[Translation] An international, prospective, open-label, multicenter, randomized phase III study comparing lutetium (177Lu) vipivotide tetraxetan (AAA617) versus observation for delayed castration or disease recurrence in adult men with prostate-specific membrane antigen (PSMA)-positive oligometastatic prostate cancer (OMPC)

在使用镓(68Ga)gozetotide或piflufolastat（18F）的PSMA PET检测到1-5处转移灶和常规影像学（CI）检查未显示M1病灶的PSMA阳性OMPC成人患者中，评价立体定向放射治疗（SBRT）后AAA617与观察组相比在延迟去势或疾病复发方面的疗效。

[Translation]

To evaluate the efficacy of AAA617 compared with observation after stereotactic body radiation therapy (SBRT) in delaying castration or disease recurrence in adult patients with PSMA-positive OMPC with 1-5 metastases detected by PSMA PET using gallium (68Ga)gozetotide or piflufolastat (18F) and no M1 lesions on conventional imaging (CI).

Start Date02 Jan 2025

Sponsor / Collaborator

Advanced Accelerator Applications (Italy) SRL

[+3]

NCT06145633

/ RecruitingPhase 2

Vorinostat to Augment Response to 177Lutetium-PSMA-617 in the Treatment of Patients With PSMA-Low Metastatic Castration-Resistant Prostate Cancer

This phase II trial tests how well vorinostat works in treating patients with prostate-specific membrane antigen (PSMA)-low castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) (mCRPC). Prostate cancer that has not spread to other parts of the body (localized) is typically treated through surgery or radiotherapy, which for many men is curable. Despite definitive local therapy, cancer that has come back after a period of improvement (recurrent) disease develops in 27-53% of men. Often this is detected by measurement of prostate-specific antigen (PSA) without visible evidence of metastatic disease. Lutetium Lu 177 vipivotide tetraxetan (177Lu-prostate specific membrane antigen [PSMA]-617) is a new small molecule PSMA-targeted radioactive therapy that has been approved by the Food and Drug Administration for the treatment of adult patients with PSMA-positive mCRPC who have been treated with androgen receptor inhibitors and taxane-based chemotherapy. Vorinostat is used to treat various types of cancer that does not get better, gets worse, or comes back during or after treatment with other drugs. Vorinostat is a drug which inhibits the enzyme histone deacetylase and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat and 177Lu-PSMA-617 may kill more tumor cells in in patients with PSMA-low mCRPC.

Start Date18 Sep 2024

Sponsor / Collaborator

Fred Hutchinson Cancer Center

[+3]

NCT06521775

/ Enrolling by invitationPhase 2IIT

Pilot Study Evaluating PSMA PET for Metastatic Adenoid Cystic Carcinoma

This phase II trial tests whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful for detecting therapy response in patients with adenoid cystic carcinoma (salivary gland cancer) that has spread from where it first started (primary site) to other places in the body (metastatic). The PET scan detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scan uses x-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for detecting treatment response and guiding treatment decisions in patients with metastatic adenoid cystic carcinoma.

Start Date12 Aug 2024

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Gallium GA-68 Gozetotide

100 Translational Medicine associated with Gallium GA-68 Gozetotide

100 Patents (Medical) associated with Gallium GA-68 Gozetotide

368

Literatures (Medical) associated with Gallium GA-68 Gozetotide

01 Feb 2025·European Journal of Nuclear Medicine and Molecular Imaging

Design, preclinical evaluation, and first-in-human PET study of [68Ga]Ga-PSFA-01: a PSMA/FAP heterobivalent tracer

Article

Author: Guan, Lili ; Zhang, Jinming ; Wang, Xinlin ; Zhang, Xiaoyang ; Cui, Mengchao ; Du, Jin ; Xu, Lu ; Zhang, Xiaojun ; Gao, Xi ; Pang, Hua

PURPOSE:

Prostate cancer (PCa), characterized by tumor heterogeneity, may exhibit low or absent prostate-specific membrane antigen (PSMA) expression in cancerous lesions, limiting the detection sensitivity of monospecific probes. Given that fibroblast activation protein (FAP) is frequently overexpressed in the tumor microenvironment (TME), we developed a PSMA/FAP dual-targeting tracer to address this limitation.

