IPAX-Linz Study Reports Promising Efficacy for TLX101 Glioma Therapy Candidate
Telix Pharmaceuticals (ASX/NASDAQ: TLX) has announced promising preliminary results from its Phase 2 IPAX-Linz study of TLX101 therapy for recurrent high-grade glioma. The study, combining TLX101 with external beam radiation therapy (EBRT), demonstrated a median overall survival of 12.4 months from treatment initiation, or 32.2 months from initial diagnosis.
The trial included eight patients, with treatment well-tolerated and no serious adverse events reported. Five patients had MGMT unmethylated tumors, typically associated with poor prognosis. The results corroborated the positive efficacy signal from the earlier IPAX-1 study, which showed 13 months median survival from treatment.
Telix is advancing its TLX101 development program with ongoing IPAX-2 study in front-line glioblastoma. The company has submitted for ethics approval a registration-enabling study, planning to begin patient enrollment at Australian sites in H2 2025, with U.S. sites expansion following an IND application in H1 2025.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) ha annunciato promettenti risultati preliminari dal suo studio di Fase 2 IPAX-Linz sulla terapia TLX101 per il glioma di alto grado recidivante. Lo studio, che combina TLX101 con la radioterapia esterna (EBRT), ha mostrato una sopravvivenza mediana complessiva di 12,4 mesi dall'inizio del trattamento, o 32,2 mesi dalla diagnosi iniziale.
La sperimentazione ha coinvolto otto pazienti, con un trattamento ben tollerato e senza eventi avversi gravi segnalati. Cinque pazienti avevano tumori MGMT non metilati, generalmente associati a una prognosi sfavorevole. I risultati confermano il segnale di efficacia positivo emerso dallo studio precedente IPAX-1, che aveva mostrato una sopravvivenza mediana di 13 mesi dal trattamento.
Telix sta proseguendo il programma di sviluppo di TLX101 con lo studio IPAX-2 in corso sul glioblastoma di prima linea. L'azienda ha presentato per l'approvazione etica uno studio abilitante alla registrazione, pianificando di iniziare il reclutamento dei pazienti nei siti australiani nella seconda metà del 2025, con un'espansione negli Stati Uniti dopo la presentazione di una domanda IND nella prima metà del 2025.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) ha anunciado resultados preliminares prometedores de su estudio de Fase 2 IPAX-Linz sobre la terapia TLX101 para glioma de alto grado recurrente. El estudio, que combina TLX101 con radioterapia externa (EBRT), mostró una supervivencia global mediana de 12,4 meses desde el inicio del tratamiento, o 32,2 meses desde el diagnóstico inicial.
El ensayo incluyó a ocho pacientes, con un tratamiento bien tolerado y sin eventos adversos graves reportados. Cinco pacientes tenían tumores MGMT no metilados, típicamente asociados con mal pronóstico. Los resultados corroboran la señal positiva de eficacia del estudio previo IPAX-1, que mostró una supervivencia mediana de 13 meses desde el tratamiento.
Telix está avanzando en su programa de desarrollo de TLX101 con el estudio IPAX-2 en curso en glioblastoma de primera línea. La compañía ha presentado para aprobación ética un estudio habilitante para registro, planeando comenzar la inclusión de pacientes en sitios australianos en la segunda mitad de 2025, con expansión a sitios en EE. UU. tras una solicitud IND en la primera mitad de 2025.
Telix Pharmaceuticals (ASX/NASDAQ: TLX)는 재발성 고등급 교모세포종 치료제 TLX101의 2상 IPAX-Linz 연구에서 유망한 예비 결과를 발표했습니다. TLX101과 외부 방사선 치료(EBRT)를 병용한 이번 연구는 치료 시작 시점부터 중앙 전체 생존 기간이 12.4개월, 초기 진단 시점부터는 32.2개월임을 보여주었습니다.
임상시험에는 8명의 환자가 참여했으며, 치료는 잘 견뎌졌고 심각한 부작용은 보고되지 않았습니다. 다섯 명의 환자는 일반적으로 예후가 좋지 않은 MGMT 비메틸화 종양을 가지고 있었습니다. 이번 결과는 이전 IPAX-1 연구에서 치료 시작 후 중앙 생존 기간이 13개월임을 보여준 긍정적인 효능 신호를 뒷받침합니다.
Telix는 1차 교모세포종 대상 IPAX-2 연구를 진행하며 TLX101 개발 프로그램을 계속 추진하고 있습니다. 회사는 등록 승인용 연구에 대한 윤리 심사를 제출했으며, 2025년 하반기에 호주 사이트에서 환자 등록을 시작할 계획이며, 2025년 상반기에 IND 신청 후 미국 사이트로 확장할 예정입니다.
Telix Pharmaceuticals (ASX/NASDAQ : TLX) a annoncé des résultats préliminaires prometteurs issus de son étude de phase 2 IPAX-Linz sur la thérapie TLX101 pour le gliome de haut grade récurrent. L'étude, combinant TLX101 avec la radiothérapie externe (EBRT), a démontré une survie globale médiane de 12,4 mois à partir du début du traitement, ou 32,2 mois depuis le diagnostic initial.
