This study aims to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in patients with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC).
The name of the study drug involved in this research study is:
-177Lu-PSMA-617 (a type of radioligand therapy)

Start Date01 Nov 2025

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06783348

/ Not yet recruitingPhase 2IIT

Phase II Trial Evaluating the Efficacy of 177Lutetium-PSMA-617 Treatment in Patients With Metastatic Clear Cell Renal Carcinoma Cell With Progressive Disease on First-line or Second-line Systemic Treatment

Background This study is for adults with advanced kidney cancer that has spread to other parts of the body and has continued to progress despite treatment with immunotherapy and targeted therapy. Unfortunately, treatment options at this stage of the disease are limited. The existing treatments' ability to work against cancer has not been fully looked into.
Rationale The goal of this study is to examine if a new drug treatment called 177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active ingredient 177Lutetium-PSMA and has been used as a standard treatment for advanced prostate cancer since December 2022, can also help treat advanced kidney cancer.
The drug 177Lu-PSMA-617 is being tested as an experimental treatment that targets a specific protein on cancer cells. This protein, known as prostate-specific membrane antigen (PSMA), is present on the surface of kidney cancer cells. Therefore, before the treatment begins, participants will undergo a PET (positron-emission tomography) scan to check if their kidney cancer cells express high levels of PSMA. This scan uses a small amount of radioactive material (in the form of 177Lutetium) to visualize the presence of PSMA on the cancer cells. Only participants who test positive for PSMA can take part in the study. In this approach, PSMA serves two purposes. First, it helps assess whether the cancer expresses this protein and allows 177Lu-PSMA-617 to specifically target and attach to the cancer cells. Second, 177Lu-PSMA-617 delivers a small amount of radiation directly to the tumour, which helps kill cancer cells while minimizing damage to normal cells. This type of treatment is known as a radiopharmaceutical.
Objective The primary aims are to find out if 177Lu-PSMA-617 is useful against kidney cancer and to assess its safety. Throughout the study, participants will undergo several imaging assessments to check their disease and response to treatment.
The study also includes the collection of tissue samples. Together with the information collected from the imaging assessments, this will allow further research into markers that may lead to earlier detection of tumour spread or help identify individuals who may benefit more from treatment with 177Lu-PSMA-617.
Treatment All participants will receive 177Lu-PSMA-617 through an intravenous injection at a standard dose of 7,400 MBq (megabecquerel: a measure of radioactivity). Treatments will be administered approximately every six weeks, for a maximum of six times.
Blood tests are done before and during treatment to check the participant's health and to detect any early side effects from the treatment. Different types of scans are performed before, during, and after 177Lu-PSMA-617 administration to check how well the treatment is working. After treatment ends, follow-up visits will be scheduled every six weeks during the first year. In the second year, your doctor will decide how often you need to come in for visits. These appointments are important for monitoring how the body continues to respond to the treatment. The entire study period will last approximately two years from the time of study entry.
Participants
The study will include approximately 56 participants who will be tested for PSMA expression, to obtain a minimum of 48 participants expressing PSMA entering the study. To qualify, participants must:
* Be diagnosed with advanced kidney cancer previously treated with immunotherapy and targeted therapy.
* Test positive for PSMA on a PET scan.
* Be generally healthy and able to perform daily activities.
* Be at least 18 years of age.
Benefit-risk analysis The drug 177Lu-PSMA-617 has proven to work well in treating advanced prostate cancer and could be a promising new treatment possibility for kidney cancer, although this has not yet been shown. By joining this study, participants will contribute to valuable research to better understand kidney cancer and improve treatment options for future patients. Participating in this study offers a chance to try a new treatment, which might help people with advanced kidney cancer live longer and prevent the disease from getting worse, especially for those who have limited treatment options left after immunotherapy and targeted therapy.
With all new treatments, there are possible risks and side effects associated with them. Side effects of the drug 177Lu-PSMA-617 may include feeling tired, nausea, dry mouth, loss of appetite, and changes in blood cells. While not all side effects are known yet, the study team will carefully follow participants for any side effects during and after treatment. It is important to understand that while the study is being done to provide new information, there are still some questions on the treatment's safety and how well it will work.

