IPAX-1 (TLX101 for Glioblastoma Therapy) Clinical Trial Update

Melbourne (Australia) – 21 June 2021. Telix announces preliminary safety data from the IPAX-1 Ph I/II study, with a follow-on study being planned in front-line therapy.

Telix has today announced that patient recruitment into the IPAX-1 Ph I/II study of TLX101 (4-L-[¹³¹I] iodo-phenylalanine) in combination with external beam radiation therapy in recurrent glioblastoma multiforme (GBM), will be closed. Interim analysis of safety and preliminary efficacy is sufficiently encouraging to warrant study in front-line therapy, where radiation therapy is more extensively used. As such, the Company has decided to cease recruitment after dosing a tenth patient in this recurrent disease (second-line) treatment setting.

TLX101 is under evaluation for the treatment of recurrent glioblastoma multiforme (GBM) at five sites in Australia and Europe (IPAX-1 study details can be accessed here: NCT03849105). Recurrent GBM is a highly aggressive cancer that progresses rapidly, and for which there are few effective treatment options. TLX101 is a systemically administered molecularly-targeted radiation (MTR) investigational asset that targets L-type amino acid transporter 1 (LAT-1), which is typically over-expressed in GBM. TLX101 has been granted orphan drug designation in the US and Europe.

Telix Chief Medical Officer, Dr. Colin Hayward stated, “We are highly encouraged by the safety profile of this single arm dose-escalation study, where different dosing regimens have been combined with external radiation therapy. Whilst a small study of ten patients, promising overall survival and anti-tumour response observed from longitudinal imaging supports the decision to progress this candidate into an earlier line of therapy. A follow-on study is currently in planning to accelerate the development of TLX101 in this important therapy area with high unmet medical need.”

Telix will release a complete set of safety and efficacy data upon completion of the study report.

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