Latest news with #RadiopharmTheranostics
Yahoo
19 hours ago
- Business
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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
Yahoo
3 days ago
- Business
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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
Yahoo
3 days ago
- Business
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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
12-05-2025
- Business
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Radiopharm Theranostics Accelerates 177Lu-RAD204 Phase 1 Dose Escalation Clinical Trial Based on Positive Recommendation from Data Safety and Monitoring Committee (DSMC)
DSMC concluded that Phase 1 study may continue as planned without any modifications On track to complete the enrollment of the first two cohorts by mid-2025 SYDNEY, May 12, 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, announced today that it has achieved a key milestone in its ongoing clinical development program for its clinical-stage radiotherapeutic asset, 177Lu-RAD204, as the Data and Safety Monitoring Committee (DSMC) has approved to proceed to the next dose in its Phase 1 clinical trial in patients with PD-L1 positive advanced cancers1. The DSMC is an independent multidisciplinary group that conducts detailed reviews of unblinded study data, discusses potential safety concerns and provides recommendations regarding trial continuation. 'We greatly appreciate the DSMC's judicious review of our first cohort of patients in the Phase 1 study of 177Lu-RAD204, which allows us to advance to the higher dose cohort in a variety of PD-L1- driven cancers,' said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. 'With this clearance from the DSMC, the increased number of active centers and expansion to multiple tumor types beyond Non-Small Cell Lung Cancer (NSCLC), we expect to accelerate our timelines for complete enrolment of the next cohort by mid-2025. We believe that RAD204 has the potential to strongly improve clinical outcomes for patients with PD-L1 positive advanced cancers and we look forward to seeing data from the first two cohorts of patients later this year.' The DSMC reviewed the first cohort of four patients treated with 30mCi of 177Lu-RAD204 and confirmed that there was positive safety, pharmacokinetic and biodistribution data and agreed that the study may continue without modifications. The second cohort of patients will start at 60mCi of Lu177 rather than 40mCi previously assumed in the protocol. The second cohort of patients is expected to be enrolled by mid-year 2025 and will include expansion to multiple tumor types including NSCLC, Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial Cancer. There are currently four clinical trial sites actively screening and recruiting patients in Australia. About 177Lu-RAD204: RAD204 is a single-domain monoclonal antibody (sdAb) that targets PD-L1, a protein that helps control the immune system and is overexpressed in many solid cancers, making it an attractive therapeutic target in multiple tumor types, including NSCLC, SCLC, TNBC, Cutaneous Melanoma, HNSCC, and Endometrial Cancer. Previously published Phase I imaging data of 16 NSCLC patients with 99Tc-RAD204 demonstrated that the diagnostic compound is safe and is associated with acceptable dosimetry2. Tumor targeting with radioimmunotherapies such as 177Lu-RAD204 has the potential to address resistance mechanisms to current standard-of-care treatment options. 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 – – 1 ID: NCT063059622 Xing Y, et al. J Nucl Med. 2019 Sep;60(9): 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 –
