharm Theranostics may not be the best stock to buy. So take a peek at this free list of interesting companies with high ROE and low debt. For the purposes of this article, insiders are those individuals who report their transactions to the relevant regulatory body. We currently account for open market transactions and private dispositions of direct interests only, but not derivative transactions or indirect interests. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
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
