CAIX

MELBOURNE, Australia, Oct. 16, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces thirteen abstract presentations featuring the Company's ongoing theranostic development, medical technologies (MedTech), and research and innovation (R&I) programs at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Hamburg from 19 – 23 October 2024. Telix's extensive theranostic pipeline will be showcased in presentations covering: TLX250-CDx (Zircaix®[1], 89Zr-girentuximab) kidney cancer imaging, including first real-world clinical experience; TLX101 (131I-iodofalan or 131I-IPA) glioblastoma therapy; TLX66 (90Y-besilesomab) bone marrow conditioning therapy; TLX252 (225Ac-girentuximab) carbonic anhydrase IX (CAIX)-targeted alpha therapy; and SENSEI®, Lightpoint's robotic-assisted gamma probe. Dr. David N. Cade, Telix Group Chief Medical Officer, said, "We are pleased to be able to so comprehensively showcase our pipeline at EANM – the largest gathering of nuclear medicine professionals worldwide – with a sponsored symposium, and abstracts accepted across Telix's late-stage theranostic programs in kidney and brain cancers, and in bone marrow conditioning. As in previous years, it is an honour for us to support the EANM Sanjiv Sam Gambhir Young Investigator Award. This is an exciting opportunity for a junior physician or scientist to further develop their career in radiopharmaceuticals, in memory of an extraordinary man and an inspiring educator." We look forward to seeing delegates at Telix's booth in Hall H, Stand H29 to discuss Telix's industry leading theranostic pipeline in urologic oncology (prostate, kidney and bladder cancers), neuro-oncology (glioma), musculoskeletal oncology (sarcoma) and hematology, our associated medical devices, and opportunities for collaboration. EANM presentation details are as follows: Sponsored Symposium: Does size matter in targeted radionuclide therapies? Chairperson: Professor Viktor Grünwald, University Hospital Essen, Essen, Germany. Why size matters: The relative benefits of antibodies vs. small molecules in oncology Prof. Arturo Chiti, IRCCS San Raffaele Hospital, Milan, Italy When small may be smart: The role of small molecules in neuro-oncology Prof. Nathalie Albert, Ludwig-Maximilian's-University of Munich, Munich, Germany Where big may be best: The power of antibodies in onco-hematology Prof. Stefano Fanti, University of Bologna, Bologna, Italy How size will shape the future: The choice between antibodies and small molecules in uro-oncology Prof. Karolien Goffin, University Hospital Leuven, Leuven, Belgium Date & Time: Sunday, 20 October, 2024, 13:15 – 14:45 CEST Location: Hall G1, Congress Center Hamburg Abstract presentations Title: Unravelling radiobiological and immunological mechanisms driving effective CAIX-TRT and ICI combination therapy Presenter: S. Kleinendorst, RadboudUMC, Netherlands Date and Time: 20-Oct-24, 08:00 – 09:30 Session: Cutting Edge Science Track - TROP Session: Dosimetry Committee: Preclinic and Radiobiology Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-022 Title: Accuracy of personalised single time point dosimetry for bone marrow and liver dosimetry in TLX66 (90Y-Anti CD66) radioimmunotherapy Presenter: A. Nautiyal, University Hospital Southampton, United Kingdom Date and Time: 20-Oct-24, 15:00 – 16:30 Session: Cutting Edge Science Track - TROP Session: Dosimetry Committee: Dosimetry: A Question of Time Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-158 Title: Tumour margin thickness inference for 99mTc radio-guided surgery using internal conversion electrons Presenter: J. Moo, Telix Date and Time: 21-Oct-24, 08:00 – 09:30 Session: Cutting Edge Science Track - TROP Session: Physics Committee: Data Corrections / Image Enhancement Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-289 Title: Radiation protection considerations with TLX250-CDx (89Zr-girentuximab) PET/CT experience in France Presenter: C. Morgat, Department of Nuclear Medicine, University Hospital of Bordeaux, France Date and Time: 21-Oct-24, 15:00 – 16:30 Session: TROP Session: Radiation Protection Committee: Radiation Protection in Diagnostic Imaging Procedures Format: Oral Location: Hall Y1-Y3 Presentation ID: OP-452 Title: Correlation of tracer uptake in sentinel lymph nodes as measured on SPECT/CT and during intraoperative gamma tracing with the SENSEI drop in gamma probe: the UZ Leuven experience Presenter: M. Manley, Nuclear Medicine, University Hospitals Leuven, Belgium Date and Time: 22-Oct-24, 08:00 – 09:30 Session: Cutting Edge Science Track – TROP Session: Physics Committee: SPECT/CT Quantification Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-543 Title: Development of 161Tb-DOTA-HYNIC-panPSMA for targeted radionuclide therapy of prostate Cancer Presenter: C. Morgat, Department of Nuclear Medicine, University Hospital of Bordeaux, France Date and Time: 22-Oct-24, 08:00 – 09:30 Session: M2M Track - TROP Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation