131I-iodofalan (TLX101) / Telix, China Grand Pharma - LARVOL DELTA

TLX101 Development Program and Registration-Enabling Study Update (GlobeNewswire) - "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-IND 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."

IND • Trial status • Glioblastoma

IPAX-Linz Study Reports Promising Efficacy for TLX101 Glioma Therapy Candidate (GlobeNewswire) - P2 | N=10 | IPAX-Linz-01 (2021-006426-43) | "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 diagnosis....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."

P2 data • Glioblastoma

18F-Floretyrosine Expanded Access Program (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

New trial • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

IPAX-2: Phase 1 safety and dose finding study of [131I]IPA plus standard of care in patients with newly diagnosed glioblastoma (SNO 2024) - P1 | "18F-FET PET will be used to identify suitable candidates with LAT1/2 overexpression, establish a baseline, and provide quantitative follow-up information. Primary outcome measures are 1) incidence rate treatment-emergent adverse events and 2) safety and tolerability by determining the dose-limiting toxicity, maximum tolerated dose, and recommended phase 2 dose."

Clinical • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara) Brain Cancer Imaging Agent (GlobeNewswire) - "Telix Pharmaceuticals Limited...announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara), an agent for the imaging of glioma. The application has been granted priority review and designated a PDUFA goal date of 26 April 2025, paving the way for a U.S. commercial launch in 2025...Pixclara to be potentially utilised as a companion diagnostic agent to TLX101 (131I-iodofalan, or 131I-IPA), Telix’s LAT1-targeting investigational glioblastoma (GBM) therapy..."

Diagnostic • FDA filing • PDUFA • Glioblastoma

Telix Featured in 13 Abstracts at the Annual Congress of the European Association of Nuclear Medicine (EANM) (PRNewswire) - "Telix's extensive theranostic pipeline will be showcased in presentations covering...TLX101 (131I-iodofalan or 131I-IPA) glioblastoma therapy; TLX66 (90Y-besilesomab) bone marrow conditioning therapy; TLX252 (225Ac-girentuximab) carbonic anhydrase IX (CAIX)-targeted alpha therapy..."

Clinical data • Glioma

Feasibility and tolerability of [¹³¹I]I-PA monotherapy in progressive and recurrent high grade gliomas; an ongoing single institution case series. (EANM 2024) - "Aim/Introduction: In a phase I-study, safety and tolerability of intravenous 4-L-[131I]iodo-phenylalanine ([¹³¹I]I-PA, TLX101, Telix Pharmaceuticals) administered concurrently with second line external beam radiation therapy in patients with recurrent glioblastoma has been demonstrated, with encouraging preliminary efficacy data... In this ongoing case series of [1³¹I]I-PA monotherapy in recurrent high-grade gliomas, treatment was feasible and well tolerated. Adequate targeting was revealed at post-therapy SPECT imaging."

Clinical • Monotherapy • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor

Impact of FET-PET imaging in surveillance of theranostic treatment with 4-L-[131I]iodo-phenylalanine ([131I]IPA) in relapsed glioblastoma patients (EANO 2024) - "This pilot study demonstrated different outcome in respect of PFS depending on whether MRI or PET RANO criteria have been used for analysis. Further, application of PET RANO criteria showed varying results in terms of response for each individual parameter (TBRmax, TBRmean and PETvolume). Based on our data, the value of an additional PET scan for a valid prediction of response in recurrent GBM patients must be discussed."

Clinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • PAX1

IPAX-1 Study of TLX101 Investigational Glioblastoma Therapy Published in Neuro-Oncology Advances (PRNewswire) - P1/2 | N=10 | IPAX-1 (NCT03849105) | Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited | "Telix Pharmaceuticals Limited...announces that the Company's IPAX-1 Phase I study has been published in Neuro-Oncology Advances, confirming the safety and tolerability profile, and early efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT) in recurrent glioblastoma....All dosing regimens were well tolerated....Stable disease with MRI assessment was observed in 4 of 9 patients at 3 months post-treatment (3-month follow-up, 1 patient did not reach protocol-mandated end of study), yielding a response rate of 44.4%....Median progression-free survival was 4.3 months (95% confidence interval, 3.3–4.5), while median OS was 13 months from the initiation of treatment (95% confidence interval, 7.1–27), or 23 months from initial diagnosis."