Start Date30 Oct 2025

Sponsor / Collaborator-

100 Clinical Results associated with Lutetium (177 Lu) Vipivotide Tetraxetan

100 Translational Medicine associated with Lutetium (177 Lu) Vipivotide Tetraxetan

100 Patents (Medical) associated with Lutetium (177 Lu) Vipivotide Tetraxetan

597

Literatures (Medical) associated with Lutetium (177 Lu) Vipivotide Tetraxetan

01 Jul 2025·NUCLEAR MEDICINE AND BIOLOGY

Enhancing the therapeutic index of [211At]YF2 with iodo pseudo carrier: A simple strategy for reducing accumulation in kidneys, salivary and lacrimal glands

Article

Author: Feng, Yutian ; Vaidyanathan, Ganesan ; Banks, Rebecca L ; Huynh, Truc T ; Zalutsky, Michael R

INTRODUCTION:

Low-molecular-weight (LMW) PSMA-targeted agents have enjoyed success; however, their off-target toxicity in normal tissues such as kidneys, salivary gland and lacrimal gland can be dose limiting. Herein, we have evaluated the effect of co-administration of the non-radioactive iodo pseudo carrier, iodo YF2, on the normal tissue uptake of [²¹¹At]YF2 in xenografted mice. The potential implications for clinical translation of these studies were investigated by evaluating the binding of LMW PSMA-targeted agents to murine and human PSMA.

METHODS:

[²¹¹At]YF2 was synthesized following established protocols. Groups of 5 mice bearing subcutaneous PSMA+ PC3 PIP xenografts received [²¹¹At]YF2 co-injected with varying i.v. doses of iodo YF2 (0-2 nmol), and the biodistribution was evaluated at 1 h post injection (p.i.). In another study, the biodistribution of [²¹¹At]YF2 alone and [²¹¹At]YF2 co-administered with 1.5 nmol iodo YF2 was evaluated at 1 and 8 h p.i. Bead-based radioligand binding assays were conducted for [¹³¹I]YF2 and several other LMW agents to compare their binding to human and murine PSMA.

RESULTS:

At 1 h, no significant difference was seen in kidney uptake of [²¹¹At]YF2 at iodo YF2 concentrations of 0, 0.05 and 0.1 nmol (p > 0.05), but renal accumulations significantly reduced by co-administering 2.0 nmol iodo YF2 (p < 0.0001). Decreases in salivary and lacrimal gland uptake also were observed at 1 h for [²¹¹At]YF2 co-injected with 0.1 nmol iodo YF2 (p < 0.05). A follow-up study revealed a kidney uptake of 1.8 ± 0.4 % ID/g for [²¹¹At]YF2 with 1.5 nmol iodo YF2, compared to 46.5 ± 7.7 % ID/g for [²¹¹At]YF2 alone at 8 h. Tumor uptake showed no significant difference (p > 0.05) between [²¹¹At]YF2 alone (17.1 ± 8.8 % ID/g at 1 h; 13.6 ± 5.3 % ID/g at 8 h) and [²¹¹At]YF2 plus 1.5 nmol iodo YF2 (12.8 ± 2.7 % ID/g at 1 h; 14.1 ± 3.2 % ID/g at 8 h). Bead-based radioligand binding assays showed that [¹³¹I]YF2 has the highest binding fractions to both human PSMA (94.1 ± 0.1 %) and murine PSMA (92.5 ± 0.2 %) with minimal differences between the two, while [¹⁷⁷Lu]PSMA-617 had the greatest species-dependent disparity with a binding fraction of 90.5 ± 0.3 % to human PSMA and 60.9 ± 1.4 % to murine PSMA.

CONCLUSIONS:

Co-administration of iodo YF2 reduced kidney uptake of [²¹¹At]YF2 and decreased accumulation in normal tissues with no significant change in tumor uptake. In some cases, there was a significant difference in binding to human and murine PSMA among LMW PSMA-targeted agents suggesting that particularly for some agents, applying mouse data to predict human dosimetry must be done with caution.

23 Jun 2025·Journal of Cancer Research and Clinical Oncology

Combinations of treatments based on radiotherapy or radionuclides to enhance immunotherapy efficacy in advanced prostate cancer: a systematic review.