Le essai a inclus huit patients, le traitement ayant été bien toléré sans événements indésirables graves signalés. Cinq patients présentaient des tumeurs MGMT non méthylées, généralement associées à un mauvais pronostic. Les résultats confirment le signal d'efficacité positif de l'étude IPAX-1 précédente, qui avait montré une survie médiane de 13 mois à partir du traitement.
Telix poursuit son programme de développement de TLX101 avec l'étude IPAX-2 en cours sur le glioblastome de première ligne. La société a soumis pour approbation éthique une étude permettant l'enregistrement, prévoyant de commencer le recrutement des patients sur des sites australiens au second semestre 2025, avec une extension aux sites américains après une demande IND au premier semestre 2025.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) hat vielversprechende vorläufige Ergebnisse aus seiner Phase-2-Studie IPAX-Linz zur TLX101-Therapie bei rezidivierendem hochgradigem Gliom bekanntgegeben. Die Studie, die TLX101 mit externer Strahlentherapie (EBRT) kombiniert, zeigte ein medianes Gesamtüberleben von 12,4 Monaten ab Behandlungsbeginn bzw. 32,2 Monate ab Erstdiagnose.
Die Studie umfasste acht Patienten, die Behandlung wurde gut vertragen, und es wurden keine schwerwiegenden unerwünschten Ereignisse gemeldet. Fünf Patienten hatten MGMT-unmethylierten Tumore, die typischerweise mit einer schlechten Prognose verbunden sind. Die Ergebnisse bestätigen das positive Wirksamkeitssignal aus der früheren IPAX-1-Studie, die ein medianes Überleben von 13 Monaten ab Behandlung zeigte.
Telix treibt sein TLX101-Entwicklungsprogramm mit der laufenden IPAX-2-Studie beim Erstlinien-Glioblastom voran. Das Unternehmen hat eine ethische Genehmigung für eine registrierungsrelevante Studie eingereicht und plant, im zweiten Halbjahr 2025 mit der Patientenrekrutierung an australischen Standorten zu beginnen, mit einer Erweiterung auf US-Standorte nach Einreichung eines IND-Antrags im ersten Halbjahr 2025.
- Median overall survival of 12.4 months vs 9.9 months with EBRT alone
- No serious adverse events reported even at higher doses
- Positive efficacy demonstrated in patients with poor prognosis (MGMT unmethylated tumors)
- Registration-enabling study advancement with planned expansion to U.S. market
- Small patient sample size (only 8 patients)
- Single-arm study design limits comparative effectiveness analysis
Insights
The Phase 2 IPAX-Linz study results for TLX101 represent a meaningful advancement in the recurrent high-grade glioma treatment landscape. The reported median overall survival of 12.4 months from treatment initiation (32.2 months from diagnosis) compares favorably to the typical 9.9 months seen with external beam radiation therapy alone in this setting.
What's particularly noteworthy is that five of eight patients had MGMT unmethylated tumors, which typically carry a worse prognosis. Despite this challenging patient profile, TLX101 demonstrated encouraging efficacy. The safety profile is equally important - the treatment was well-tolerated with no serious adverse events at higher doses than previous studies.
The data corroborates findings from the earlier IPAX-1 study, adding consistency to TLX101's clinical profile. While this study's small sample size (n=8) limits statistical power, the consistent signal across two studies strengthens the underlying efficacy case.
The progression to a registration-enabling study indicates regulatory confidence. With ethics approval submission complete and plans for patient enrollment in Australia in H2 2025, followed by US expansion pending IND approval, Telix is establishing a clear path to potential regulatory consideration.
For glioblastoma patients, where treatment options remain severely and outcomes poor, these results offer a potential new therapeutic approach in the recurrent setting where effective options are most desperately needed.
This clinical update represents a significant step forward in Telix's glioblastoma program. The company is advancing on multiple fronts: showing preliminary efficacy in the IPAX-Linz study, moving forward with front-line investigations via IPAX-2, and preparing a registration-enabling study.
The combination of TLX101 therapy with external beam radiation therapy achieved a 2.5-month survival advantage compared to radiation alone in this difficult-to-treat population. This improvement, while modest in absolute terms, is clinically meaningful in glioblastoma, where even small gains represent progress.
Telix's approach includes both a therapeutic (TLX101) and companion diagnostic (TLX101-CDx/Pixclara), which is notable as it allows for better patient selection through amino acid uptake imaging. This theranostic approach could provide a competitive advantage and improved targeting precision.
The regulatory strategy appears well-structured, with simultaneous pursuit of approvals in multiple regions. The pre-IND meeting with the FDA in Q4 2024 and planned IND submission in H1 2025 establish a clear regulatory timeline.
For Telix's portfolio, this program complements their other radiopharmaceutical assets in prostate cancer and renal cancer. Success in glioblastoma would strengthen the company's position in the growing targeted radiopharmaceutical sector and address a significant unmet medical need where few effective options exist. While commercialization remains at least 2+ years away, these positive signals maintain momentum for this important program.