METHODS:

The precursor (PSFA-01) was synthesized by coupling a quinolone-based FAP-targeting scaffold and EuK with HBED-CC via amide bonds. The dual-receptor-binding affinity and cell uptake of PSFA-01 and [^natGa]Ga-PSFA-01 was evaluated in vitro. Micro-PET/CT imaging was performed on 22Rv1 and U87MG tumor-bearing mice. The feasibility of [⁶⁸Ga]Ga-PSFA-01 PET/CT in a clinical setting was evaluated in a metastatic prostate cancer patient, and the results were compared with those of [⁶⁸Ga]Ga-FAPI-04 and [⁶⁸Ga]Ga-PSMA-11 PET/CT.

RESULTS:

PSFA-01 and [^natGa]Ga-PSFA-01 showed high affinity for both FAP and PSMA proteins (K_i = 0.14-1.02 nM). On micro-PET/CT imaging, the 22Rv1 tumor uptake of [⁶⁸Ga]Ga-PSFA-01 (SUV_max = 3.89 ± 0.47) was higher than that of [⁶⁸Ga]Ga-PSMA-11 (SUV_max = 2.96 ± 0.48). The U87MG tumor uptake of [⁶⁸Ga]Ga-PSFA-01 was significantly higher (SUV_max = 7.29 ± 1.13) than [⁶⁸Ga]Ga-FAPI-04 (SUV_max = 0.28 ± 0.12), showing tumor to muscle ratio as 12.68 ± 1.93 at 1 h p.i. On clinical trial, the primary tumor and metastatic lesions were distinctly identified by [⁶⁸Ga]Ga-PSFA-01 (21 lesions), demonstrating superior performance compared to [⁶⁸Ga]Ga-FAPI-04 (3 lesions) and [⁶⁸Ga]Ga-PSMA-11 (13 lesions) in terms of lesion count and specificity.

CONCLUSIONS:

[⁶⁸Ga]Ga-PSFA-01 exhibited satisfactory PSMA and FAP dual-receptor-targeting properties both in vitro and in vivo. This study highlights the clinical feasibility of [⁶⁸Ga]Ga-PSFA-01 PET/CT for detecting metastatic tumors of prostate cancer more sensitively compared to monomeric [⁶⁸Ga]Ga-PSMA-11 and [⁶⁸Ga]Ga-FAPI-04, which also suggests that a PSMA/FAP dual-targeted radionuclide therapy could potentially overcome challenges related to tumor heterogeneity and insufficient PSMA expression in PCa.

TRIAL REGISTRATION:

Clinical trial registry NCT06387381, Registered 1 May 2024.

28 Jan 2025·ACS Nano

Preclinical and First-in-Human Study of a Compact Radionuclide Labeled Self-Assembly Nanomedicine for Chemo-Radio-Theranostics of Cancer

Article

Author: Zhu, Zhaohui ; Xiong, Hehe ; Chen, Xiaoyuan ; Shi, Changrong ; Ye, Jinmin ; Wang, Rongxi ; Qin, Yatong ; Zhang, Xinyi ; Zhou, Zijian ; Zhang, Heng ; Shen, Huaxiang ; Du, Chao ; Zhang, Qianyu ; Zhang, Jingjing

The emerging combination of chemotherapy and radionuclide therapy has been actively investigated to overcome the limitations of monotherapy and augment therapeutic efficacy. However, it remains a challenge to design a single delivery vehicle that can incorporate chemotherapeutics and radionuclides into a compact structure. Here, a chelator DOTA- or NOTA-modified Evans blue conjugated camptothecin molecule (EB-CPT) nanoprodrug was synthesized, which could self-assemble into nanoparticles due to its inherent amphiphilicity. The nanoparticles could then be effectively labeled with therapeutic radionuclide lutetium-177 (¹⁷⁷Lu) or diagnostic radionuclides gallium-68 (⁶⁸Ga)/copper-64 (⁶⁴Cu) with high radiolabeling efficiency and radiochemical stability. Impressively, a single-dose chemoradiation therapy of [¹⁷⁷Lu]Lu-DOTA-EB-CPT plus EB-CPT effectively inhibited tumor growth in HCT116 tumor-bearing mice compared to the respective individual therapeutic approach. The [⁶⁴Cu]Cu-NOTA-EB-CPT nanoparticles also exhibited excellent in vivo characteristics including favorable blood circulation properties and prolonged tumor retention in tumor-bearing mice. The safety, feasibility, tolerability, and biodistribution of [⁶⁸Ga]Ga-NOTA-EB-ss-CPT were also preliminarily characterized in a first-in-human study. This study presents a simple but robust EB-CPT radiopharmaceutical that leverages EB as an albumin binder to strike a delicate balance between enhanced tumor accumulation, safety, and diagnostic efficacy, facilitating an integrated theranostic strategy within a single molecular structure. This radionuclide-labeled EB-CPT nanomedicine presents a step toward clinical translation of the combination of chemotherapy and radiotheranostics.