Review

Author: Roberto, Rosenfeld ; Marco, Badalamenti ; Maria, Iannantuono Giovanni ; Elias, Chandran ; Michele, Ghidini ; Stefano, Sganga ; Marta, Scorsetti ; Sveva, Mortellaro ; Ornella, Garrone ; Ciro, Franzese

BACKGROUND:

Prostate cancer (PCa) has been considered an immunologically "cold tumor". Indeed, in advanced PCa, immune checkpoint inhibitors (ICIs) or anti-tumor vaccines have shown poor results in phase II and phase III trials with the exception of sipuleucel-T that showed a modest survival benefit. Radiotherapy and Targeted radioisotopes, such as ²²³Radium or ¹⁷⁷Lu-PSMA-617 monotherapy, contributed in prolonging the progression-free survival of PCa patients in second or third line. However, potential benefits of combination with immune therapies were inconstantly investigated and outcomes often were discordant.

OBJECTIVE:

Aim of this systematic review was to gather and analyze clinical evidence about benefits and risks of combining ionizing-radiation-based treatments with the main immunotherapies administed in clinical and experimental oncology for the setting of metastatic PCa.

METHODS:

We performed a systematic review according to the PRISMA-ScR criteria, investigating PubMed, Web of science, Embase and Medline databases from February 2000 to April 2024, searching for phase I to phase III clinical trials associating radiotherapy with immunotherapy (RT/IT) in metastatic PCa patients.

CONCLUSION:

We observed that combination of Ipilimumab with stereotactic beam radiotherapy (SBRT) at the dose of 8 Gy performed about 12 days (range 2-21) before immunotherapy was liked with trials with a significative gain in progression-free survival. Furtherly, we described better objective responses when immunotherapies, were associated with SBRT than radionuclides An exception was ¹⁷⁷Lu-PSMA-617, which showed promising synergic results after few cycles of standard doses, suggesting a possible enhancing of immune system, in particular when associated with anti-PD1 (pembrolizumab). Due to the few data reported in literature, both for radiotherapy and radionuclides, however, future randomized trials should confirm these data.

19 Jun 2025·RADIATION PROTECTION DOSIMETRY

Evaluation of external radiation exposure in patients treated with 177Lu-PSMA and radiation safety assessment of the patient caregivers

Article

Author: Abdolmaleki, Mohammadreza ; Koosha, Fereshteh ; Bayat, Zeinab ; Farzanehfar, Saeed ; Kasraie, Nima ; Abbasi, Mehrshad ; Sheikhzadeh, Peyman

Abstract:

This study evaluates dose rates at various distances and time intervals after 177Lu-PSMA treatment and assesses caregivers’ effective doses. Dose rates were measured in 47 patients at 0.5 and 1 m up to 168 h post-injection. Initial dose rates were 34.6 ± 9 μSv (0.5 m) and 24.6 ± 5 μSv (1 m) at 5 min, peaking at 48.5 ± 15 and 31.6 ± 8 μSv at 1 h, then declining significantly over time. Caregivers’ effective doses ranged from 20 to 1170 μSv, remaining below international safety limits. This study demonstrates that patient dose rates at a distance of 1-m decline to below 30 μSv/h within 2–3 h post-injection and fall further to under 20 μSv/h after 6 h. Patients may be considered radiologically safe approximately four days post-procedure, depending on individual factors. While 177Lu-PSMA is a safe and effective PRRT modality, strict safety measures are essential to minimize exposure risks.

386

News (Medical) associated with Lutetium (177 Lu) Vipivotide Tetraxetan

30 Jun 2025

·www.prnewswire.com

Alpha Fusion, Inc. and Curadh MTR, Inc. to Enter into Strategic Partnership to Advance Global Development of Astatine-211 Based Radiopharmaceuticals

