[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

316

Literatures (Medical) associated with Gallium GA-68 Gozetotide

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

Comparison of clinical performance between late and standard total-body [68 Ga]Ga-PSMA-11 in biochemical recurrent prostate cancer

Article

Author: Chen, Ruohua ; Chen, Qiaochu ; Xu, Lian ; Huang, Gang ; Li, Lianghua ; Zhao, Haitao ; Dong, Liang ; Liu, Jianjun

BACKGROUND AND PURPOSE:

Enhanced lesion detection in prostate cancer is observed with late [⁶⁸ Ga]Ga-PSMA-11 PET/CT imaging compared to standard [⁶⁸ Ga]Ga-PSMA-11 PET/CT imaging (50-100 min p.i.). However, the poor image quality of late imaging using short axial field of view (SAFOV) PET/CT has hindered its sole clinical adoption. Conversely, the image quality of late imaging with a long axial field of view (LAFOV) [⁶⁸ Ga]Ga-PSMA-11 PET/CT fulfills clinical diagnostic requirements. Nonetheless, the diagnostic efficacy of late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT with forced diuresis and its impact on treatment decisions, compared to standard LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT, remains unclear. This study aims to compare the rate of PET positivity between late and standard LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT and to evaluate the influence of late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT with forced diuresis on treatment decisions relative to standard scans.

METHODS:

From January 2021 to April 2024, 127 patients with biochemical recurrence of prostate cancer post-radical prostatectomy were enrolled to undergo both standard and late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT scans at Shanghai Renji Hospital. We compared the rate of PET positivity between the two modalities at the patient level and across different anatomical regions. We assessed the added diagnostic value of late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT and its impact on modifying patient treatment plans.

RESULTS:

The image quality of late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT with forced diuresis in all patients met clinical diagnostic requirements. The rate of PET positivity of late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT with forced diuresis were significantly higher than those of standard LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT (80.31% [102/127] vs. 65.35% [83/127]; P < 0.001). Late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT demonstrated higher lesion SUVmax (16.69 ± 16.42 vs. 11.91 ± 10.72, P < 0.001) and TBR (6.26 ± 7.21 vs. 3.44 ± 3.57, P < 0.001) compared to standard LAFOV scans. Additionally, 14.17% (18/127) of patients experienced changes in their treatment regimen due to the superior detection capabilities of late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT with forced diuresis compared to the standard scan.

CONCLUSIONS:

The rate of PET positivity of late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT with forced diuresis compared to standard LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT highlight its potential as a valuable diagnostic tool for biochemically recurrent prostate cancer. This study paves the way for using late LAFOV [⁶⁸ Ga]Ga-PSMA-11 PET/CT with forced diuresis for prostate cancer imaging in daily clinical practice, facilitating more accurate and timely diagnoses.

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 ; Zhang, Xiaoyang ; Wang, Xinlin ; 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.

01 Dec 2024·PROSTATE

Evaluation of online teaching modules for PSMA PET interpretation

Article

Author: Rowe, Steven P. ; Oldan, Jorge D. ; Schroeder, Jennifer A.

Abstract:

Purpose:

The proliferation of US FDA‐approved prostate‐specific membrane antigen (PSMA)‐targeted positron emission tomography (PET) imaging agents as a means to evaluate prostate cancer patients, and the expanding knowledge of interpretive pitfalls, has led to the generation of multiple online training modules geared toward the reading of each individual agent, each taking different approaches to criteria for interpretation, which may contribute to the variability of reporting in clinical practice.

Materials and Methods:

The websites of the marketers of each FDA‐approved agent [68Ga‐PSMA‐11 (Illuccix; Telix Pharmaceuticals), 68Ga‐PSMA‐11 (Locametz; Novartis Pharmaceuticals), 18F‐rh‐PSMA‐7.3 (Posluma; Blue Earth Diagnostics)], and the website of the Society of Nuclear Medicine and Molecular Imaging [18F‐DCFPyL (Pylarify)] were examined. All information pertaining to reader training, including videos, PDFs, and PowerPoint presentations, were reviewed.

Results:

Videos from each module covered interpretive approach and pitfalls and ranged in length from a total of 20 min up to 315 min. Each module provided a different approach to PSMA PET scan findings, and on a different number and breadth of interpretive tips and pitfalls (a total of approximately 12–30 in all).

Conclusions:

Each of the four PSMA PET reader training modules covered important interpretive pitfalls. The lengths of the video portions of each module varied considerably, suggesting variable investments in time necessary to complete each module. The differences in the modules could contribute to inconsistency among readers depending on which module(s) they may have completed and which radiotracer(s) they are using.