Format: Oral Location: Hall X1-X4 Presentation ID: OP-532 Title: Feasibility and tolerability of TLX101 (¹³¹I-IPA) monotherapy in progressive and recurrent high grade gliomas; an ongoing single institution case series Presenter: N. Tolboom, University Medical Centre Utrecht, Netherlands Date and Time: 22-Oct-24, 16:45 – 18:15 Session: TROP Session: Neuroimaging Committee: Neuro-Oncology Format: Oral Location: Hall Y10-Y12 Presentation ID: OP-758 Title: The emerging role of TLX250-CDx (89Zr-girentuximab) PET/CT in accurate characterisation and staging of ccRCC: early experience with three patients Presenter: F. Gelardi, Università Vita-Salute San Raffaele, Italy Date and Time: 23-Oct-24, 08:00 – 09:30 Session: TROP Session: Case Report Session 2: You Won't Believe the Things I've Seen! Format: Oral Location: Hall Y1-Y3 Presentation ID: OP-824 Title: Development of girentuximab as a theranostic tool in non-renal indications Presenter: A. Ivashkevich, Telix Date and Time: 23-Oct-24, 08:00 – 09:30 Session: e-Poster Presentations Session 13: Translational Molecular Imaging & Therapy Committee: Molecular Imaging & Therapy Format: Oral ePoster Location: Hall F Presentation ID: EPS-270 Title: Preclinical evaluation of DNA damage response inhibitors and TLX252 (225Ac-DOTA-girentuximab) combination therapy Presenter: Z. Cao, Olivia Newton-John Cancer Research Institute, Australia Date and Time: 23-Oct-24, 08:00 – 09:30 Session: e-Poster Presentations Session 13: Translational Molecular Imaging & Therapy Committee: Molecular Imaging & Therapy Format: Oral ePoster Location: Hall F Presentation ID: EPS-269 Title: Development of Kit-Composition for the Preparation of 99mTc-PSMA-GCK01 / RHN001-Dx Presenter: J. Cardinale, University Hospital Duesseldorf, Germany Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D57 Radiopharmaceutical Preparation and Quality Control Format: e-Poster Location: e-Poster Area Presentation ID: EP-1037 Title: Development of 18F-labelled lactate for oxidative cancer imaging Presenter: M. da Silva Morais, Pole of Pharmacology, Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain (UCLouvain), Belgium Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D55 Radiopharmacokinetics and Drug Development Format: e-Poster Location: e-Poster Area Presentation ID: EP-1010 Title: Radiolabelling DOTA-HYNIC-panPSMA with actinium-225 for in vivo studies Presenter: K. Attia, Telix Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D53 New Radiopharmaceuticals - Therapy Format: e-Poster Location: e-Poster Area Presentation ID: EP-0985 About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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). 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 U.S. Food and Drug Administration (FDA)[2], by the Australian Therapeutic Goods Administration (TGA) [3], and by Health Canada [4] . No other Telix product has received a marketing authorisation in any jurisdiction. 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 X and LinkedIn. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] 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) 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. 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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. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix®, SENSEI® and Zircaix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Debiopharm and ITM announced a licensing deal for a ​​radiopharmaceutical treatment that’s being investigated in several cancers. Debiopharm, which is based in Switzerland, is eligible for upfront, development and regulatory milestone payments of about €300 million, or about $331 million, along with commercial milestones and low double-digit royalties on potential future sales. In exchange, the German radiopharma biotech gets exclusive global development and commercialization rights to Debiopharm’s peptide-based theranostic pair, which is a combination of the therapeutic compound Debio 0228 and diagnostic imaging agent Debio 0328. The combo is currently in the Phase 1/2 GaLuCi trial in clear cell renal cell carcinoma, pancreatic ductal adenocarcinoma and colorectal cancer. According to the companies, the treatment combo targets the carbonic anhydrase IX surface protein, which plays a role in promoting tumor survival, growth and metastasis. “Adding a clinical stage theranostic pair that targets the critical CA IX protein aligns seamlessly with our mission to expand access to innovative radiopharmaceuticals on a global scale,” ITM CEO Andrew Cavey said in a statement. Debiopharm CEO Bertrand Ducrey added in a statement that Debio 0328’s “outstanding potential as a stand-alone imaging agent has also boosted our confidence for the upcoming evaluation of Debio 0228, the therapeutic agent.” Back in June , Merck KGaA decided to wind down Phase 3 trials for a cancer drug called xevinapant that it licensed from Debiopharm in 2021 after a failure.

