IPAX-2 Study of TLX101-Tx in First-line Glioblastoma Completes Enrolment and Confirms Dosing

• IPAX-2 study of TLX101-Tx (¹³¹I-iodofalan) has completed patient enrolment.
• Maximum dose reached with no dose-limiting toxicities observed.
• TLX101-Tx is also the subject of a pivotal trial, IPAX BrIGHT, which is actively dosing patients with recurrent glioblastoma.

MELBOURNE, Australia and INDIANAPOLIS, May 19, 2026 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the IPAX-2 study^[1] of TLX101-Tx (¹³¹I-iodofalan) in patients with newly diagnosed glioblastoma has completed patient enrolment. No dose-limiting toxicities (DLTs) have been observed to date, including with two doses of 5GBq (total administered activity of 10GBq), the maximum administered dose in the study.

IPAX-2 is an international, multicenter, open-label Phase 1 dose finding study to evaluate the safety and tolerability of TLX101-Tx in combination with post-surgical standard-of-care treatment (external beam radiation therapy and temozolomide) in primary glioblastoma. Twelve patients were enrolled into three dose escalating cohorts across four sites in Australia, Austria and the Netherlands to assess the safety and tolerability, and to assess the maximum tolerated dose (MTD) for further development. Patients remain on standard-of-care treatment until study completion, after which the MTD primary endpoint will be confirmed.  

Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, "We are pleased to have completed enrolment in IPAX-2, an important milestone in the development of TLX101-Tx as a potential treatment for first-line glioblastoma. The tolerability amongst patients, and the absence of dose-limiting toxicities observed on this study strongly support the continued development of this targeted radiopharmaceutical candidate. We thank the principal investigators, their clinical teams, and the patients who have participated in this important research."

TLX101-Tx is currently also under evaluation in the pivotal IPAX BrIGHT^[2] trial to assess the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone in patients with recurrent glioblastoma (last line). IPAX BrIGHT is actively enrolling and dosing patients in Australia and the Netherlands and is also approved in Austria and Belgium with enrollment to begin soon. This marks the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma.

Telix’s PET imaging candidate TLX101-Px (floretyrosine F 18) has been used across the IPAX series of trials to identify participants with overexpressed LAT1 as suitable candidates for TLX101-Tx therapy, and to provide baseline and follow-up information on tumor response and progression.

About TLX101-Tx

TLX101-Tx (¹³¹I-iodofalan) is a systemically administered radiopharmaceutical therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in glioblastoma. TLX101-Tx utilizes a small molecule approach due to the need to cross the blood brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain. In addition to IPAX-2, TLX101-Tx was also the subject of the IPAX-1 study^[3] in recurrent glioblastoma, which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis^[4]. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx in the recurrent setting were consistent and confirmatory to IPAX-1, with a median OS of 11.9 months from the relapse prior to trial enrollment and 32.2 months from initial diagnosis^[5]. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx.

TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma. TLX101-Tx and TLX101-Px have not received a marketing authorization in any jurisdiction and are for investigational use only.

About glioblastoma  

Glioblastoma (GBM), is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.^[6]. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients^[7], with an expected survival duration of 12-15 months from diagnosis^[8].

About Telix Pharmaceuticals Limited

Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland) and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Legal Notices
Cautionary Statement Regarding Forward-Looking Statements. 
 

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, 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", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. 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 Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’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, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including TLX101-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business, including as a result of war or other geopolitical conflicts; 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.

Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.

©2026 Telix Pharmaceuticals Limited. All rights reserved.

Source