Clinical Trials Arena

Daily Newsletter

08 August 2023

Daily Newsletter

Australian biopharmaceutical company Telix has dosed the first newly diagnosed glioblastoma patient in the Phase I IPAX-2 study of TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA).

TLX101 is being trialled in the dose-escalation study in combination with post-surgical standard-of-care treatment.

The trial aims to confirm TLX101's safety profile together with external beam radiation therapy (EBRT) and temozolomide in front-line glioblastoma.

It will recruit 12 patients across six sites across Europe, New Zealand and Australia.

TLX101 previously demonstrated safety and tolerability in Telix's IPAX-1 study, in which the drug was administered intravenously in parallel with second-line EBRT.

An overall survival of 13 months from the start of treatment in the recurring setting, or 23 months from initial diagnosis, was also observed.

Telix chief medical officer Dr Colin Hayward said: “Commencing this study supports Telix’s goal to expedite new radiopharmaceutical therapies in areas of unmet need.

“With IPAX-2, we are taking the development of TLX101 into front-line glioblastoma for the first time, and excited to see the potential impact of targeted radiation in patients after initial surgery.”

If TLX101’s interaction profile and safety remain suitable in this setting, Telix will begin a proof-of-concept Phase II study.

The drug targets a L-type amino acid transporter 1 (LAT-1) membrane protein that is highly expressed in glioblastoma patients.

To identify such patients, Telix’s TLX101-CDx (18F-FET) positron emission tomography (PET) agent is used for imaging.

In addition, the agent provides baseline and follow-up information on tumour response and progression.

TLX101 has previously received orphan drug designation in Europe and the US for glioblastoma.

Telix is also investigating the drug in the recurrent setting in IPAX-Linz, an investigator-initiated Phase II trial.

Last month, the company dosed the first patient in its Phase Ib trial of TLX250 in combination with Merck’s DNA-dependent protein kinase (DNA-PK) inhibitor, peposertib (M3814).

Healthcare companies are hesitant to invest in the metaverse

The COVID-19 pandemic pushed the healthcare industry to rapid digitalization. Increased use of telehealth, telepresence systems, remote diagnostics, predictive AI, and wearable technology is changing how healthcare is delivered and improving patient outcomes. Emerging technologies such as AR and VR are becoming increasingly routine for professional training, surgical assistance, and treatment of psychological and neurological disorders. In the pharma and medical devices industries, AR, VR, and AI are rapidly accelerating drug discovery and manufacturing and generating supply chain efficiencies. New digital opportunities will look to build upon disruptive technologies. However, affordability is a limiting factor to widespread adoption. Per GlobalData estimates, the metaverse market is expected to grow at a CAGR of more than 33% between 2023 and 2030. Although metaverse technologies could reinvent healthcare approaches and bring new experiences to healthcare providers and patients, adoption is still at an early stage. There are currently few use cases in the healthcare industry. The metaverse needs to overcome major challenges for healthcare, including regulation and data privacy concerns. Evidence of proven use cases and participation by a critical mass of users are imperative to drive a shift in metaverse investment.