MUNICH & GARCHING, Germany & LAUSANNE, Switzerland I September 12, 2024 I ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company and Debiopharm ( www.debiopharm.com ), a Swiss-based, global biopharmaceutical company, aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, today announced that the companies entered an agreement under which ITM gains the exclusive global license for the clinical and commercial development of the peptide-based, theranostic pair ITM-91/ITM-94D, formerly Debio 0228/0328, targeting the Carbonic Anhydrase IX (CA IX) surface protein. CA IX plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis. ITM-91 ( Debio 0228 ) ([ 177 Lu]Lu-DPI-4452)is a Lutetium-177-labeled radioligand therapeutic compoundand ITM-94D ( Debio 0328 ) ([ 68 Ga]Ga-DPI-4452) is a Gallium-68-labeled imaging agent. The theranostic pair is being investigated in the phase 1/2 GaLuCi™ (NCT05706129) clinical trial in patients living with locally advanced ccRCC, PDAC and CRC. Further terms and financial details have not been disclosed. “Obtaining this clinical-stage theranostic pairing significantly bolsters our radiopharmaceutical pipeline and reinforces our commitment to delivering life-changing diagnostic and therapeutic agents to patients. Adding a clinical stage theranostic pair that targets the critical CA IX protein aligns seamlessly with our mission to expand access to innovative radiopharmaceuticals on a global scale,” said Dr. Andrew Cavey, CEO of ITM . “We see great potential for CA IX-targeted radiopharmaceutical therapies. We look forward to advancing the GaLuCi™ trial and to building the optimal clinical strategy for this molecule.” “Curing patients is our mission. Through this agreement with ITM, we hope to bring breakthrough solutions to patients living with hard-to-treat cancer types. We’re extremely pleased that the trial data generated to-date for our imaging radiotracer have provided high-quality images with high tumor uptake and excellent tumor-to-background ratios. Debio 0328’s outstanding potential as a stand-alone imaging agent has also boosted our confidence for the upcoming evaluation of Debio 0228, the therapeutic agent. As development continues, we are grateful to be able to rely on ITM’s radiopharmaceutical expertise to advance research for patients,” said Bertrand Ducrey, CEO of Debiopharm . Debiopharm is a drug development expert with an evolving radioligand therapy pipeline and strong pre-clinical and clinical competence in this field. Their unique business model allows Debiopharm to continuously bridge the gap between innovative discoveries and leading pharmaceutical companies for commercialization. As the globally leading manufacturer of n.c.a. Lutetium-177 and with a broad pipeline of radiopharmaceutical diagnostic and therapeutic candidates, ITM will use its production capabilities and clinical expertise to advance this theranostic pair. “Patients with advanced renal cancer often have a long and difficult journey, with recurrence after surgery not infrequent and limited treatment options following immune-oncology or tyrosine kinase inhibitor therapy. I have high hopes for trials like GaLuCi™ will finally shift the odds defining both a new PET/CT scan and targeted treatment option,” said Prof. Michael Hofman, Peter MacCallum Cancer of Melbourne and investigator of the Phase 1/2 GaLuCi™ study . “Theranostic approaches are a very exciting treatment modality for patients with hard-to-treat malignancies due to their potential to target specific surface proteins, often regardless of tumor origin. This technique has been shown to improve outcomes for patients with advanced-staged prostate cancer and we are hoping to bring it to the forefront of treatment for kidney cancer,” added Darren R. Feldman, MD, Medical Oncologist, Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center and investigator of the Phase 1/2 GaLuCi™ study . About ITM-91/ ITM-94D (Debio 0228/0328) ITM-91/ ITM-94D ( Debio 0228/0328 ) is an investigational theranostic pair originally discovered by 3B Pharmaceuticals GmbH and now exclusively licensed to ITM. ITM-94D (Debio 0328) ([ 68 Ga]Ga-DPI-4452) is a PET imaging agent that may be used independently and is designed to identify patients whose cancers overexpress CA IX. Once identified, these patients may be treated with the lutetium-labelled radioligand, ITM-91 (Debio 0228) ([ 177 Lu]Lu-DPI-4452), which is designed to deliver targeted radiation to the tumor with the aim to destroy it from the inside. About the GaLuCi™ trial The GaLuCi™ trial is the first-in-human, multicenter, non-randomized phase 1/2 clinical trial assessing safety and tolerability, imaging characteristics, and the efficacy of the theranostic pair ITM-91/ ITM-94D (Debio 0228/0328) in patients with unresectable, locally advanced, or metastatic solid tumors. This theranostic trial is being carried out in three stages. The ongoing Part A is evaluating the safety and performance of the imaging agent in detecting CA IX-expressing solid tumors. Part B will assess escalating doses of the therapeutic agent, ITM-91 (Debio 0228) in patients, whose tumors show high uptake of imaging tracer. Finally, based on the recommended dose from Part B, Part C of the study will further assess the safety and preliminary efficacy of ITM-91 (Debio 0228) in ccRCC, PDAC and CRC. About ITM Isotope Technologies Munich SE ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com Debiopharm’s commitment to patients Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then select large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit www.debiopharm.com We are on X. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews or on LinkedIn SOURCE: Debiopharm