P1 data • Glioblastoma

Results from a phase I study of 4-l-[131I]iodo-phenylalanine ([131I]IPA) with external radiation therapy in patients with recurrent glioblastoma (IPAX-1). (PubMed, Neurooncol Adv) - "Median progression-free survival was 4.3 months (95% confidence interval [CI]: 3.3-4.5), while median overall survival was 13 months (95% CI: 7.1-27). Single or fractionated doses of [131I]IPA plus XRT were associated with acceptable tolerability and specific tumor targeting in patients with recurrent GBM, warranting further investigation."

Journal • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

With IPO on ice, radiopharma Telix to raise nearly $400M in bond sale (Firstwordpharma Press Release) - "Telix Pharmaceuticals has turned to the bond market to raise funds to accelerate clinical development of its theranostic portfolio, just over a month after abandoning plans to list its shares in the US. The Australian company noted Tuesday that it expects to pull in AUD 600 million ($398 million) through an offering of convertible notes....The funds will go toward label-expansion studies to broaden the market opportunity across its portfolio of diagnostic imaging agents and to conduct pivotal trials of two therapy programmes. These include TLX250 (177Lu-DOTA-girentuximab) for renal cancer and TLX101 (131I-IPA) for glioblastoma."

Financing • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioblastoma • Glioma • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

First Patient Dosed in IPAX-2 Study of TLX101 Brain Cancer Therapy Candidate in Patients with Newly Diagnosed Glioblastoma (PRNewswire) - "Telix Pharmaceuticals Limited...announces that a first patient has been dosed in a Phase I study of the Company's investigational therapy TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in combination with post-surgical standard of care treatment in patients with newly diagnosed glioblastoma....IPAX-2 (ClinicalTrials.gov Identifier: NCT05450744) is a Phase I dose escalation study to confirm safety profile of TLX101 in combination with external beam radiation therapy (EBRT) and temozolomide in front-line glioblastoma. 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 proof-of-concept Phase II study."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Telix International Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2022 ➔ Apr 2023

Enrollment open • Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

IPAX-1: 131I-IPA and Concurrent XRT in Recurrent GBM (clinicaltrials.gov) - P1/2 | N=10 | Completed | Sponsor: Telix International Pty Ltd | Active, not recruiting ➔ Completed | N=44 ➔ 10

Enrollment change • Trial completion • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate (PRNewswire-Asia) - "Telix Pharmaceuticals Limited...announces the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a Phase I study of TLX101 investigational therapy (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM)....Telix has now initiated the IPAX-2 study (ClinicalTrials.gov Identifier: NCT05450744) in Australian sites to confirm the safety profile of TLX101 as a front-line therapy in combination with standard of care treatment, ahead of progressing to a label-indicating Phase II/III study in a larger patient population, IPAX-3. The IPAX-2 study will run concurrently to the study in Chinese patients in the same disease setting."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

First Patient Dosed in Phase II 'IPAX-Linz' Study of TLX101 for Glioblastoma Therapy (PRNewswire) - "Telix Pharmaceuticals Limited...announces that a first patient has been dosed in a Phase II investigator-initiated study of TLX101 in combination with external beam radiation therapy (EBRT) in patients with recurrent high-grade gliomas (HGG), including glioblastoma multiforme (GBM)....The IPAX-Linz study, which is being led by Professor Josef Pichler at Kepler University Hospital in Linz, Austria, builds on data generated in the IPAX-1 study....IPAX-Linz will run concurrently with IPAX-2, which is evaluating TLX101 in combination with post-surgical standard of care comprised of EBRT and temozolomide in newly diagnosed (first line) GBM patients."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Final IPAX-1 Study Data Confirms Safety and Tolerability Profile for TLX101, Preliminary Efficacy Data (PRNewswire) - P1/2 | N=44 | IPAX-1 (NCT03849105) | Sponsor: Telix International Pty Ltd | "Telix Pharmaceuticals Limited...reports the final results from the IPAX-1 Ph I/II study of TLX101 therapy (4-L-[ 131I] iodo-phenylalanine, or 131I-IPA) in combination with external beam radiation therapy (EBRT) in recurrent glioblastoma multiforme (GBM)....Final data up to the completion of the post-study follow-up period confirms the study has met its primary objective, demonstrating the safety and tolerability profile of TLX101 at the dosing range tested. The study also delivered encouraging preliminary efficacy data for further evaluation, demonstrating a median overall survival (OS) of 13 months from the initiation of treatment in the recurring setting, or 23 months from initial diagnosis. Given that GBM has a median survival from initial diagnosis of 12-15 months, the overall survival improvement trend seen in this patient population clearly warrants further evaluation in a larger patient population."