02 Jan 2025·JOURNAL OF CLINICAL INVESTIGATION

68Ga-MY6349 PET/CT imaging to assess Trop2 expression in multiple types of cancer

Article

Author: Fu, Hao ; Wu, Hua ; Wang, Fan ; Sun, Long ; Shi, Jiyun ; Zeng, Ru ; Cai, Jiayu ; Gao, Hannan ; Pang, Yizhen ; Wang, Zhanxiang ; Chen, Jianhao ; Yu, Lingyu ; Zhao, Liang ; Sun, Yining ; Chen, Haojun

BACKGROUNDConsidering that trophoblast cell-surface antigen 2 (Trop2) is overexpressed in a wide range of human epithelial cancers, it presents an attractive target for diagnosis and treatment of multiple types of cancer. Herein, we have developed a Trop2-specific radiotracer, 68Ga-MY6349, and present a prospective, investigator-initiated trial to explore the clinical value of 68Ga-MY6349 PET/CT.METHODSIn this translational study, 90 patients with 15 types of cancer who underwent 68Ga-MY6349 PET/CT were enrolled prospectively. Among them, 78 patients underwent paired 68Ga-MY6349 and 18F-FDG PET/CT, and 12 patients with prostate cancer underwent paired 68Ga-MY6349 and 68Ga-PSMA-11 PET/CT.RESULTSAmong the 90 patients across 15 types of cancer, 68Ga-MY6349 uptake in tumors was generally high but heterogeneous, varying among lesions, patients, and cancer types. Trop2 expression level determined by immunohistochemistry was highly correlated with 68Ga-MY6349 uptake at primary and metastatic tumor sites. 68Ga-MY6349 PET/CT showed higher tumor uptake (quantified by maximum standardized uptake value) than 18F-FDG PET/CT in certain types of cancer, including breast (7.2 vs. 5.4, P < 0.001), prostate (9.2 vs. 3.0, P < 0.001), and thyroid cancers (8.5 vs. 3.7, P < 0.001). Compared with 68Ga-PSMA-11, 68Ga-MY6349 PET/CT exhibited comparable lesion uptake (12.2 vs. 12.5, P = 0.223) but a better tumor-to-background contrast (15.8 vs. 12.2, P < 0.001) for primary and metastatic prostate cancer, allowing visualization of more metastatic lesions.CONCLUSION68Ga-MY6349 PET/CT is a noninvasive method for comprehensively assessing Trop2 expression in tumors, which can improve diagnosis and staging for cancer patients and aid in decision making for Trop2-targeted therapies and advancing of personalized treatment.TRIAL REGISTRATIONClinicalTrials.gov NCT06188468.FUNDINGNational Natural Science Foundation of China, National Key R&D Program of China, Nuclear Energy R&D project, Fujian Research and Training Grants for Young and Middle-aged Leaders in Healthcare, Key Scientific Research Program for Young Scholars in Fujian, and Fujian Natural Science Foundation for Distinguished Young Scholars.

