First Patient Dosed in European Named Patient (Early Access) Program for TLX250-CDx, Telix's Kidney Cancer Imaging Agent

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04 Dec, 2023, 05:00 GMT

MELBOURNE, Australia and LIÉGE, Belgium, Dec. 4, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in a named patient (early access) program in the Netherlands for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (⁸⁹Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

Through this named patient program in the Netherlands ('Leveren op Artsenverklaring'), physicians may seek individual access to TLX250-CDx for use in PET characterisation of renal masses as ccRCC. The first patient was dosed at Radboud University Medical Centre in Nijmegen, Netherlands.

The program follows the completion of Telix's successful global Phase III ZIRCON study (Zirconium in Renal Cancer Oncology, ClinicalTrials.gov Identifier: NCT03849118), which reported positive results in November 2022, meeting all co-primary and secondary endpoints.¹

Professor Dr. Peter Mulders from Radboud University Medical Centre (Netherlands), a Principal Investigator on Telix's completed ZIRCON trial commented, "Continued access to this investigational imaging agent is critically important. The detection of ccRCC in the early stages of disease can often be challenging, and reliant on invasive biopsy and nephrectomy (kidney removal). It is therefore extremely good news that TLX250-CDx, which offers a non-invasive option – or 'molecular biopsy' – is now available in the Netherlands on a named patient basis."

Frédéric Fantino, Telix Medical Director for the Europe, Middle East and Africa (EMEA) region, added, "The first patient dosed in this European named patient program is a significant step for Telix to support continued unmet patient need and educate key opinion leaders on the potential of TLX250-CDx to change standard of care in the diagnosis and management of ccRCC. The ZIRCON study has shown this imaging agent to be highly sensitive and specific in the detection of ccRCC, where existing imaging techniques are sometimes inconclusive."

In the Netherlands, the use of a medicinal product in an individual patient prior to marketing authorisation and outside the context of a clinical trial is permitted in exceptional circumstances. Individual requests must be initiated by the treating physician and are evaluated by the Dutch Health Inspectorate (IGJ).

Telix is progressing towards a Biologics License Application (BLA) submission for TLX250-CDx with the United States Food and Drug Administration (FDA) and other equivalent applications with regulatory agencies in key commercial jurisdictions.

Physicians in Europe who may have eligible patients can email eap-emea@telixpharma.com for further information about TLX250-CDx named patient access.

For more information about ongoing clinical trials of TLX250-CDx, please visit https://telixpharma.com/our-portfolio/clinical-trials/

Telix's Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link.

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.

TLX250-CDx has not received a marketing authorisation in any jurisdiction. Telix's lead imaging product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the FDA,² by the Australian Therapeutic Goods Administration (TGA),³ and by Health Canada.⁴

Telix's SENSEI^® ultra-miniaturised robotic gamma probe is registered as a Class 1 device with the FDA, and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area for intra-operative detection of sentinel lymph nodes.⁵

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com

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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 Telix ASX disclosure 7 November 2022.
²Telix ASX disclosure 20 December 2021.
³Telix ASX disclosure 2 November 2021.
⁴Telix ASX disclosure 14 October 2022.
⁵Lightpoint Medical media release 20 January 2021.