P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

IPAX-1: phase 1/2 study of 131 I-iodo-phenylalanine ( 131 I‑IPA) combined with external radiation therapy as treatment for patients with relapsed glioblastoma (EANO 2022) - "There were no clinically relevant laboratory changes over time. Urinalysis, vital signs, and ECG did not show any clinically relevant changes from baseline. There were no notable differences in safety and tolerability between groups."

Clinical • P1/2 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2) (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Telix International Pty Ltd

New P1 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Telix Advances Development of Glioblastoma Therapy Program (PRNewswire) - "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....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."

New P1 trial • New P2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Telix Collaborates with Olivia Newton-John Cancer Research Institute on Brain Cancer Imaging Study (GlobeNewswire) - "Telix Pharmaceuticals Limited...announces that it has entered into a clinical data access agreement with the Olivia Newton-John Cancer Research Institute (ONJCRI) relating to a prospective clinical trial investigating the use of O-(2-[18F]fluoroethyl)-L-tyrosine or 18F-FET to image glioblastoma patients with positron emission tomography (PET) (FET-PET). 18F-FET is under development by Telix (referred to as TLX101-CDx) as a complementary diagnostic agent to its TLX101 glioblastoma therapeutic candidate. The FET-PET in Glioblastoma...is a prospective, multicentre study which aims to definitively establish the role of FET-PET in the management of glioblastoma..."

Licensing / partnership • CNS Tumor • Glioblastoma • Glioma • Oncology

IPAX-1 Late Breaking Oral Presentation at the Congress of Neurological Surgeons (CNS) Meeting (Yahoo Finance) - P1/2, N=44; IPAX- 1 (NCT03849105); Sponsor: Telix International Pty Ltd; “The data confirms the study has met its primary objective, demonstrating safety and tolerability of TLX101 at doses tested. The results also show overall survival (OS) of 15.97 months, to date, in the second line (recurrent) GBM setting. Six (6) out of 10 patients in the study are still alive and will be followed until one (1) year after dosing for the final OS calculation (May 2022).”

P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology

IPAX-1: 131I-IPA and Concurrent XRT in Recurrent GBM (clinicaltrials.gov) - P1/2; N=44; Active, not recruiting; Sponsor: Telix International Pty Ltd; Trial completion date: Dec 2021 ➔ Oct 2022; Trial primary completion date: Aug 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

[VIRTUAL] IPAX-1: Phase I/II study of 131I-iodo-phenylalanine combined with external radiation therapy as treatment for patients with glioblastoma multiforme. (ASCO 2020) - P1/2 | "131I-iodo-phenylalanine (131I-IPA) is a small-molecule amino acid derivative taken up by LAT-1 with designated orphan status in the United States and European Union for the treatment of GBM...IPAX-1 enrollments began in July 2019; the study will enroll up to 44 patients and is currently recruiting at five sites in Europe and Australia. Research Funding: Telix International Pty Ltd"

Clinical • P1/2 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

IPAX-1: 131I-IPA and Concurrent XRT in Recurrent GBM (clinicaltrials.gov) - P1/2; N=44; Active, not recruiting; Sponsor: Telix International Pty Ltd; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Brain Cancer • Glioblastoma • Oncology • Solid Tumor