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

Rhea-AI Summary

Telix Pharmaceuticals (ASX:TLX, NASDAQ:TLX) reported completion of patient enrolment in the Phase 1 IPAX-2 dose-finding study of TLX101-Tx in newly diagnosed glioblastoma. Twelve patients across four sites received up to two 5GBq doses (10GBq total) with no dose-limiting toxicities observed.

IPAX-2 will confirm the maximum tolerated dose alongside standard-of-care therapy, while pivotal Phase 3 trial IPAX BrIGHT in recurrent glioblastoma is actively enrolling, described as the first radiopharmaceutical therapy to reach Phase 3 for this cancer.

Positive

• IPAX-2 completed enrolment of 12 glioblastoma patients across four international sites
• No dose-limiting toxicities observed up to total 10GBq TLX101-Tx dose
• Phase 1 IPAX-2 expected to define maximum tolerated dose for further development
• Pivotal Phase 3 IPAX BrIGHT trial in recurrent glioblastoma is actively enrolling
• First radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, according to Telix
• PET imaging agent TLX101-Px used to select LAT1-overexpressing patients and monitor response

Negative

• IPAX-2 Phase 1 study includes only 12 patients in three dose cohorts
• Maximum tolerated dose primary endpoint will be confirmed only after study completion
• No efficacy outcomes from IPAX-2 have been reported in this update
• IPAX BrIGHT Phase 3 trial is still enrolling, with safety and efficacy results pending

News Market Reaction – TLX

-1.07%

-1.07% Session close to close

In the May 19 session, TLX declined 1.07%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights completion of IPAX-2 enrollment and confirms a maximum administered dos...

Analysis

This announcement highlights completion of IPAX-2 enrollment and confirms a maximum administered dose of TLX101-Tx with no observed dose-limiting toxicities in 12 newly diagnosed glioblastoma patients. The study supports ongoing development alongside the pivotal IPAX BrIGHT Phase 3 trial in recurrent disease, reinforcing Telix’s broader neuro-oncology strategy. Recent history shows multiple concurrent programs and regulatory steps, so investors may watch for future efficacy readouts, regulatory decisions, and how imaging agent TLX101-Px integrates with patient selection across the IPAX series.

Key Figures

Maximum dose per administration: 5 GBq Total administered activity: 10 GBq Patients enrolled: 12 patients +5 more

8 metrics

Maximum dose per administration 5 GBq Highest single dose in IPAX-2 without observed DLTs

Total administered activity 10 GBq Two 5 GBq doses in IPAX-2 study

Patients enrolled 12 patients IPAX-2 Phase 1 dose finding study

Dose cohorts 3 cohorts Dose escalation design in IPAX-2

Trial sites 4 sites Australia, Austria, Netherlands in IPAX-2

Phase designation Phase 1 IPAX-2 dose finding trial in newly diagnosed glioblastoma

Phase designation Phase 3 IPAX BrIGHT pivotal trial in recurrent glioblastoma

Assessment days 210-day Active assessment period for TLX101-Px MAA in Europe (prior news)

Historical Context

5 past events · Latest: May 04 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 04	Imaging data update	Positive	-1.0%	Phase 3 ZIRCON analysis showed high PPV, sensitivity, and specificity for TLX250-Px.
Apr 30	Regulatory MAA accepted	Positive	+2.4%	European MAA for TLX101-Px validated and accepted for glioma PET imaging.
Apr 29	Phase 2 trial data	Positive	+5.5%	OPTIMAL-PSMA Phase 2 data highlighted favorable dosimetry and therapeutic potential.
Apr 27	Investor education event	Positive	+0.4%	Announcement of an educational webinar on PSMA-targeted radionuclide therapy portfolio.
Apr 21	Phase 3 ASCO selection	Positive	+1.2%	ProstACT Global Phase 3 Part 1 safety data selected as late-breaking ASCO abstract.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent Telix news has generally been positive, with mostly aligned price gains on clinical and regulatory milestones, but one instance of a negative reaction to favorable imaging data shows occasional divergence.

Recent Company History

Over the past month, Telix has reported several clinical and regulatory milestones. On Apr 21, Phase 3 ProstACT Global Part 1 safety data selection for ASCO 2026 coincided with a +1.17% move. Late April brought OPTIMAL-PSMA Phase 2 data and a TLX101-Px MAA acceptance, with +5.47% and +2.36% reactions. A May 4 ZIRCON analysis showing strong TLX250-Px diagnostic performance saw a modest -0.99% decline, indicating that even strong data can meet mixed market responses.

Key Terms

dose-limiting toxicities, phase 1, phase 3, external beam radiation therapy, +4 more

8 terms

dose-limiting toxicities medical

"Maximum dose reached with no dose-limiting toxicities observed."

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

phase 1 medical

"open-label Phase 1 dose finding study to evaluate the safety and tolerability"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

phase 3 medical

"This marks the first radiopharmaceutical therapy to enter Phase 3 development"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

external beam radiation therapy medical

"in combination with post-surgical standard-of-care treatment (external beam radiation therapy and temozolomide)"

External beam radiation therapy is a medical treatment that directs high-energy beams from a machine outside the body toward a specific area, usually to shrink or destroy tumors; think of it as aiming a focused spotlight at a single spot inside the body without cutting. It matters to investors because its use, effectiveness, and technological advances influence sales of medical equipment, hospital treatment volumes, drug and device partnerships, regulatory decisions and reimbursement policies that affect companies’ revenue and growth prospects.

temozolomide medical

"standard-of-care treatment (external beam radiation therapy and temozolomide) in primary glioblastoma."