TOKYO, June 30, 2025 /PRNewswire/ -- Alpha Fusion, Inc. ("Alpha Fusion") and Curadh MTR Inc. ("Curadh") announced plans to enter a strategic partnership, including a Joint Venture to broadly advance the global development of Astatine-211 (At-211) based radiopharmaceuticals. The collaboration combines Alpha Fusion's leading role in At-211 drug discovery and early clinical work in Japan, with Curadh's global expertise in radiopharmaceutical development. The Joint Venture will focus on clinical development of lead products in the US as well as broadly developing a pipeline of At-211 products. The partners announced their plans at the World Astatine Community Meeting. The therapeutic potential for At-211 by the Joint Venture was highlighted in talks given by the companies' scientific/clinical founders. Tadashi Watabe, M.D., Ph.D., FANMB, Department of Radiology, Graduate School of Medicine, University of Osaka presented "Progress Update on Astatine Clinical Trials in Osaka" as Principal Investigator of the studies. Alison Armour, MD., FRCP., FRCR, Founder and CMO of Curadh talked on "Why Astatine Will Be Important for The Future of Molecularly Targeted Radiopharmaceuticals" "Alpha Fusion is advancing its pipeline and building a highly efficient supply chain for At-211 using cyclotrons and GMP manufacturing in collaboration with partners across the globe" stated CEO Sunao Fujioka. "Our strategic partnership with Curadh, who has deep expertise in radiopharmaceuticals, will significantly accelerate expansion into the US and global market". "This strategic partnership with Alpha Fusion's foundational At-211 drug discovery platform and first-in-human studies strengthens our position in next-generation radiopharmaceuticals" added Glenn Kazo, CEO of Curadh. "Astatine's unique properties as a halogen emitter with a short half-life makes it one of the most promising alphas for molecularly targeted cancer therapy" About Alpha Fusion: Alpha Fusion Inc., established to commercialize Astatine drug discovery based on research from Osaka University and the Japan Science and Technology Agency, is dedicated to unleashing the therapeutic potential of Astatine therapy in the fast-emerging field of Targeted Alpha Therapy. Alpha Fusion Inquiries About Curadh. Curadh MTR, Inc., is dedicated to advancing second-generation radiopharmaceuticals through innovative drug design and strategic partnerships combining novel targets and new radioisotopes. Founded by Dr. Alison Armour, who led the clinical development of Pluvicto®, the world's leading radiopharmaceutical drug, Curadh is headed by an expert team in MTR development. Curadh Inquiries SOURCE Alpha Fusion Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

23 Jun 2025

·www.globenewswire.com

Illuccix Approved in U.S. for Patient Selection for Pre-Taxane RLT

MELBOURNE, Australia and INDIANAPOLIS, June 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting. The update applies to Illuccix’s third indication, for selection of patients who are indicated for PSMA1-directed therapy as described in the Prescribing Information of the therapeutic products. The label expansion follows the FDA’s approval of an expanded label for Pluvicto®2 (lutetium Lu177 vipivotide tetraxetan) for use in metastatic castration-resistant prostate cancer (mCRPC) patients after treatment with androgen receptor pathway inhibitor (ARPI) therapy and before chemotherapy3. With RLT now approved for use earlier in the patient journey, the clinical utilization of Illuccix® is expected to increase by at least 20,000 scans annually4. Scott T. Tagawa, MD, a genitourinary (GU) oncologist in New York said, “It is pleasing to see the ability to use gallium-68 PSMA-PET for patient selection expanded. This empowers clinicians to make more informed, personalized decisions earlier in the disease course and access life-prolonging targeted radionuclide therapy for more patients with prostate cancer.” Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, “We’re pleased that the U.S. label for Illuccix has been expanded to support patient selection for RLT in the pre-taxane setting, aligning with the evolving treatment landscape. PSMA-PET imaging has become a standard of care in the detection and management of prostate cancer. With this update, patients can now benefit from the high diagnostic accuracy of Illuccix to identify those most likely to respond to PSMA-targeted therapy, even earlier in their treatment journey.” INDICATIONS AND USAGE Illuccix, after radiolabeling with Ga 68, is for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy With suspected recurrence based on elevated serum prostate-specific antigen (PSA) levelFor selection of patients who are indicated for PSMA-directed therapy as described in the Prescribing Information of the therapeutic products IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONS Risk for MisinterpretationImage interpretation errors can occur with Illuccix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Imaging Prior to Initial Definitive or Suspected Recurrence TherapyThe performance of Illuccix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Illuccix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Radiation RisksGallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration. ADVERSE REACTIONSThe safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%). Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills. DRUG INTERACTIONSAndrogen deprivation therapy and other therapies targeting the androgen pathwayAndrogen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established. Please note that this information is not comprehensive.Please see the Full Prescribing Information here. You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing: pharmacovigilance@telixpharma.com. Dr. Tagawa has served as a paid consultant to Telix and his institution has received research funding. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Telix Media Relations (U.S.) Eliza Schleifstein ES Media Relations Email: eliza@schleifsteinpr.com Phone: 917-763-8106 About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, is approved and commercially available in multiple countries globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA5. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. _________________________1 Prostate-specific membrane antigen2 Pluvicto is a registered trademark of Novartis AG and/or its affiliates.3 28 March 2025, FDA Statement: for patients who have been treated with ARPI therapy and are considered appropriate to delay taxane-based chemotherapy.4 Based on licensed indication for Pluvicto in mCRPC patients who have been treated with androgen receptor (AR) pathway inhibition.5 Telix ASX disclosure 21 March 2025.

