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

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Sep 06, 2023, 02:44 ET

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.

Professor Stefano Fanti.

Prostate Cancer Imaging: is there only one PSMA-PET?

Dr. Macarena Rodríguez Fraile, Nuclear Medicine Clínica Universidad de Navarra, Pamplona, Spain

Next Generation Imaging in Urology: What's new in Bladder and Kidney Cancers.

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

The Use of Artificial Intelligence in Prostate Cancer Management.

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

Date & Time: Sunday, 10 September, 2023, 1:15 – 2:45 PM (CEST).

Session: Theranostics Track - Oncology & Theranostics Committee / EARL - Featured Session: Old but Novel Techniques
Title: 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 PM
Presenter: Clement Bailly, Nantes University Hospital, Nantes, FRANCE
Presentation ID: OP-194

Session: Cutting Edge Science Track - TROP Session: Segmentation and Denoising
Title: 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 PM
Presenter: Simon Wail, Telix Pharmaceuticals, North Melbourne, AUSTRALIA
Presentation ID: OP-222

Session: M2M Track - TROP Session: TME and Therapy: Direct Targeting and Secondary Effects
Title: 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 AM
Presenter: Simone Kleinendorst, Department of Medical Imaging, Radboud University Medical Center, Nijmegen, NETHERLANDS
Presentation ID: OP-358

Session: Clinical Oncology Track - TROP Session: Prostate Cancer Biochemical Recurrence
Title: 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 PM
Presenter: Eduards Mamlins, Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Duesseldorf, GERMANY
Presentation ID: OP-512

Session: e-Poster Presentations Session 10 – Oncology & Theranostics Committee: Haematological and Abdominal Malignancies / localised Treatments
Title: 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 AM
Presenter: Fuad Novruzov, Department of Nuclear Medicine Azerbaijan National Centre of Oncology, Baku AZERBAIJAN
Presentation 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 PM
Presenter: Laszlo Papp, Medical University of Vienna, Vienna, AUSTRIA
Presentation ID: OP-706

Session: Clinical Oncology Track - TROP Session: Prostate Cancer Treatment
Title: 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 PM
Presenter: Neel Patel, Telix Pharmaceuticals, North Melbourne, AUSTRALIA
Presentation ID: OP-718

Session: D: Technical Studies -> D5 Radiopharmacy/ Radiochemistry -> D57 Radiopharmaceutical Preparation and Quality Control
Title: The Optimization of the Current ININ Method of Lu-177-DOTA-HYNIC-iPSMA (e-poster)
Presenter: Yehia Omar, Misr Radiology Center, Cairo, EGYPT
Presentation 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 Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]

Legal Notices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements 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", "outlook", "forecast" and "guidance", or other similar words. 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 the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company'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 studies, 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, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; 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.

Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.

^[1] A collaboration with the Oncidium Foundation.

^[2] Telix ASX disclosure 20 December 2021.

^[3]Telix ASX disclosure 2 November 2021.

^[4] Telix ASX disclosure 14 October 2022.

^[5]Telix ASX disclosure 3 April 2023.

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