MELBOURNE, Australia and INDIANAPOLIS, April 16, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan1) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study2.
IPAX-Linz is a single-arm Phase 2 investigator-initiated trial (IIT). IPAX-Linz evaluates the safety, tolerability and preliminary efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT). The target patient population is patients at first or second recurrence with high-grade gliomas (HGG), including glioblastoma.
Treatment with TLX101 was well tolerated with no serious adverse events reported. IPAX-Linz demonstrated encouraging preliminary efficacy data, indicating a median overall survival (OS) of 12.4 months from the initiation of treatment with TLX101, or 32.2 months from initial diagnosis3. This is consistent with the positive efficacy signal generated in the IPAX-1 study in patients at first recurrence, with only one prior resection and treatment with standard chemoradiotherapy. IPAX-1 reported a median OS of 13 months from the initiation of treatment with TLX101, or 23 months from initial diagnosis4. In comparison, recurrent glioblastoma patients treated with EBRT alone have a reported median survival of 9.9 months from treatment5.
Eight patients were included in the study with adaptive dosing of intravenous TLX101 up to administered activity of 4 GBq before, and up to 2 GBq after, second line EBRT, administered in sequential injections. Inclusion criteria comprised patients with glioblastoma with current evidence of first or second recurrence after standard radiochemotherapy, at least six months since end of first line EBRT, and molecular imaging with Telix’s investigational PET6 agent for glioma, TLX101-CDx (Pixclara®7, 18F-floretyrosine, or 18F-FET), indicating pathologically increased amino acid uptake. Surgery for relapsed tumors was allowed. Of the eight IPAX-Linz patients, five had MGMT unmethylated tumors8, typically associated with especially poor prognosis.
Professor Josef Pichler, Kepler University Hospital, Austria, Principal Investigator in the IPAX-Linz, IPAX-1, and IPAX-2 studies, commented, “These preliminary results in relapsed patients showed that TLX101 treatment was very well tolerated, with no serious adverse events, at a higher dose than in previous studies. Early efficacy from IPAX-1 was corroborated, despite the poor prognostic parameters with MGMT unmethylated tumors and multiple relapses before commencing experimental therapy in this IPAX-Linz study. TLX101 continues to show significant potential to improve outcomes for patients living with high-grade glioma. These results also potentially support higher therapeutic doses in subsequent prospective controlled studies.”
Dr. David Cade, Chief Medical Officer at Telix, said, “These are encouraging results, offering new options for patients with historically poor outcomes. We are grateful to Dr. Pichler and his team for building on the IPAX-1 study in a more advanced and complex study cohort that is also representative of a real-world patient population.”
Preliminary results from IPAX-Linz will be presented by Dr. Pichler at the Nuclear Medicine and Neurooncology (NMN) Symposium taking place in Vienna, Austria from 9 – 10 May 2025. Visit the event website for further information: https://www.nmn-society.org/
TLX101 Development Program and Registration-Enabling Study Update
Telix continues to investigate TLX101 in front-line and recurrent settings. IPAX-2, a Phase 1/2 study in front-line glioblastoma in combination with standard of care and using TLX101-CDx as a companion diagnostic, continues to recruit patients.
Telix has submitted for ethics approval a registration-enabling study of TLX101 in recurrent glioblastoma. Subject to approval this will enable patient enrolment to commence at Australian sites in H2 2025, ahead of international expansion. Following the successful pre-IND9 meeting with the U.S. Food and Drug Administration (FDA) in Q4 2024, the Company is also on track to submit an IND application in H1 2025, with the goal of commencing the study at U.S. sites in H2 2025.
About TLX101
TLX101 (131I-iodofalan or 131I-IPA) is a systemically administered targeted radiation therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in glioblastoma. TLX101 therapy 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. TLX101 has received orphan drug designation in the U.S. and Europe for the treatment of glioma. TLX101 and TLX101-CDx have not received a marketing authorization in any jurisdiction.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. 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 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
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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1 131I-iodofalan is the International Nonproprietary Name (INN) assigned to TLX101 by the World Health Organization. TLX101 is also known as 4-L-[131I] iodo-phenylalanine, or 131I-IPA.
2 Telix ASX disclosure 21 September 2022. Pichler et al. Neurooncol Adv. 2024. ClinicalTrials.gov ID: NCT03849105.
3 Primary endpoints were safety and tolerability; secondary endpoints comprised progression-free survival and overall survival.
4 Collation of available data, not from head-to-head data. Cross-trial results should be interpreted with caution and may require further follow-up or validation.
5 Kulinich et al. Acta Neurochir (Wien). 2021.
6 Positron emission tomography.
7 Brand name subject to final regulatory approval.
8 MGMT (O6-methylguanine-DNA methyltransferase) is an enzyme that repairs DNA damage caused by chemotherapy, leading to resistance.
9 Investigational New Drug.
FAQ
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