Telix Advances Development of Glioblastoma Treatment Program, Business News


Melbourne, Australia, March 23, 2022 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces that it has made significant progress in advancing the Company’s glioblastoma multiforme (GBM) therapeutic candidate TLX101 to the next stage of clinical development.

TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) is one of the Company’s leading clinical therapeutic programs and has received orphan drug designation in the United States and Europe. TLX101 targets the L-type amino acid transporter 1 (LAT-1), which is typically overexpressed in GBM.

The phase I IPAX-1 study, whose recruitment was completed in 2021,[1] established a favorable safety profile for TLX101 and promise preliminary disease stabilization with evidence of anti-tumor responses in a second-line (refractory) disease setting.[2]

Building on this experience, Telix has now obtained approval from the Human Research Ethics Committee (HREC) to begin a phase I dose escalation study (designated “IPAX-2”) to evaluate TLX101 in combination with standard post-surgical treatment consisting of external beam radiotherapy (EBRT) and temozolomide in patients newly diagnosed with GBM. Twelve patients should be recruited to assess whether the observed safety and drug interaction profile remains appropriate in this setting before proceeding to a phase II study.

Teachers Hui Gan and Andrew Scottfrom the Olivia Newton-John Cancer Research Institute in that of Melbourne Austin Health, are the principal investigators for IPAX-2. TLX101-CDx (18F-FET PET[3]) will be used for imaging in the study to identify participants with overexpressed LAT-1 as suitable candidates for 131I-IPA therapy, and to provide baseline and follow-up information on tumor response and progression.

In addition to the company-sponsored IPAX-2 study, Kepler University Hospital Linz (Austria) has received ethical approval to begin an institution-led Phase II study of TLX101 (referred to as “IPAX-Linz” or “IPAX-L”) in combination with EBRT in patients with relapsed glioblastoma . This provides an opportunity to continue to study patient benefits in the recurrent setting (second line), building on the experience of the IPAX-1 study at this leading neuro-oncology site in Europe.

The IPAX-L study will begin recruiting patients as soon as March 2022. IPAX-L is led by Dr. Josef Picher and will complement the experience gained from Telix’s IPAX-1 study in which Dr. Pichler was also a principal investigator. Telix supports IPAX-L by contributing experimental products and funding.

Doctor Colin HaywardChief Medical Officer of Telix Pharmaceuticals, said: “Completing these concurrent studies will build on the promising data generated in the IPAX-1 study, supporting our goal of accelerating the development of a potential new treatment in aggressive cancer. with limited treatment options. IPAX-2 Telix brings TLX101 development to the front line for the first time Following promising insights from the previous IPAX-1 study, we are excited to see the potential impact of targeted radiation in patients after their initial surgery.

“We are also very pleased to support Dr. Pichler and his team at Kepler University Hospital, to continue the important clinical research on TLX101 in the second line setting and to leverage the IPAX-1 experience to explore new therapeutic options for patients with glioblastoma.

Doctor Josef PicherKepler University Hospital, Austriaprincipal investigator of the IPAX-L study, added: “Based on extensive experience with this asset in the IPAX-1 study, I am convinced that TLX101 should be further investigated to the treatment of brain tumours. Early clinical data showed encouraging results. with a good safety profile. IPAX-Linz will gather additional safety data and preliminary results from the activity.”

On Telix Pharmaceuticals Limited

Telix is ​​a biopharmaceutical company specializing in the development and marketing of diagnostic and therapeutic products using targeted molecular radiation (MTR). Telix is ​​headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerlandand United States. Telix is ​​developing a portfolio of clinical-stage products that address significant unmet medical needs 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 flagship product, Illuccix® (gallium-68 preparation kit (68Ga) gozetotide (also called 68Ga PSMA-11) injectable for prostate cancer imaging, has been approved by the United States Food and Drug Administration (FDA),[4] and by the Australian Therapeutic Goods Administration (TGA).[5] Telix is ​​also pursuing marketing authorization applications for this experimental candidate in Europe[6] and Canada.[7]

This announcement has been authorized for publication by Dr. Christian BehrenbruchManaging Director and Group Chief Executive.

Legal Notice

This announcement may include forward-looking statements relating 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. research statements. Forward-looking statements are based on the Company’s good faith assumptions about existing financial, market, regulatory and other considerations that affect the Company’s business and operations in the future, and there can be no assurance that the any of the assumptions will turn out to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements regarding: the initiation, timing, progress and results of Telix’s preclinical and clinical studies, and Telix’s research and development of Telix; Telix’s ability to advance product candidates, enroll in and complete clinical studies, including multinational clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialization of Telix’s product candidates, if or when they have been approved; estimates of Telix’s expenses, future revenues and capital needs; the financial performance of Telix; 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 differ materially from those expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

To the fullest 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 name and logo are trademarks of Telix Pharmaceuticals Limited and its subsidiaries (all rights reserved).

[1] ASX disclosure June 21, 2021.

[2] ASX Disclosure October 20, 2021.

[3] Positron emission tomography.

[4] ASX disclosure December 20, 2021.

[5] ASX disclosure November 2, 2021.

[6] ASX disclosure December 10, 2021.

[7] ASX Disclosure December 16, 2020.

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