Telix to Showcase New ZIRCON Phase III Kidney Cancer Imaging Data and Theranostic Pipeline at EANM

MELBOURNE, Australia, Sept. 6, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces presentations featuring the Company's theranostic programs at the 36^th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Vienna from 9 – 13 September 2023.

Further data from Telix's completed pivotal Phase III ZIRCON study of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) will be presented in on oral session on Sunday 10 September.

In addition, the congress program features the following Telix initiatives:

• Sponsored symposium on personalised diagnostics in urological cancers: the promise of nuclear medicine;
• Phase III ProstACT GLOBAL study of TLX591 investigational prostate cancer therapy;
• Artificial intelligence (AI) Segmentation and primary characterisation of prostate cancer lesions using models trained on ⁶⁸Ga–PSMA–11 image datasets;
• Nobody Left Behind (NOBLE) Registry of Telix's single photon emission computed tomography (SPECT)-based prostate cancer imaging agent TLX599-CDx;^[1] and,
• A preclinical evaluation of carbonic anhydrase IX- (CAIX)-targeted lutetium-177 radionuclide therapy in combination with immune checkpoint inhibition.

Dr Colin Hayward, Telix Chief Medical Officer, said, "We are pleased to be so well represented at this year's EANM Annual Congress, with a sponsored symposium and abstracts accepted across Telix's late-stage prostate and kidney cancer imaging and therapy programs. In addition, our innovations in AI and quantum computing for prostate cancer segmentation and characterisation will be featured in an oral presentation.

"Once again, we will be supporting the EANM Sanjiv Sam Gambhir Young Investigator Award, an exciting opportunity for a junior physician or scientist to further develop their career in radiopharmaceuticals. We look forward to seeing you at booth number 241 to discuss Telix's industry leading theranostic pipeline and opportunities for collaboration."

EANM presentation details are as follows:

• Sponsored Symposium: Personalised diagnostics in urological cancers: the promise of nuclear medicine
• Chairperson: Professor Stefano Fanti, Director of Nuclear Medicine Division and of PET Unit - Policlinico S.Orsola, Bologna, Italy
• Introduction: How PSMA PET dusted off the Management of Prostate Cancer.
• Prostate Cancer Imaging: is there only one PSMA-PET?
• Dr. Macarena Rodríguez Fraile, Nuclear Medicine Clínica Universidad de Navarra, Pamplona, Spain

• Prof. dr. Karolien Goffin, Nuclear Medicine, University Hospital Leuven – KU Leuven, Leuven, Belgium.

• Dr. László Papp, Center for Medical Physics and Biomedical Engineering (CMPBME), Medical University of Vienna, Vienna, Austria.

Session: Theranostics Track - Oncology & Theranostics Committee / EARL - Featured Session: Old but Novel TechniquesTitle: ⁸⁹Zr-DFO-girentuximab PET/CT imaging for clear cell renal cell carcinoma - ZIRCON study results of diagnostic performance, including in very small lesions (oral presentation)Date and Time: 10-Sep-23, 4:20 - 4:30 PMPresenter: Clement Bailly, Nantes University Hospital, Nantes, FRANCEPresentation ID: OP-194

Session: Cutting Edge Science Track - TROP Session: Segmentation and DenoisingTitle: Using a 3-D UNet artificial intelligence model to segment PSMA-avid lesions in ⁶⁸Ga–PSMA–11 PET/CT images (top-rated oral presentation)Date and Time: 10-Sep-23, 4:55 – 5:05 PMPresenter: Simon Wail, Telix Pharmaceuticals, North Melbourne, AUSTRALIAPresentation ID: OP-222

Session: M2M Track - TROP Session: TME and Therapy: Direct Targeting and Secondary EffectsTitle: Evaluation of Therapeutic and Immunological Action of CAIX-Targeted Lutetium-177 Radionuclide Therapy Combined with Immune Checkpoint Inhibition (top-rated oral presentation)Date and Time: 11-Sep-23, 10:15 – 10:25 AMPresenter: Simone Kleinendorst, Department of Medical Imaging, Radboud University Medical Center, Nijmegen, NETHERLANDSPresentation ID: OP-358

Session: Clinical Oncology Track - TROP Session: Prostate Cancer Biochemical RecurrenceTitle: The imaging characteristics of theranostic ^99mTc/¹⁸⁸Re-PSMA-GCK01 is equivalent to dedicated diagnostic ^99mTc-HYNIC-iPSMA in prostate cancer (top-rated oral presentation)Date and Time: 11-Sep-23, 6:05 – 6:15 PMPresenter: Eduards Mamlins, Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Duesseldorf, GERMANYPresentation ID: OP-512

Session: e-Poster Presentations Session 10 – Oncology & Theranostics Committee: Haematological and Abdominal Malignancies / localised TreatmentsTitle: NOBLE (Nobody Left Behind) Registry: Initial Experience of [^99mTc]-HYNIC-iPSMA Imaging in the Detection of Prostate Cancer (oral e-poster presentation)Date and Time: 12-Sep-23, 10:53 – 10:57 AMPresenter: Fuad Novruzov, Department of Nuclear Medicine Azerbaijan National Centre of Oncology, Baku AZERBAIJANPresentation ID: EPS-206

Session: Cutting Edge Science Track - TROP Session: AI Methods and Applications Title: Primary prostate characterization in PSMA-11 PET on real quantum computers (top-rated oral presentation)Date and Time: 12-Sep-23, 3:00 – 03:10 PMPresenter: Laszlo Papp, Medical University of Vienna, Vienna, AUSTRIAPresentation ID: OP-706

Session: Clinical Oncology Track - TROP Session: Prostate Cancer TreatmentTitle: ProstACT GLOBAL: A Phase 3 Study of ¹⁷⁷Lu-DOTA-rosopatamab (TLX591) With and Without the Best Standard of Care for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment with a Novel Androgen Axis Drug (top-rated oral presentation)Date and Time: 12-Sep-23, 3:30 – 3:40 PMPresenter: Neel Patel, Telix Pharmaceuticals, North Melbourne, AUSTRALIAPresentation ID: OP-718

Session: D: Technical Studies -> D5 Radiopharmacy/ Radiochemistry -> D57 Radiopharmaceutical Preparation and Quality ControlTitle: The Optimization of the Current ININ Method of Lu-177-DOTA-HYNIC-iPSMA (e-poster)Presenter: Yehia Omar, Misr Radiology Center, Cairo, EGYPTPresentation ID: EP-0880 

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic 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-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).

Visit www.telixpharma.com 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.

Telix's lead product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, 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]Telix is also progressing Marketing Authorisation Applications for ⁶⁸Ga-PSMA-11 in the United Kingdom and the European Union.^[5]

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com

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