147

News (Medical) associated with Gallium GA-68 Gozetotide

24 Jan 2025

·www.prnewswire.com

Clarity receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer

SYDNEY, Jan. 24, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions in patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy. This milestone builds on Clarity's earlier receipt of an FTD for 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy[1]. These 2 FTDs enable the Company to accelerate the development of its comprehensive diagnostic program with this product. The FDA's FTD is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. For 64Cu-SAR-bisPSMA, it provides a number of product development advantages. The designation paves the way for a faster review process once Clarity submits its product approval applications. Additionally, it enables more frequent communication with the FDA, allowing for rapid resolution of queries during development. Furthermore, Clarity can submit completed sections of its application as they are ready, rather than waiting for the entire package to be finished before it can be lodged with the FDA. These benefits would reduce the review time needed to bring this innovative prostate cancer imaging agent to market, potentially improving diagnosis and treatment planning for patients sooner. The FTD submission highlighted several advantages of 64Cu-SAR-bisPSMA over currently approved PSMA PET agents due to the bivalent structure of bisPSMA and the longer half-life of 64Cu (12.7 hours vs. <2 hours for 18F and 68Ga). These advantages include improved diagnostic performance, flexible imaging schedule and broader availability. The data for this FTD submission was primarily focused on the results of the Phase I/II COBRA study, which assessed the safety and diagnostic performance of 64Cu-SAR-bisPSMA in detecting prostate cancer in patients with BCR of their disease who had a negative or equivocal standard of care (SOC) scan at study entry. Advantages have been shown with same-day and next-day imaging, however, the standout was next-day 64Cu-SAR-bisPSMA PET imaging, showing localised disease in up to 80% of participants and detecting lesions as small as 2 mm. This compares favourably against the current SOC PSMA PET agents, with which the detection of lesions smaller than 5 mm is challenging. The number of lesions detected by 64Cu-SAR-bisPSMA on next-day imaging almost doubled compared to same-day imaging, and 64Cu-SAR-bisPSMA was also able to identify more lesions at much earlier timepoints compared to approved PSMA PET agents. The COBRA trial paved the way for Clarity's second diagnostic registrational trial, AMPLIFY, and an investigator-initiated trial (IIT) Co-PSMA, led by Prof Louise Emmett at St Vincent's Hospital Sydney. The AMPLIFY trial will be a non-randomised, single-arm, open-label, multi-centre, Phase III diagnostic clinical trial of 64Cu-SAR-bisPSMA PET in approximately 220 participants with rising or detectable PSA after initial definitive treatment. As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer in patients with BCR. The Co-PSMA IIT will aim to build on the evidence generated so far, evaluating the diagnostic performance of 64Cu-SAR-bisPSMA in comparison to SOC 68Ga-PSMA-11 for the detection of recurrent prostate cancer lesions with curative intent. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "Receiving the second FTD for 64Cu-SAR-bisPSMA and well within the 60-day period following our application submission, reserved by the U.S. FDA for review, is yet another significant milestone in our bisPSMA program. This highlights the high unmet need for novel diagnostics in prostate cancer and the high quality of data we presented to the FDA. "The market for first-generation diagnostic PSMA PET today is approximately US$2 billion (AU$3.2 billion) in the U.S. alone, with little differentiation between products. It is expected to further grow to US$3 billion (AU$4.75 billion) by 2029. The development pipeline of new products coming to market, outside of 64Cu-SAR-bisPSMA, also offers no differentiation from the existing offering, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already. "Being able to now fast-track the development of 64Cu-SAR-bisPSMA for patients with BCR as well as for patients prior to initial definitive therapy is incredibly exciting. The news is especially timely as we are actively preparing to commence recruitment for our second registrational trial, AMPLIFY, in the coming months. The designation will allow us to work closely with the FDA to facilitate the development process and accelerate the approval of what could become a best-in-class diagnostic. "The dual targeting structure of bisPSMA enables increased uptake and retention of the product in the lesions, while the longer half-life of copper-64 provides greater flexibility with imaging scheduling, including next-day imaging (something that gallium-68 and fluorine-18 based products cannot support). When combined, these features make 64Cu-SAR-bisPSMA stand out from its competitors who are known to have issues with sensitivity. We have seen 2-3 times higher uptake in prostate cancer lesions and the identification of more lesions using 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 in pre-prostatectomy patients in our PROPELLER study. The COBRA trial results showed great diagnostic performance in the BCR setting, with lesions identified by 64Cu-SAR-bisPSMA in the 2-mm range and visualised many months before SOC PSMA PET agents are able detect them. "Not only are we developing a product that may have improved diagnostic performance compared to SOC PSMA PET agents, but the longer half-life of copper-64 also enables a longer shelf-life of 64Cu-SAR-bisPSMA than currently used diagnostic radiopharmaceuticals, allowing for centralised manufacture and wider distribution. These attributes have the potential to reduce disparities in prostate cancer care and ensure that most patients, regardless of geographic location, can benefit from the latest advances in diagnostic technology. "This designation highlights the unique opportunity for 64Cu-SAR-bisPSMA in this very large market by addressing the limitations of the current-generation diagnostic radiopharmaceuticals and providing patients with prostate cancer with a more accurate diagnosis leading to more optimal treatment options. As such, we are fully committed to advancing the development of this best-in-class product to address the critical need for more accurate and accessible diagnostic tools in prostate cancer management." About SAR-bisPSMA SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy. 64Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of 64Cu-SAR-bisPSMA has not been assessed by health authorities such as the U.S. FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. Among 82 patients who received 64Cu-SAR-bisPSMA in PROPELLER and COBRA, 2 adverse reactions were reported in 2 participants (mild occasional metallic taste and moderate worsening of type II diabetes, both resolved)[2],[3]. About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[4]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the U.S. and around 35,770 deaths from the disease[5]. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers in children and adults. This announcement has been authorised for release by the Executive Chairperson. SOURCE Clarity Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Fast TrackClinical Result

