Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate

Melbourne (Australia) | 11 April 2023

Telix today 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).

The investigational new drug (IND) application was submitted by Telix’s partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The Phase I study is required to establish the safety profile of this therapeutic candidate in a Chinese patient population, thus enabling Chinese patients to be enrolled in Telix’s planned global pivotal registration trial for TLX101. This is the first of Telix’s investigational therapies to move into a clinical trial with Grand Pharma.

The IPAX-1 study of TLX101 ( Identifier: NCT03849105) met its primary objective demonstrating safety and tolerability profile of intravenous 131I-IPA administered concurrently with external beam radiation therapy (EBRT) in patients with recurrent GBM. The study also delivered encouraging preliminary efficacy data for further evaluation, demonstrating a median overall survival of 13 months from the initiation of treatment in the recurring setting, or 23 months from initial diagnosis.1

Telix has now initiated the IPAX-2 study ( 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.

Mr Zhou Chao, CEO Grand Pharma said, “China is a rapid adopter of new radiopharmaceutical theranostics, and the Chinese regulator NMPA – a leading, competent global authority – is increasingly familiar with this class of drug. With over 30,000 patients diagnosed with GBM in China annually,2 there is very high unmet medical need for new therapeutic options for this disease, which makes studies like this one critical.”

Dr David N Cade, CEO Telix Asia Pacific added, “Building on the successful IPAX-1 study of TLX101 therapy in patients with recurrent GBM, we are pleased to commence this follow-on study in newly diagnosed Chinese patients. Completion of this Phase I trial is critically important to the development of this asset, as it will enable Chinese patients to be included in the future global registration trial for TLX101 and potentially enable parallel regulatory submissions in Western markets and China. With our partner for Greater China, Grand Pharma, Telix’s goal is to provide new treatment options for this aggressive cancer with significant unmet medical need as efficiently as possible in this large market.”

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[1] Telix ASX disclosure 21 September 2022.

[2] Globocan 2020.