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

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25 Mar, 2024, 09:04 GMT

MELBOURNE, Australia, March 25, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in its named patient program in Italy for TLX250-CDx (⁸⁹Zr-DFO-girentuximab, Zircaix™^[1]). TLX250-CDx is the Company's investigational non-invasive carbonic anhydrase IX (CAIX) targeting positron emission tomography (PET) imaging agent for clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

The first patient was dosed at IRCCS Ospedale San Raffaele in Milan, Italy. Through this program ('accesso allargato'), physicians may seek individual patient access to TLX250-CDx for use in PET characterisation of renal masses as ccRCC.

This 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.^[2]

Arturo Chiti, Professor in Diagnostic Imaging and Radiotherapy at IRCCS Ospedale San Raffaele commented, "Continued access in Europe to TLX250-CDx is vitally important to enable early detection of ccRCC, which can often be challenging and reliant on invasive biopsy and nephrectomy (kidney removal). In TLX250-CDx, I am extremely pleased to be able to offer a non-invasive 'Molecular Biopsy™' to address unmet need in my patients in Italy."

Frédéric Fantino, Telix Medical Director for the Europe, Middle East and Africa (EMEA) region continued, "We are pleased to support unmet patient need by adding a second European country to Telix's global expanded access program for TLX250-CDx. Through the ZIRCON study, this investigational agent has demonstrated high sensitivity and specificity in the detection of ccRCC with potential to change standard of care in the diagnosis and management of this most aggressive form of kidney cancer."

In Italy, 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 and regulated by the Ministry of Health.

Italy becomes the third active country in Telix's global expanded access program, where first patients were dosed in the Netherlands^[3] and the United States (U.S.)^[4] in December 2023. Telix has commenced the regulatory filing for TLX250-CDx (Zircaix™^[1]) with the U.S. Food and Drug Administration (FDA) under a Biologics License Application (BLA) rolling submission^[5] and is progressing 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 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).

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 X and 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,^[6] by the Australian Therapeutic Goods Administration (TGA),^[7] and by Health Canada.^[8]

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

Legal Notices

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. 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. The information contained in this announcement is subject to change without notification.

This announcement may contain 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. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website.

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[1] Trade name subject to final regulatory approval.
[2] Telix ASX disclosure 7 November 2022.
[3] Telix media release 4 December 2023.
[4] Telix media release 11 December 2023.
[5] Telix ASX disclosure 19 December 2023.
[6] Telix ASX disclosure 20 December 2021.
[7] Telix ASX disclosure 2 November 2021.
[8] Telix ASX disclosure 14 October 2022.