150

News (Medical) associated with Gallium GA-68 Gozetotide

20 Feb 2025

·www.prnewswire.com

Telix 2024 Full Year Results: Record Financial Performance and Investment in Future Growth, FY2025 Guidance of up to $1.23 Billion

MELBOURNE, Australia and INDIANAPOLIS, Ind., Feb. 20, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces its financial results for the year ended 31 December 2024. All figures are in AU$ unless stated otherwise. FY2024 highlights Total revenue, driven primarily from sales of Illuccix® of $783.2 million, up by 56%1 from $502.5 million in 2023, beating full year guidance2. Second year of profitable growth, delivered in a period of investment, including: R&D investment of $194.6 million, in line with guidance, with a focus on late-stage assets. Expanded global supply chain and product delivery infrastructure, including acquisitions of ARTMS, Inc. and IsoTherapeutics Group, LLC, and expansion of Telix Manufacturing Solutions' Brussels South facility, resulting in an incremental increase of $15.8 million in manufacturing and distribution investment. Adjusted EBITDA of $99.3 million, up by 70%, demonstrating strong underlying growth3. Telix continued to deliver on its growth strategy. The Company's key achievements, aligned to its strategic pillars: Grow precision medicine: Prepared for launch of three new products TLX007-CDx (Gozellix®), TLX101-CDx (Pixclara®) and TLX250-CDx (Zircaix®)4 in 2025 while continuing to increase sales and market share for Illuccix®. Deliver late-stage therapeutics: Expanded ProstACT GLOBAL Phase 3 prostate cancer therapy trial recruitment in the U.S. and continued to advance therapeutic trials for the brain and kidney cancer programs. Build next generation pipeline: Delivered clinical proof-of-concept for first alpha therapy candidate in prostate cancer (TLX592) and added depth to urology franchise with acquisition of FAP5-targeting theranostic. Expand global delivery infrastructure: Completed acquisitions of ARTMS, IsoTherapeutics and RLS (USA), Inc. (RLS)6 and expanded Brussels South facility, in preparation to commence GMP7 production in 2025. For a full list of operational achievements, please refer to the Telix 2024 Annual Report. Commentary Group CEO, Dr. Christian Behrenbruch, commented on the result: "2024 has been an extraordinary year for Telix. We generated strong financial growth while investing for the future. The Precision Medicine business is poised for step-change growth with three commercial product launches planned for this year in the U.S. and the European rollout of Illuccix. We have a deep therapeutic pipeline with multiple assets moving into pivotal trials, and we are building out the infrastructure to ensure we can deliver our products to patients around the world. We see 2025 as a year of significant growth and evolution for Telix in terms of international business, multiple product launches and the integration of key infrastructure that will further deliver on our mission to ensure global patient access." Further details on the Company's results can be found in the Appendix 4E, investor presentation, and 2024 Annual Report lodged with the ASX and also available on the Company's website. Guidance Telix provides FY2025 revenue guidance of $1.18 billion to $1.23 billion (US$770 million to US$800 million1). This guidance includes revenue from Illuccix (in jurisdictions with a marketing authorization)2 and 11 months of revenue from RLS (and excluding RLS revenue generated from Illuccix). Guidance does not reflect revenue for products that have not yet received a marketing authorization (for example, Gozellix, Pixclara and Zircaix3). Telix has also provided R&D expenditure guidance, expecting an increased investment range of 20% to 25% compared to FY2024. lnvestor call An investor webcast will be held at 9.00am AEDT on Friday 21 February 2025 (5.00pm EST, Thursday 20 February 2025). Participants can register for the webcast and find audio call details at the following link: diamondpass/10044775-kmnuu.html 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, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX). Visit for further information about Telix, including details of the latest share price, announcements made to the ASX, 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. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] Guidance Disclaimer The stated revenue guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are listed below. Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix's ability to protect its patents and other intellectual property. This announcement has been authorized for release by the Telix Pharmaceuticals Limited Board of Directors 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; 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. Telix uses various non-IFRS information to reflect its underlying performance. For further information, the reconciliation of non-IFRS financial information to Telix's statutory measures, reasons for usefulness and calculation methodology, please refer to the Alternative performance measures section in Telix's Annual Report. ©2025 Telix Pharmaceuticals Limited. The 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. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionFinancial StatementPhase 3

12 Feb 2025

·www.prnewswire.com

Illuccix® Approved in the United Kingdom

MELBOURNE, Australia, Feb. 12, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection). Illuccix is indicated in the UK for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, using PET. PSMA-PET imaging[2] represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT[3] scan) as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP)[4]. Gary Cook, MD, Professor of Molecular Imaging at Kings College London School of Biomedical Engineering & Imaging Sciences, commented, "PSMA-PET supply shortages in the UK and Europe have escalated over the past 12 months as demand increases, which has led to delays for men in urgent need of a scan to direct clinical management. It is great news that Telix can now help address this unmet need and improve equity of access in the UK through their Illuccix imaging agent and network distribution model." Raphaël Ortiz, Chief Executive Officer, Telix International added, "PSMA-PET imaging is one of the most important developments in prostate cancer detection in recent years and we are delighted that we can now bring Illuccix to physicians and their patients across the UK. A key advantage of Illuccix is that the radioisotope (gallium-68) can be produced using a generator locally, taking just a few minutes with minimal equipment. Reliable service delivery combined with greater scheduling flexibility, including in non-metropolitan locations, will benefit patients, physicians and clinical sites in the UK." Illuccix will be made available in the UK through Telix's exclusive distribution partner, Xiel Limited, a specialist distributor of nuclear medicine, radiotherapy and diagnostic radiology technologies across the UK and Ireland. To order or enquire about Illuccix availability, UK healthcare professionals can email: [email protected] or call +44 (0)1749 372217. About Illuccix®  Telix's prostate 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 U.S. Food and Drug Administration (FDA)[5], by the Australian Therapeutic Goods Administration (TGA)[6], by Health Canada[7], by the Danish Medicines Agency[8], and by the UK MHRA. Illuccix is currently in national approval review in 19 European countries following a positive decentralized procedure (DCP) opinion by BfArM[9]. 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, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX). Telix's osteomyelitis (bone infection) imaging agent, technetium-99m (99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix's miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction. Visit 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. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] 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; 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®, 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. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