16 Jan 2025

·www.pharmaceutical-technology.com

JP Morgan 2025: Radiopharmaceuticals M&A fuels Telix’s busy year

With acquisitions across the supply chain and fresh approvals expected in 2025, Telix are entrenching their position in the radiopharmaceuticals market. Love Employee/ Getty Images Following a year thick with acquisitions across the radiopharmaceutical supply chain, Telix Pharmaceuticals has announced a 55% year-on-year revenue increase in 2024. CEO Christian Behrenbruch described the Australian company’s success in a presentation at the 2025 JP Morgan Healthcare Conference on 15 January in San Francisco. After a flurry of acquisitions, Behrenbruch announced Telix superseded its 2024 revenue guidance, generating $517m as its stock continues to rise. In 2025, Behrenbruch said Telix expects to launch three new products to the US market pending US Food and Drug Administration (FDA) approval. These include Gozellix (TLX007-CDx) for PSMA imaging of prostate cancer and Pixclara (TLX101-CDx) for glioblastoma imaging with Prescription Drug User Fee Act (PDUFA) dates set for 24 March and 26 April, respectively, as well as Zircaix (TLX250-CDx) for kidney cancer imaging for which a PDUFA date is expected around August to September. Nonetheless, the past year was not full of successes for Telix. In January, the company announced plans for a US initial public offering (IPO), but in June it withdrew its bid , with executives blaming market conditions at the time. Still, at the same time, the company went on an acquisition spree, starting with Canadian isotope producer ARTMS in March for $575m, IsoTherapeutics in April for $8.1m plus milestone payments, and QSAM Biosciences in May for 123.1m, and also purchased RLS Radiopharmacies in September for $230m. With these acquisitions, Telix has built a network of isotope production and distribution facilities across the US and R&D operations in US and Canada. Telix also plans to expand the approval of its lead product Illuccix (TLX591-CDx) for prostate cancer imaging into the EU, UK, and Brazil, with Phase III bridging studies completed in China and underway in Japan. Approved by the FDA in December 2021, Illuccix generated $357.9m in H1 2024 global sales as per a Telix report, accounting for the majority of the company’s revenue. Behrenbruch stated Telix will continue to maintain focus on beta-emitting assets like Illuccix in its pipeline, but that the company is also investing in several alpha-emitters as part of its next-generation isotope platform. Telix’s most advanced clinical asset is TLX591 (Lu-177 rosopatamab tetraxetan), a beta-emitting antibody conjugate being studied in the Phase III ProSTACT GLOBAL trial (NCT04876651) to treat castration-resistant prostate cancer. Interim data from part 1 of the trial is expected in late H1 2025, according to Behrenbruch. Alongside TLX591, Behrenbruch said Telix expects initiate pivotal trials for Zircaix in clear cell renal carcinoma and Pixclara in recurring glioblastoma in 2025.