Drug ApprovalClinical ResultRadiation Therapy

16 Jun 2025

·www.prnewswire.com

Clarivate Identifies Radioligand Therapy Innovators as Companies to Watch in the Future of Precision Oncology

New Report Highlights Emerging Leaders Advancing Next-generation Radiopharmaceuticals, Reshaping Cancer Care Through Targeted Innovation and Strategic Growth LONDON, June 16, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a leading global provider of transformative intelligence, today announced the release of a new Companies to Watch report, Radioligand Innovators Ushering in a New Era of Precision Oncology. The report spotlights pioneering companies that are redefining the drug discovery and development landscape through advancements in radioligand therapies (RLTs)—a rapidly evolving class of therapeutics that combines nuclear medicine with precision-targeted biotechnology to treat cancer with heightened specificity. Drawing on proprietary data, expert analysis and insights into therapeutic benefit, financing activity and R&D momentum, the report highlights why these organizations are considered high-impact innovators. This latest edition follows previous Companies to Watch reports focused on RNA-based technologies, artificial intelligence/ machine learning (AI/ML), next-generation gene-editing and antibody-drug conjugates (ADCs). Radioligand therapies represent one of the most promising frontiers in oncology, offering highly specific delivery of radioactive isotopes to tumor cells while minimizing damage to healthy tissue. These agents are rapidly gaining momentum as both scientific breakthroughs and strategic investments accelerate across the global pharmaceutical landscape. Michael Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, said: "Radioligand therapies are emerging as a cornerstone of precision oncology, combining decades of research in nuclear medicine with the latest innovations in biotechnology. This report identifies the innovators that are pushing the boundaries of what's possible in cancer care — and highlights the market, scientific and strategic signals that make them companies to watch." David Bejker, Chief Executive Officer, Affibody, said: "Radioligand therapies (RLTs) are transforming the promise of precision medicine into reality, enabling treatments that are finely tuned to the unique characteristics of each patient and their tumor, rather than relying on one-size-fits-all solutions. By uniting the precision of targeted drug delivery with the power of radiotherapy, RLTs use tumor-seeking molecules linked to therapeutic radioisotopes to deliver radiation directly to cancer cells, minimizing damage to healthy tissue and opening a new frontier in personalized cancer care." The report offers a detailed view of the evolving RLT landscape, highlighting the science, clinical promise and market momentum behind this precision approach. It profiles emerging innovators; explores key trends in M&A, funding and partnerships; and examines how differentiated R&D strategies and IP positioning set companies apart. The report also addresses challenges in manufacturing and regulation while assessing advances in alpha-emitting isotopes, combination therapies and the infrastructure needed to deliver next-generation radiotherapies at scale. The Radioligand Companies to Watch are: Affibody, founded by researchers at the KTH Royal Institute of Technology and Karolinska Institutet, has a mission of addressing medical needs with pioneering treatments that can improve the lives of patients with serious diseases. As a clinical stage biopharmaceutical company, it has pre-clinical and clinical development programs in oncology and immunology, with a broad product pipeline focused on developing innovative next-generation biopharmaceutical drugs based on its proprietary technology platform, Affibody® molecules. Alpha-9 Oncology is developing and advancing a pipeline of differentiated and highly targeted radiopharmaceuticals as potentially life-improving treatments for various malignancies. The company's bespoke, iterative process leverages the team's deep expertise in