Latest news with #radiopharmaceutical
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 – – –
Globe and Mail
5 days ago
- Business
- Globe and Mail
Perspective Therapeutics Announces Acceptance of VMT-α-NET Data for Presentation at the ESMO Congress 2025
SEATTLE, July 24, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ('Perspective' or the 'Company') (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, today announced that updated data on the Company's [ 212 Pb]VMT-α-NET program have been accepted for presentation as detailed below at the European Society of Medical Oncology (ESMO) Congress 2025 taking place October 17 to 21, 2025 in Berlin, Germany. ESMO plans to release further details for regular abstracts on October 13, 2025. About [ 212 Pb]VMT-α-NET Perspective designed [ 212 Pb]VMT-α-NET to target and deliver 212 Pb to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label, dose-escalation, dose-expansion study ( identifier NCT05636618) of [ 212 Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received a prior RPT. Interim update with a data cut-off date of April 30, 2025 were reported in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2025. Cohort 2 was reopened in August 2024. During 2H 2025, some of the 33 additional patients enrolled after the cohort reopened and through April 30, 2025 will have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to receive at least one scan after their full treatment (up to four doses every eight weeks), if they receive all four doses of treatment per protocol. About Perspective Therapeutics, Inc. Perspective Therapeutics, Inc. is a radiopharmaceutical development company that is pioneering advanced treatments for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-emitting isotope 212 Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity. The Company's melanoma (VMT01), neuroendocrine tumor (VMT-α-NET) and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S. The Company is growing its regional network of drug product candidate finishing facilities, enabled by its proprietary 212 Pb generator, to deliver patient-ready product candidates for clinical trials and commercial operations. For more information, please visit the Company's website at Safe Harbor Statement This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential," or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements concerning, among other things, the Company's ability to pioneer advanced treatments for cancers throughout the body; the Company's plans and the expected timing for the release of additional data from its clinical programs; the ability of the Company's proprietary technology utilizing the alpha emitting isotope 212 Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties; the Company's prediction that complementary imaging diagnostics that incorporate certain targeting moieties provide the opportunity to personalize treatment and optimize patient outcomes; the Company's belief that its "theranostic" approach enables the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity; the Company's ability to grow its regional network of drug product finishing facilities, enabled by its proprietary 212 Pb generator, to deliver patient-ready products for clinical trials and commercial operations; and other statements that are not historical fact. The Company may not actually achieve the plans, intentions, or expectations disclosed in the forward-looking statements, and you should not place undue reliance on the forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements. Certain factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC"), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Globe and Mail
15-07-2025
- Business
- Globe and Mail
Perspective Therapeutics to Provide Business Highlights and Report Second Quarter 2025 Financial Results
SEATTLE, July 15, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ('Perspective' or the 'Company') (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, today announced that it will report its second quarter 2025 financial results and provide a business update on Wednesday, August 13, 2025 before the market opens. The press release will be available on the newsroom section of the Company's website at About Perspective Therapeutics, Inc. Perspective Therapeutics, Inc. is a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-emitting isotope 212 Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This 'theranostic' approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity. The Company's melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S. The Company is growing its regional network of drug product finishing facilities, enabled by its proprietary 212 Pb generator, to deliver patient-ready products for clinical trials and commercial operations. For more information, please visit the Company's website at Safe Harbor Statement This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include statements concerning, among other things, the Company's ability to pioneer advanced treatments for cancers throughout the body; the ability of the Company's proprietary technology utilizing the alpha emitting isotope 212 Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties; the Company's prediction that the use of complementary imaging diagnostics that incorporate the same targeting moieties provides the opportunity to personalize treatment and optimize patient outcomes; the Company's belief that its 'theranostic' approach enables the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity; the Company's ability to grow its regional network of drug product finishing facilities, enabled by its proprietary 212 Pb generator, to deliver patient-ready products for clinical trials and commercial operations; and other statements that are not historical fact. These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements. Certain factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading 'Risk Factors' in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the 'SEC'), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Media and Investor Relations Contacts:
Yahoo
10-07-2025
- Business
- Yahoo
Angelini Ventures Co-leads CHF 79 Million (€84 Million) Series B Financing of NUCLIDIUM to Advance Clinical Development of its Copper-based Radiopharmaceutical Platform
- Regina Hodits, Managing Director to join NUCLIDIUM's Board of Directors Rome, Italy, 10th July 2025 – Angelini Ventures, the corporate venture firm of Angelini Industries focused on investing in companies developing innovative solutions in BioTech and Digital Health, today announces that it has co-led a CHF79 million Series B financing round in NUCLIDIUM, a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform. Angelini Ventures has co-led the financing with Kurma Growth Opportunities Fund, Wellington Partners and Neva SGR (Intesa Sanpaolo Group), with participation from DeepTech & Climate Fonds (DTCF), Bayern Kapital, Eurazeo, Vives Partners, and HighLight Capital, as well as existing investors. Regina Hodits, PhD, Managing Director at Angelini Ventures, will join NUCLIDIUM's Board of Directors. This new investment reflects Angelini Venture's strategy of backing companies with clearly defined product profiles that address high unmet medical needs in well-defined patient populations. The proceeds will fund the clinical development of NUCLIDIUM's Copper-61/Copper-67 (61Cu/67Cu) theranostic pipeline across multiple oncology indications. In parallel, the company will expand its production and manufacturing capabilities through a global production network. NUCLIDIUM's differentiated platform links tumor-targeting molecules with copper isotopes – Copper-61 for diagnostics and Copper-67 for therapeutics – to address current limitations in radiotheranostics, such as suboptimal clinical efficacy and complex manufacturing. Diagnostic results from initial clinical trials in these indications show superior lesion detection and higher tumor-to-background ratios compared with clinically approved tracers. With this financing, NUCLIDIUM will continue expanding its worldwide production and manufacturing network for diagnostics and therapeutics, growing its international team and strengthening strategic collaborations with hospitals and academic centers, initially across Europe and North America. Regina Hodits, PhD, Managing Director at Angelini Ventures said, 'We are pleased to have co-led this financing in NUCLIDIUM alongside other high-quality European investors. At Angelini Ventures we continue to identify and invest in companies that pursue scientifically differentiated opportunities with a clear path to address unmet needs. We look for dynamic founders and situations where our funding and active involvement can help expand therapeutic potential. 'This investment reflects our strong conviction in the future of precision medicine and our belief in NUCLIDIUM's potential to scale as a next-generation company. The team also brings deep radiopharmaceutical expertise and a proven track record of building high-value companies in this space.' Leila Jaafar-Thiel, CEO and Co-founder of NUCLIDIUM added, 'NUCLIDIUM is entering the next clinical phases with its lead compounds to diagnose and treat metastatic prostate, neuroendocrine tumors and breast cancer. The successful Series B financing round reflects the confidence of our investors in NUCLIDIUM's vision and the transformative potential for the diagnostic and therapeutic industry in oncology and nuclear medicine. Their support will further enable us to accelerate the clinical development of our compounds and strengthen our commitment to innovation in precision oncology.' *** Notes to EditorsAbout Angelini Ventures Angelini Ventures, the venture capital arm of Angelini Industries, is a Series A and Series B investment firm focused on accelerating disruptive innovations and trends in BioTech and Digital Health. Angelini Ventures will invest €300 million across a global portfolio in Europe and North America, drawing on a global team, strategic advisors and partners to help entrepreneurs scale their businesses into transformative category-leading companies. To date, Angelini Ventures has invested around €100 million into 22 companies covering a range of therapeutic areas and modalities. Angelini Ventures' BioTech portfolio includes Elkedonia, Therini Bio, Nuevocor, Neumirna, Cour Pharmaceuticals, Nouscom, Pretzel Therapeutics and Freya Biosciences. The Company's Digital Health portfolio includes Vantis Health, Avation, Cadence Neuroscience, Nobi, Noctrix and Serenis. About Angelini Industries Angelini Industries is a multinational industrial group founded in Ancona in 1919 by Francesco Angelini. Today, Angelini Industries represents a solid and diversified industrial reality that employs approximately 5,800 employees and operates in 21 countries around the world with revenues of over two billion euros, generated in the health, industrial technology and consumer goods sectors. A targeted investment strategy for growth, constant commitment to research and development, deep knowledge of markets and business sectors, make Angelini Industries one of the Italian companies of excellence in the sectors in which it About NUCLIDIUM NUCLIDIUM AG is a clinical-stage biotechnology company pioneering the development of next-generation copper-based radiopharmaceuticals for the diagnosis and treatment of cancer. Leveraging copper isotopes – Copper-61 for diagnostics and Copper-67 for therapeutics – NUCLIDIUM is creating a differentiated platform with the potential to overcome existing limitations in radiotheranostics. The company's operations in Switzerland and Germany combine innovative chemistry, deep clinical expertise, and strategic manufacturing capabilities to deliver scalable, accessible, and clinically superior theranostic solutions to patients worldwide. NUCLIDIUM is committed to expanding the reach and efficacy of radiotheranostics, including addressing critical unmet medical needs in oncology and women's health. ContactsAngelini VenturesMartina Palmese, Communications Media contacts for Italy - SEC Newgate ItaliaDaniele Pinosa, Tel. +39 3357233872Fausta Tagliarini; Tel. +39 3476474513Daniele Murgia; Tel. +39 3384330031 Media contacts outside Italy - MEDiSTRAVA Sylvie Berrebi, Sandi Greenwood, Mark Swallowangelinivenutres@ 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
