First Patient Dosed in U.S. Expanded Access Program for TLX250-CDx, Telix's Breakthrough Kidney Cancer Imaging Agent

MELBOURNE, Australia and INDIANAPOLIS, Dec. 11, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in a United States (U.S.) expanded access program (EAP, ClinicalTrials.gov ID: NCT06090331^[1]) for TLX250-CDx (⁸⁹Zr-DFO-girentuximab). TLX250-CDx is the Company's first-in-class, non-invasive investigational positron emission tomography (PET) imaging agent in clear cell renal cell carcinoma (ccRCC).

The patient was dosed at ARA Diagnostic Imaging at Austin Radiological Association in Austin (TX, U.S.) following U.S. Food and Drug Administration (FDA) agreement to proceed.

FDA agreement for an EAP follows the completion of Telix's successful global Phase III ZIRCON study (Zirconium in Renal Cancer Oncology, ClinicalTrials.gov ID: NCT03849118), which reported positive results in November 2022, meeting all co-primary and secondary endpoints.^[1][2]

Dr John Leahy, molecular radiologist and nuclear medicine specialist at ARA Diagnostic Imaging and a Principal Investigator on the EAP stated, "With TLX250-CDx, for the first time, urologists and urologic oncologists may have a non-invasive way to determine the presence of ccRCC, the most common and aggressive form of kidney cancer. We are therefore extremely pleased to have been selected as the inaugural site for this national EAP, with patients in Austin and the surrounding area now able to benefit from greater confidence in their kidney cancer diagnosis and treatment planning."

Mary Jessel, Senior Vice President of Global Medical Affairs at Telix added: "Ahead of regulatory approval, this EAP provides continued access to TLX250-CDx to address a clear unmet patient need. ZIRCON results demonstrate that TLX250-CDx has potential to become a new standard of care in the diagnosis and staging of ccRCC, where existing imaging can be inconclusive."

Under its EAPs – sometimes called 'compassionate use' – the FDA works with companies to allow access to investigational products outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options.

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

U.S. patients, or physicians who may have eligible patients in the U.S., can e-mail eap-americas@telixpharma.com^[3] for further information about the TLX250-CDx EAP.

Telix's Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link^[4].

For more information about ongoing clinical trials of TLX250-CDx, please visit https://telixpharma.com/our-portfolio/clinical-trials/^[5]

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^[6] 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^[7].

TLX250-CDx has not received a marketing authorisation in any jurisdiction. 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]

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 RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com^[8]

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.

©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

References

1. ^{^} NCT06090331 (clinicaltrials.gov)
2. ^{^} NCT03849118 (clinicaltrials.gov)
3. ^{^} eap-americas@telixpharma.com (www.prnasia.com)
4. ^{^} link (telixpharma.com)
5. ^{^} https://telixpharma.com/our-portfolio/clinical-trials/ (telixpharma.com)
6. ^{^} www.telixpharma.com (www.telixpharma.com)
7. ^{^} LinkedIn (www.linkedin.com)
8. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)