modifying peptides, small molecules and small biologics to inform target selection, molecule design, formulation and clinical evaluation. Ariceum Therapeutics was launched after the acquisition of the rights for its lead product, satoreotide (SSO110), from Ipsen, which has remained a shareholder in the company. Satoreotide is a proprietary peptide derivative that binds to somatostatin receptor 2 (SSTR2), which is overexpressed in neuroendocrine tumors and some aggressive cancers. The company is developing radiopharmaceutical theranostic pairs focusing on aggressive tumors such as small-cell lung cancer (SCLC) and Merkel cell carcinoma (MCC). Convergent Therapeutics is developing radioantibodies, by conjugating alpha radionuclides to antibodies that target cancer cells. Its lead candidate, CONV01-α (Ac-225 rosopatamab tetraxetan), is in phase 2 trials for prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Perspective Therapeutics, a clinical-stage, radiopharmaceutical company, has adopted a theranostic approach using its proprietary chelator technology platform that enables radiolabeling of targeting moieties against cancers with therapeutic isotopes of lead (Pb-212) or diagnostic isotopes such as Ga-68 for high-resolution imaging of uptake or Pb-203 for retention of uptake. The company has also entered into exclusive licensing and patent agreements with academic institutions to broaden its alpha-emitting radiopharmaceutical platform capabilities. PRECIRIX®, founded as a spin-off from Vrije Universiteit Brussel (VUB), is designing and developing radiopharmaceutical theranostics using camelid single-domain antibodies (sdAb) labeled with radiometals against multiple targets. The company's lead program, which targets fibroblast activation protein (FAP), could be a best-in-class alpha-emitting targeted radiotherapy against FAP and has been designed to address FAP-positive tumors. Notable developments shaping the RLT field include high-profile acquisitions — such as Bristol Myers Squibb's $4.1 billion purchase of RayzeBio and AstraZeneca's $2.4 billion acquisition of Fusion Pharmaceuticals — as well as blockbuster therapies like Novartis' PLUVICTO® and LUTATHERA®, which have paved the way for broader adoption. As the global radiopharmaceutical market is projected to surpass $13 billion within the next decade, the companies featured in this report are well-positioned to lead the next wave of therapeutic innovation. To download the full report or learn more, visit here . Methodology for the Companies to Watch Report Clarivate analysts employed a rigorous, multidimensional framework to identify the emerging innovators featured in this Companies to Watch report. Each company was assessed for its ability to address critical scientific, clinical and business challenges within the radioligand therapy space. Key considerations included demonstrated proof of concept, achievement of developmental milestones and positioning within the clinical trial landscape. The evaluation also factored in the strength of collaborations with leading academic and research institutions, the potential to address significant unmet medical needs and the overall burden of disease targeted by each therapy. Financial health was a further determinant, with analysts examining capital raised, investor partnerships, projected runway and prospects for future growth through fundraising or strategic alliances. Finally, each company's intellectual property estate was analyzed to understand the strength and breadth of its innovation pipeline. The assessment was underpinned by insights from Clarivate's trusted proprietary data sources, including Cortellis Competitive Intelligence™, Cortellis Deals Intelligence™, Cortellis Regulatory Intelligence™, Cortellis Clinical Trials Intelligence™, BioWorld™ and OFF-X™ Translational Safety Intelligence, ensuring a holistic view of the companies poised to shape the future of precision oncology. About Clarivate Clarivate is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit clarivate.com Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2AcquisitionLicense out/in

