First Patient Dosed in Phase II ‘IPAX-Linz’ Study of TLX101 for Glioblastoma Therapy

First Patient Dosed in Phase II 'IPAX-Linz' Study of TLX101 for Glioblastoma Therapy

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: [email protected]

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

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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. 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.

To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.  

The Telix Pharmaceuticals and the Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

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

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