Telix Pharmaceuticals Touts Encouraging Data From Investigational Radiation Therapy In Relapsed Brain Cancer Patients

Telix Pharmaceuticals Limited TLX on Tuesday released 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 study.

IPAX-Linz is a single-arm Phase 2 investigator-initiated trial evaluating the safety, tolerability, and preliminary efficacy of TLX101 therapy in combination with external beam radiation therapy (EBRT).

TLX101 (131I-iodofalan or 131I-IPA) is a systemically administered targeted radiation therapy that targets L-type amino acid transporter 1, which is typically over-expressed in glioblastoma.

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.

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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 the initial diagnosis.

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 the initial diagnosis.

In comparison, recurrent glioblastoma patients treated with EBRT alone have a reported median survival of 9.9 months from treatment.

Eight patients were included in the study with adaptive dosing of intravenous TLX101 up to the administered activity of 4 GBq before and up to 2 GBq after second-line EBRT, administered in sequential injections.

Preliminary results from IPAX-Linz will be presented at the Nuclear Medicine and Neurooncology (NMN) Symposium, which will take place in May.

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 enrollment 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 to commence the study at U.S. sites in H2 2025.

Professor Josef Pichler, Kepler University Hospital, Austria, Principal Investigator, 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.”

William Blair writes, “We are intrigued by the overall survival data generated from the Phase II IPAX-Linz study of TLX101, and we believe it warrants further investigation. The data also corroborated the results generated from Phase I IPAX-1 study, which demonstrated a median survival of roughly 12 to 13 months and appear to be numerically longer than recurrent glioblastoma patients receiving only external beam radiation therapy (roughly 10 months).”

“From a stock perspective, we continue to hold a bullish view on Telix shares,” analyst Andy Hsieh writes.

Price Action: TLX stock is down 0.30% at $16.77 at the last check Wednesday.

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