Drug ApprovalPhase 3AcquisitionClinical Result

13 Jan 2025

·www.globenewswire.com

Telix Exceeds FY24 Guidance with US$142M Q4 Revenue

MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 December 2024 (Q4 2024). Sustained revenue growth Q4 2024 unaudited revenue of approximately US$142 million (AU$218 million)1, represents an increase of 46% over the prior year corresponding quarter (Q4 2023: US$97 million or AU$148 million) and a quarter-over-quarter increase of 5% (Q3 2024: US$135 million or AU$201 million).Telix’s revenue is currently generated predominantly from sales of Illuccix®, its diagnostic radiopharmaceutical for prostate cancer PET2 imaging. Full year guidance exceeded Total FY2024 unaudited revenue is approximately US$517 million (AU$783 million) exceeding previously stated guidance of US$490 million to US$510 million (AU$745 million to AU$776 million), representing a 55% increase over FY2023.FY2024 investment into research and development (R&D) remains in line with guidance, funded by earnings generated from product sales.The Company intends to provide FY2025 guidance when it reports audited FY2024 annual results on 20 February 2025. Q4 2024 business update Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer, Telix, said, “This has been another great quarter of commercial performance. Strong sales of Illuccix have led Telix to close out the year with revenue above guidance, while significantly progressing our strategic priorities. Boosting our balance sheet and the Nasdaq listing were major corporate milestones. The acquisition of FAP-targeting assets is a major addition to our superb product pipeline. We are well-positioned for significant expansion, including planned launches of multiple imaging products in key markets and advancing late-stage therapeutic assets into pivotal trials. 2025 is shaping up to be transformative year for Telix.” Therapeutics Business Prostate cancer therapy candidate, TLX591 (177Lu-rosapatamab): During Q4 2024 Telix progressed ProstACT GLOBAL, the registrational clinical trial for Telix’s lead clinical therapeutic asset with first interim read out expected in H1 2025. Kidney cancer therapy candidate, TLX250 (177Lu-girentuximab): The Company was granted a pre-investigational new drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in Q4 2024, to discuss a proposed Telix-sponsored pivotal trial of TLX250. Glioblastoma therapy candidate, TLX101 (131I-iodofalan, or 131I-IPA): During Q4 2024, the Company held a pre-IND meeting with the FDA to discuss the design of a pivotal trial for TLX101. Based on positive feedback from the meeting, Telix will move forward with an IND submission in H1 2025. Fibroblast Activation Protein (FAP) targeting therapy candidate, TLX400: Telix entered into asset purchase and exclusive worldwide in-license agreements for a suite of clinically validated assets targeting FAP. FAP is one of the most promising pan-cancer targets, with an initial focus on bladder cancer rounding out Telix’s leading urology theranostics franchise. Proprietary engineered antibody platform and pipeline: Today, Telix announced it has entered into a transaction with ImaginAb Inc. to acquire a groundbreaking platform technology and drug discovery capability, along with a pipeline of next-generation biologic-based therapeutic candidates with significant potential to deliver future innovation in radiopharmaceuticals3. Precision Medicine Business Kidney cancer imaging, TLX250-CDx (Zircaix®4, 89Zr-girentuximab): Telix submitted a Biologics License Application (BLA) for its renal cancer imaging candidate on 27 December 2024 and continues to target a U.S. commercial launch in H2 20255. Brain cancer imaging, TLX101-CDx, (Pixclara®4, 18F-floretyrosine or 18F-FET): The FDA formally accepted Telix’s New Drug Application (NDA), granted a Priority Review and provided a PDUFA6 goal date of 26 April 2025. Illuccix® global