An oral chemotherapy drug that works by damaging the DNA of cancer cells so they can no longer grow and divide, most commonly used to treat certain brain tumors. For investors, temozolomide matters because clinical trial results, approvals, patent status, manufacturing supply and safety data can reshape a company’s drug revenue prospects and valuation—think of it as a key product in a biotech’s toolbox whose success or failure directly affects the business outlook.

radiopharmaceutical medical

"continued development of this targeted radiopharmaceutical candidate."

A radiopharmaceutical is a special type of medicine that contains a small amount of radioactive material, used primarily for medical imaging or treatment. It can be thought of as a tiny, targeted signal that helps doctors see inside the body or deliver therapy directly to affected areas. For investors, understanding radiopharmaceuticals is important because they represent a growing field within healthcare, driven by advancements in diagnostics and personalized treatments.

pet imaging medical

"Telix's PET imaging candidate TLX101-Px (floretyrosine F 18) has been used"

PET imaging is a noninvasive medical scan that works like a molecular camera, using tiny radioactive tracers to reveal biological activity inside the body—for example metabolism, blood flow, or the presence of specific proteins. It matters to investors because PET results guide diagnosis, show whether a drug reaches its intended target and how patients respond, and therefore affect clinical trial success, regulatory approval, reimbursement decisions and demand for scanners, tracers and related services.

open-label medical

"multicenter, open-label Phase 1 dose finding study to evaluate the safety"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Add on Google Not now

• 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 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the IPAX-2 study¹ 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 BrIGHT² 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 study³ 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 diagnosis⁴. 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 diagnosis⁵. 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 patients⁷, with an expected survival duration of 12-15 months from diagnosis⁸.

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.

Telix Investor Relations (Global) Ms. Kyahn Williamson SVP Investor Relations and Corporate Communications kyahn.williamson@telixpharma.com	Telix Investor Relations (Australia) Ms. Charlene Jaw Associate Director InvestorRelations charlene.jaw@telixpharma.com	Telix Investor Relations (U.S.)   Ms. Annie Kasparian   Director Investor Relations and Corporate Communications   annie.kasparian@telixpharma.com
Media Contact Eliza Schleifstein 917.763.8106 (Mobile) Eliza@schleifsteinpr.com

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.

¹ ClinicalTrials.gov ID: NCT05450744.
² ClinicalTrials.gov ID: NCT07100730.
³ ClinicalTrials.gov ID: NCT03849105.
⁴ Pichler et al. Neurooncol Adv. 2024. https://doi.org/10.1093/noajnl/vdae130
⁵ Telix ASX disclosure April 16, 2025. Data presented by Professor Josef Pichler at the Nuclear Medicine and Neurooncology (NMN) Symposium in Vienna (Austria), May 2025.
⁶ Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.
⁷ Park et al. Journal of Clinical Oncology. 2010.
⁸ Ostrom et al. Neuro Oncol. 2018.

FAQ

What did Telix (TLX) announce about the IPAX-2 TLX101-Tx study on May 19, 2026?

Telix announced that the Phase 1 IPAX-2 study of TLX101-Tx in newly diagnosed glioblastoma has completed patient enrolment. According to Telix, twelve patients were enrolled across four sites to establish safety, tolerability and the maximum tolerated dose with standard-of-care therapy.

What dosing and safety results were observed for TLX101-Tx in the IPAX-2 glioblastoma trial (TLX)?

IPAX-2 reported no dose-limiting toxicities, even at the maximum administered dose of two 5GBq doses (10GBq total). According to Telix, this Phase 1 trial is assessing safety and tolerability of TLX101-Tx combined with radiation therapy and temozolomide in primary glioblastoma.

How many patients and sites are included in the IPAX-2 Phase 1 TLX101-Tx study (TLX)?

The IPAX-2 study enrolled twelve patients across four sites in Australia, Austria and the Netherlands. According to Telix, patients were treated in three dose-escalation cohorts to evaluate safety, tolerability and to determine the maximum tolerated dose for future development.

What is the role of the IPAX BrIGHT Phase 3 trial for TLX101-Tx in recurrent glioblastoma (TLX)?

IPAX BrIGHT is a pivotal Phase 3 trial evaluating TLX101-Tx plus lomustine versus lomustine alone in recurrent glioblastoma. According to Telix, the study is actively enrolling and dosing patients and is described as the first radiopharmaceutical therapy to reach Phase 3 in this disease.

How does Telix use TLX101-Px imaging in the IPAX series of glioblastoma trials (TLX)?

Telix uses PET imaging candidate TLX101-Px to identify patients with overexpressed LAT1 as suitable for TLX101-Tx therapy. According to Telix, TLX101-Px also provides baseline and follow-up data on tumor response and progression across the IPAX clinical trial program.

What are the next steps after completion of enrolment in the IPAX-2 TLX101-Tx trial (TLX)?

After enrolment, patients remain on standard-of-care treatment until IPAX-2 study completion, when the maximum tolerated dose primary endpoint will be confirmed. According to Telix, these data are intended to guide further development of TLX101-Tx in first-line glioblastoma.