CTV News
08-07-2025
- Health
- CTV News
‘It gives us hope': Quebec expands access to life-extending prostate cancer treatment
A life-altering treatment for prostate cancer with fewer side effects is now more accessible in Quebec. A Quebec man who has spent years fighting for access to a promising prostate cancer treatment says he was overcome with emotion when the province finally approved it last week. Jean Krashevski was first diagnosed with aggressive prostate cancer in 2015. After surgery and 33 rounds of radiation, he hoped the disease was behind him. But within a year and a half, it returned — this time spreading to other parts of his body, including his brain. 'I should be dead by now,' he said. 'But we moved quickly, and we fought hard. This new treatment gives us something we haven't had in a long time: hope.' Pluvicto, the drug for this treatment, is a radiopharmaceutical therapy that delivers targeted radiation directly to prostate cancer cells. It's designed for patients with metastatic castration-resistant prostate cancer who have already undergone hormone therapy and chemotherapy. On July 2, the Quebec government added it to the province's list of publicly covered medications. For Krashevski, who launched a petition a year ago demanding the province fund Pluvicto, it was a long-awaited breakthrough. 'I couldn't believe it when we got the news,' he said. 'I was with my family and we all cried because this treatment is a game-changer — not just for me, but for so many men waiting for this.' Dr. Frédéric Arsenault, president of the Association of Nuclear Medicine Specialists of Quebec, calls the decision 'a milestone.' 'There was a clear gap in treatment options for patients with advanced prostate cancer,' he said. 'Pluvicto fills that gap — it not only prolongs life, but it does so with better quality and fewer to no side effects.' The therapy works by binding to a protein found on the surface of prostate cancer cells called PSMA (prostate-specific membrane antigen). A radioactive atom then delivers targeted radiation directly to the tumour. Because it attacks only the cancer cells and not healthy tissue, Dr. Arsenault explained that the treatment avoids some of the harsh side effects of traditional therapies, including erectile dysfunction, severe fatigue, and damage to surrounding organs. In clinical trials, Pluvicto led to a 50 per cent drop in PSA levels, the key blood marker used to monitor prostate cancer, and significantly delayed disease progression. Until now, patients in Quebec had to pay $27,000 per dose out of pocket, with a full course of six doses totalling over $160,000. Dr. Arsenault said some were able to access it under RAMQ's 'exceptional medications' program, but only on a case-by-case basis with added red tape. Years of waiting and fighting Like many medical experts and prostate cancer patients, Krashevski had been following Pluvicto's development closely. His wife Céline, a biologist, has helped him navigate research, protocols, and treatment options since his diagnosis. Together, they advocated for the drug's approval in Quebec, speaking to doctors, politicians, and the media. 'It was an uphill battle,' he said. 'Some officials were sympathetic but told me their hands were tied, others were dismissive.' Krashevski has undergone multiple rounds of hormone therapy and other treatments that have taken a toll on his body and mind. He continues to stay active — practicing martial arts in a more meditative way — but said the effects of cancer are far-reaching. 'Your sex life changes entirely — you also lose your strength and your muscle mass,' he said. 'Psychologically, it's tough too because you're always just gaining time — one more day, one more treatment — waiting and hoping that something new will come.' He has just undergone a new round of imaging tests and is waiting for the green light to begin Pluvicto. 'I'd love to start tomorrow but there's a protocol,' he said. 'Raising awareness remains key' Krashevski said he wants other men to speak up about prostate cancer — and get screened early, especially if there's a family history. 'It's a simple blood test, and, if you catch it early, the treatment is much easier,' he said. 'Once it metastasizes, it's a whole different ballgame.' He also urged patients to be proactive in their own care — to ask questions, seek second opinions, and bring a trusted person to medical appointments to take notes and advocate. 'We have great doctors here in Quebec, but time is of the essence when you're diagnosed,' he said. 'Don't wait.' Another encouraging aspect of Pluvicto is its potential beyond treating prostate cancer. Dr. Arsenault said the drug is being studied for a range of other cancers, including breast, gastric, liver, and pancreatic cancer. That research is already underway, including in Quebec at McGill's Jewish General Hospital. 'We think that in the next 10 years, there could be 10 other types of cancer or other diseases that will benefit from this kind of treatment,' he said. For now, Krashevski is focused on the next steps in his care. And for the first time in a long time, he says, he's optimistic. 'For a while, I had lost hope, but this news gives me the chance to keep fighting,' he said. 'And, after all these years, I'm still hoping for a chance at full remission.'