regulatory submissions: The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, or BfArM) is expected to provide its decision on the Company’s EU marketing authorization application on 15 January 2025. In the United Kingdom (UK), the Company has responded to all queries with no substantive issues raised. The UK regulator (the Medicines and Healthcare products Regulatory Agency - MHRA) is experiencing significant administrative delays but an approval decision is expected this month. The Brazilian Health Regulatory Agency (ANVISA) is expected to provide a decision imminently after protracted administrative delays also unrelated to Telix’s marketing authorization application. MedTech partnership with Subtle Medical: Telix has concluded a partnership with California-based Subtle Medical, Inc. for artificial intelligence (AI)-powered PET imaging with Illuccix7. This technology enhances scanning workflow, increasing scanner throughput and capacity. Scintimun®: Today, Telix announced that it has entered into an agreement with Curium Pharma for the transfer of marketing and distribution rights for Scintimun® (99mTc-besilesomab, also known as TLX66-CDx)8. Scintimun is approved in 33 countries to image infection (osteomyelitis), with significant clinical indication expansion and theranostic potential. Telix Manufacturing Solutions (TMS) RLS (USA) Inc acquisition: During Q4 2024, Telix progressed integration planning and expects to close the transaction in the first quarter of 20259. Brussels South production facility buildout: Telix completed the installation of two new cyclotrons at its facility in Brussels South, Belgium, facilitating the production of radioisotopes and patient doses on-site from 202510. Formal Good Manufacturing Practice (GMP) accreditation for the facility is expected imminently. Corporate milestones On 14 November 2024, Telix American Depository Shares (ADSs) commenced trading on the Nasdaq Global Select Market (Nasdaq) under the symbol ‘TLX’11. Telix continues to maintain its primary listing on the Australian Securities Exchange (ASX). 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, Europe (Belgium and Switzerland), Canada, 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). Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the FDA12, the Australian Therapeutic Goods Administration (TGA)13, and Health Canada14. No other Telix product has received a marketing authorization in any jurisdiction. 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 X and LinkedIn. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. 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 registration statement 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 commercialisation 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 benefits of Telix’s acquisitions; 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. The Telix Pharmaceuticals®, Illuccix®, Gozellix®4, Pixclara®4, Scintimun® and Zircaix®4 names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. ___________________________________ 1 Total revenue for Q4 2024 and year-to-date (FY2024) is provided on an unaudited basis. Conversion to AU$ is at an average exchange rate realized during Q4 2024 of AU$1 = US$0.6512 Positron emission tomography.3 Telix ASX disclosure 13 January 2025.4 Brand name subject to final regulatory approval.5 The 27 December 2024 BLA submission to the FDA is intended to remediate a filing issue with the initial BLA submission from June 2024. See Telix ASX disclosures 31 July 2024 and 30 December 2024.6 Prescription Drug User Fee Act.7 Telix media release 30 October 2024.8 Telix media release 13 January 2025.9 Telix ASX disclosure 23 September 2024.10 Telix media release 19 December 2024.11 Telix ASX disclosure 14 November 2024.12 Telix ASX disclosure 20 December 2021.13 Telix ASX disclosure 2 November 2021.14 Telix ASX disclosure 14 October 2022.