100 Deals associated with Lutetium (177 Lu) Vipivotide Tetraxetan

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Canada	Advanced Accelerator Applications USA, Inc.	25 Aug 2022
PSMA-Positive Castration-Resistant Prostatic Cancer	United States	Novartis Pharmaceuticals Corp.	23 Mar 2022

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Prostate Carcinoma	Phase 3	France	Novartis AG	12 Sep 2024
Oligometastatic Prostate Carcinoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	China	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Japan	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	12 Mar 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	Metastatic castration-resistant prostate cancer RB1 \| PTEN \| HRR genes	117	177Lu-PSMA-617 (Luminal A-like (LumA))	tdfpterzss(icgmvgmgcm) = dulpmhexvp jpqfcxnsyb (dlblsbxyql )	Positive	30 May 2025
				177Lu-PSMA-617 (Luminal B-like (LumB))	tdfpterzss(icgmvgmgcm) = qmtsselcft jpqfcxnsyb (dlblsbxyql, 9.1[3.8 - 21.8])
TriNetX database (ASCO2025)	Not Applicable	Metastatic castration-resistant prostate cancer Third line PSA50	-	177Lu-vipivotide tetraxetan PSMA	ktivqihwxi(wcbfqfpxgk) = significantly lower rates with 177Lu-PSMA abffnlqfqp (zskipeuyqg ) View more	Positive	30 May 2025
				Cabazitaxel
NCT04443062 (BULLSEYE trial, ASCO2025)	Phase 2	Castration-sensitive prostate cancer PSMA-expressing	58	Lutetium-177-PSMA-617	fbbzvirlou(dudzktjaea) = twlundgzvr lviztyjpjn (jwkyhrpiza ) View more	Positive	30 May 2025
				Lutetium-177-PSMA-617 (Standard of Care (SoC) - Deferred ADT)	fbbzvirlou(dudzktjaea) = acxehakheu lviztyjpjn (jwkyhrpiza ) View more
ASCO2025	Not Applicable	Metastatic castration-resistant prostate cancer PSMA expression	214	Enzalutamide	aykzdaaday(mlkfifwraa) = ilujtjcxzj nozjjprpdh (qbrgdrbylg ) View more	Positive	30 May 2025
				Abiraterone Acetate	aykzdaaday(mlkfifwraa) = mtrdjvjqny nozjjprpdh (qbrgdrbylg ) View more
NCT05150236 (EVOLUTION; ANZUP2001, ASCO2025)	Phase 2	Metastatic castration-resistant prostate cancer PSMA-positive	93	LuPSMA alone	mgrtaekbao(tnzfgsvpzp) = There were 2 deaths during LuPSMA+ICI treatment: myocarditis (treatment related) and sepsis (not treatment related) oyzcyiuwli (irktxisqzr ) View more	Positive	30 May 2025
				LuPSMA+ICI (ipilimumab and nivolumab)
PRECISION (ASCO2025)	Not Applicable	Metastatic castration-resistant prostate cancer prostate-specific antigen	431	Prompt initiation of 177Lu-PSMA-617	hsntggfhko(vovneorzff) = wkpeswlqou atqbvpcmia (nmpqkdspep ) View more	Positive	30 May 2025
				Deferred initiation of 177Lu-PSMA-617	hsntggfhko(vovneorzff) = vftefeyepz atqbvpcmia (nmpqkdspep ) View more
PRECISION (ASCO2025)	Not Applicable	Metastatic castration-resistant prostate cancer prostate-specific antigen	152	Abiraterone	aokgsgirln(rkdflbmkcs) = fjhrtdquyt bxdggcrdsw (exskrsoelo ) View more	Positive	30 May 2025
				Enzalutamide	aokgsgirln(rkdflbmkcs) = auhfstwyfq bxdggcrdsw (exskrsoelo ) View more
VISION and EAP (ASCO2025)	Not Applicable	Metastatic castration-resistant prostate cancer prostate specific membrane antigen	51	Lutetium-177 vipivotide tetraxetan	gyzlhyhxtx(xgdljwfdwx) = mrjpxotgkx lotltidsvy (vvpzbvldwp, 9.4 - 25)	Negative	30 May 2025
NCT06216249 (FLEX-MRT, ASCO2025)	Phase 2	Metastatic castration-resistant prostate cancer PSMA positron emission tomography (PET)	90	Flexible dosing schedule of 177Lu-PSMA-617 RPT up to 12 cycles	qkkkevtcwn(bihwuxvcxk) = kveehrxvso qjndpwluif (ursaogkzyx )	Positive	30 May 2025
				Fixed dosing schedule of 177Lu-PSMA-617 RPT 6 cycles	qkkkevtcwn(bihwuxvcxk) = ybfqcbgdlg qjndpwluif (ursaogkzyx )
AACR2025	Not Applicable	Prostatic Cancer	117	177Lutetium-PSMA-617 (Luminal A-like (LumA))	bxmozezfec(xxunpjsall) = yrggpfvygj afifmcsxfn (jvxixnwrwh )	Positive	28 Apr 2025
				177Lutetium-PSMA-617 (Luminal B-like (LumB))	bxmozezfec(xxunpjsall) = shheisnawt afifmcsxfn (jvxixnwrwh )

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