MELBOURNE, Australia, Nov. 22, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that a first patient has been dosed in a Phase II investigator-initiated study of TLX101 in combination with external beam radiation therapy (EBRT) in patients with recurrent high-grade gliomas (HGG), including glioblastoma multiforme (GBM).

TLX101 (4-L-[¹³¹I] iodo-phenylalanine, or ¹³¹I-IPA) is one of Telix's lead therapeutic clinical programs and has been granted orphan drug designation in the U.S. and Europe. TLX101 targets L-type amino acid transporter 1 (LAT-1), typically over-expressed in many malignant tumours, including HGG/GBM.

The IPAX-Linz study, which is being led by Professor Josef Pichler at Kepler University Hospital in Linz, Austria, builds on data generated in the IPAX-1 study. The final results of the IPAX-1 study, reported in September 2022, demonstrated a favourable safety profile and encouraging preliminary therapeutic effect.^[1] IPAX-Linz will continue to study the benefit of TLX101 to patients in the second line (refractory) setting at this leading neuro-oncology site in Europe. Targeting recruitment of 10 patients, the goal of this study is to gather additional data on clinical utility.

IPAX-Linz will run concurrently with IPAX-2, which is evaluating TLX101 in combination with post-surgical standard of care comprised of EBRT and temozolomide in newly diagnosed (first line) GBM patients.

Prof. Josef Pichler, Kepler University Hospital, Austria, Principal Investigator in the IPAX-Linz study said, "Based on promising safety and early efficacy data for TLX101 in the IPAX-1 study, I am pleased to continue to explore this therapeutic modality in a larger patient cohort, where there are currently few effective treatment options. Preliminary results are only achieved thanks to close and optimal cooperation with our colleagues at Ordensklinikum Linz, Barmherzige Schwestern and we are grateful for their contribution to this trial."

Dr. Colin Hayward, Chief Medical Officer of Telix Pharmaceuticals added, "We are pleased to have commenced the IPAX-Linz study, which alongside IPAX-2 supports Telix's goal to expedite the development of a potential new therapy in an aggressive cancer with poor prognosis. We would like to thank Prof. Josef Pichler and his clinical team at Kepler University Hospital, as well as the patients who will contribute to this important study."

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. 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 need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and 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] and by the Australian Therapeutic Goods Administration (TGA),^[3] and by Health Canada.^[4]

Telix Investor Relations

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

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

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[1] ASX disclosure 21 September 2022.
[2] ASX disclosure 20 December 2021.
[3] ASX disclosure 2 November 2021.
[4] ASX disclosure 14 October 2022.