Drug ApprovalLicense out/inAcquisition

100 Deals associated with Gallium GA-68 Gozetotide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	V09	DB16019

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	EU	Novartis Europharm Ltd.	09 Dec 2022
Metastatic castration-resistant prostate cancer	IS	Novartis Europharm Ltd.	09 Dec 2022
Metastatic castration-resistant prostate cancer	LI	Novartis Europharm Ltd.	09 Dec 2022
Metastatic castration-resistant prostate cancer	NO	Novartis Europharm Ltd.	09 Dec 2022
Metastatic Prostate Carcinoma	AU	Telix Pharmaceuticals Ltd.	10 Nov 2021
Prostatic Cancer	US	University of California, Los Angeles	01 Dec 2020
Prostatic Cancer	US	The University of California, San Francisco	01 Dec 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
PSMA-Positive Prostatic Cancer	NDA/BLA	CN	Beijing Novartis Pharma Co. Ltd.	13 Nov 2024
PSMA-Positive Prostatic Cancer	NDA/BLA	CN	Advanced Accelerator Applications (Italy) SRL	13 Nov 2024
PSMA-Positive Prostatic Cancer	NDA/BLA	CN	Novartis Pharma Schweiz AG	13 Nov 2024
Non-metastatic prostate cancer	Phase 3	CN	Telix Pharmaceuticals Ltd.	19 Jul 2023
Non-metastatic prostate cancer	Phase 3	CN	Grand Pharmaceutical (China) Co., Ltd.	19 Jul 2023
Salivary Gland Adenoma, Pleomorphic	Phase 3	US	Stanford University	20 May 2017
Recurrent Prostate Carcinoma	Phase 3	US	Jonsson Comprehensive Cancer Center	15 Sep 2016
Adenocarcinoma of prostate	Phase 3	US	National Cancer Institute	18 Apr 2016
Adenoid Cystic Carcinoma	Phase 2	US	Mayo Clinic	12 Aug 2024
Glioma	Phase 2	US	Mayo Clinic	26 Jul 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04716725 (CTgov)	Phase 2	Metastatic Prostate Carcinoma \| Metastatic castration-resistant prostate cancer	15	Positron Emission Tomography (PET)+68Ga-PSMA-11	hgcyujtsks(ttzflgkakr) = efxxmbnmoa sgzesvnhos (aqctykvwxa, pccrhamuhi - gskdispkpd) View more	-	16 Oct 2024
MORE-PSMA (EANM2024)	Not Applicable	Hepatocellular Carcinoma PSMA-	33	68Ga-PSMA-11 (ceMRI with hepatospecific-contrast)	dlvychlkid(hpcpvawbze) = dazlkxnzuq gpaakjziza (mcakvscdbg )	Positive	27 Sep 2024
EANM2024	Not Applicable	PSMA	58	Ga68-PSMAGa⁶⁸-PSMA (Ga68-PSMA PET/CT)	blqjkpbyyp(krkpvqhteb) = zvyqmvuaob qqwwpotfxu (tkwipqylfi ) View more	Positive	27 Sep 2024
EANM2024	Not Applicable	PSMA	6	[68Ga]-PSMA-11 (HCC patients)	qjddtmyskf(kheguexdql) = mbciioxque jkbqgragfg (jpxmgflaqq ) View more	-	27 Sep 2024
EANM2024	Not Applicable	PSMA	6	[68Ga]-PSMA-11 (Normal liver tissue)	qjddtmyskf(kheguexdql) = zpgmljvtac jkbqgragfg (jpxmgflaqq ) View more	-	27 Sep 2024
EANM2024	Not Applicable	Prostatic Cancer PSA \| Gleason Score \| MSKCC nomogram	103	GA-68PSMAGa-68 PSMA (Patients with Ga-68 PSMA PET/CT)	pydbrqdsou(iszexvtvny) = bukgszaowg fexguvguyc (gjuxyohjqb ) View more	-	27 Sep 2024
NCT04976257 (Pubmed \| Radiology)	Early Phase 1	Adenocarcinoma of prostate prostate-specific membrane antigen (PSMA)	5	Intravenous PSMA-11 infusion	nubukriogk(acugkdqftf) = rxxnimcpzn rftkuvqazi (ydtpjnfotr, 69 - 622)	Positive	01 Aug 2024
NCT04976257 (Pubmed \| Radiology)	Early Phase 1		5	Selective prostatic arterial PSMA-11 infusion	nubukriogk(acugkdqftf) = makiyixfmt rftkuvqazi (ydtpjnfotr, 8353 - 20025)	Positive	01 Aug 2024
NCT03389451 (CTgov)	Phase 2/3	Recurrent Prostate Carcinoma \| Castration-Resistant Prostatic Cancer \| Metastatic Prostate Carcinoma	30	Ga-68 PSMA-HBED-CC PET	sdpzkkhqgi(ilfoazueel) = nozkcdptfd shfjnihgao (amtoluxlzb, lgwcaksihh - eiouuhuwju) View more	-	28 Jun 2024
SNMMI2024	Not Applicable	PSMA-Positive Tumor	-	18F-DCFPyL PET/CT	mybjewgfen(nipyadtdmd) = aqyvsihvls inhqqnanyl (jffolfsrmr, 82% - 100%)	-	09 Jun 2024
SNMMI2024	Not Applicable	Prostatic Cancer	-	Curative Intent Radiotherapy (RT)	zptquzcdwm(vmxodblgbv) = blodcfvwyu dazhuchvxg (lsvowqwdgo )	-	09 Jun 2024
NCT04086966 (CTgov)	Phase 1	Metastatic Prostate Carcinoma	10	[68Ga]PSMA-PET/MRI or PET/CT	zkjshouolo(bhgdwzkxxu) = eazwpqcriq jpmytqgflh (ghosertveq, bnrrpgyiir - qnahygqghp) View more	-	26 Apr 2024

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