24 Jan 2025

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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

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
PSMA-Positive Prostatic Cancer	GB	Telix Pharmaceuticals Ltd.	12 Feb 2025
PSMA-Positive Castration-Resistant Prostatic Cancer	EU	Novartis Europharm Ltd.	09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer	IS	Novartis Europharm Ltd.	09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer	LI	Novartis Europharm Ltd.	09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer	NO	Novartis Europharm Ltd.	09 Dec 2022
Metastatic Prostate Carcinoma	AU	Telix Pharmaceuticals Ltd.	10 Nov 2021
Prostatic Cancer	US	The University of California, San Francisco	01 Dec 2020
Prostatic Cancer	US	University of California, Los Angeles	01 Dec 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
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
Metastatic castration-resistant prostate cancer	Phase 3	US	Mayo Clinic	09 May 2022
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
WHO Grade III Mixed Glioma	Phase 2	US	Mayo Clinic	26 Jul 2024
Advanced Hepatocellular Carcinoma	Phase 2	US	Mayo Clinic	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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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	oqtrfoucwu(rzgxktgenf) = vwarkwadyd bfqnupfjrm (zeggrxqdyi, mxfhwfeoeq - pvhwjmxlox) View more	-	16 Oct 2024
EANM2024	Not Applicable	PSMA	58	Ga68-PSMAGa⁶⁸-PSMA (Ga68-PSMA PET/CT)	yiremidges(eluvbapgeu) = eglhvmhgbb vixkuwcgap (fwghzjlyro ) View more	Positive	27 Sep 2024
EANM2024	Not Applicable	PSMA	6	[68Ga]-PSMA-11 (HCC patients)	ehmarixlgf(xllfmunlmf) = hqfqytqcjc djyhabhxej (kasfelvoqw ) View more	-	27 Sep 2024
EANM2024	Not Applicable	PSMA	6	[68Ga]-PSMA-11 (Normal liver tissue)	ehmarixlgf(xllfmunlmf) = wbfihkmmcz djyhabhxej (kasfelvoqw ) View more	-	27 Sep 2024
MORE-PSMA (EANM2024)	Not Applicable	Hepatocellular Carcinoma PSMA-	33	68Ga-PSMA-11 (ceMRI with hepatospecific-contrast)	lcesjqzjil(hjadaanaus) = xuqesqsqem oskvuenveq (bzfvncuabh )	Positive	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)	ejqzlfwure(mhqgwhjfuv) = isqazlkszh bamykafwrm (bmqwrxbsoq ) View more	-	27 Sep 2024
NCT04976257 (Pubmed \| Radiology)	Early Phase 1	Adenocarcinoma of prostate prostate-specific membrane antigen (PSMA)	5	Intravenous PSMA-11 infusion	bgynxmpvld(scmpdqelwz) = erqtbrhbdd bvfxffpyip (hidrwpllie, 69 - 622)	Positive	01 Aug 2024
NCT04976257 (Pubmed \| Radiology)	Early Phase 1		5	Selective prostatic arterial PSMA-11 infusion	bgynxmpvld(scmpdqelwz) = echnebqldt bvfxffpyip (hidrwpllie, 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	tiyhluefif(qreheihefx) = stmajditrk wrlcwgqwdf (uedenudlcf, wgsoertokf - mbgjpmlzya) View more	-	28 Jun 2024
SNMMI2024	Not Applicable	Prostatic Cancer	-	Curative Intent Radiotherapy (RT)	nbwlzhjqmu(dpnssnppwj) = kntotoijsg yhclgiwvod (vlihfzlwqs )	-	09 Jun 2024
SNMMI2024	Not Applicable	PSMA-Positive Tumor	-	18F-DCFPyL PET/CT	ielqldgmlp(rtrsecgolz) = jiinyaoigy vhmoocpild (avvtjyndex, 82% - 100%)	-	09 Jun 2024
NCT04086966 (CTgov)	Phase 1	Metastatic Prostate Carcinoma	10	[68Ga]PSMA-PET/MRI or PET/CT	klajclvetm(dosdtrvxnf) = opnwlwreec vduzrrrgxq (yhwjhdklul, uimacbjyda - gbfqwhopcz) View more	-	26 Apr 2024

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