Telix Advances Development of Glioblastoma Therapy Program

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Mar 22, 2022, 21:47 ET

MELBOURNE, Australia, March 22, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces it has made significant progress in advancing the Company's glioblastoma multiforme (GBM) therapy candidate TLX101 into the next stage of clinical development.

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

The IPAX-1 Phase I study, which completed recruitment in 2021,^[1] established a favourable safety profile for TLX101 and promising preliminary disease stabilisation with evidence of anti-tumour responses in a second-line (refractory) disease setting.^[2]

Building on this experience, Telix has now been granted Human Research Ethics Committee (HREC) approval to commence a Phase I dose escalation study (called "IPAX-2") to evaluate TLX101 in combination with post-surgical standard of care comprised of external beam radiation therapy (EBRT) and temozolomide in newly diagnosed GBM patients. Twelve patients are expected to be recruited to evaluate whether the observed safety and drug interaction profile remains suitable in this setting before progressing to a Phase II study.

Professors Hui Gan and Andrew Scott, of the Olivia Newton-John Cancer Research Institute at Melbourne's 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 over-expressed LAT-1 as suitable candidates for ¹³¹I-IPA therapy, and to provide baseline and follow up information on tumour response and progression.

In addition to the Company-sponsored IPAX-2 study, Kepler University Hospital in Linz (Austria) has received ethics approval to commence an institution-led Phase II study of TLX101 (called "IPAX-Linz", or "IPAX-L") in combination with EBRT in patients with relapsed-glioblastoma. This provides an opportunity to continue to study the benefit to patients in the recurrent (second line) setting, building on the experience of the IPAX-1 study at this leading neuro-oncology site in Europe.

The IPAX-L study will commence enrolling patients as early as March 2022. IPAX-L is being led by Dr Josef Pichler and will supplement the experience obtained from Telix's IPAX-1 study in which Dr Pichler was also a Principal Investigator. Telix is supporting IPAX-L through the contribution of investigational product and funding.

Dr Colin Hayward, Chief Medical Officer of Telix Pharmaceuticals stated, "Running these concurrent studies will build on the promising data generated in the IPAX-1 study, supporting our goal to expedite the development of a potential new therapy in an aggressive cancer with limited therapeutic options. With IPAX-2 Telix is taking the development of TLX101 into the front-line setting for the first time. Following the 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 into TLX101 in the second-line setting and build on the IPAX-1 experience to explore new therapeutic options for glioblastoma patients."

Dr Josef Pichler, Kepler University Hospital, Austria, Principal Investigator in 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 for the treatment of brain tumours. The first clinical data has shown encouraging results with a good safety profile. IPAX-Linz will gather additional data on safety and preliminary activity results."

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that 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, Illuccix^® (kit for preparation of gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection for prostate cancer imaging, has been approved by the U.S. Food and Drug Administration (FDA),^[4] and by the Australian Therapeutic Goods Administration (TGA).^[5] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe^{^[6]} and Canada.^{^[7]}

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

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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 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.

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.

^[1] ASX disclosure 21 June 2021.

^[2] ASX disclosure 20 October 2021.

^[3] Positron Emission Tomography.

^[4] ASX disclosure 20 December 2021.

^[5] ASX disclosure 2 November 2021.

^[6] ASX disclosure 10 December 2021.

^[7] ASX disclosure 16 December 2020.

SOURCE Telix Pharmaceuticals Limited