Telix seeks European approval of glioma imaging agent
Company sees 'compelling opportunity' to widen access to imaging, treatment
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Telix Pharmaceuticals has submitted an application to European regulators seeking approval for TLX101-Px, the company’s experimental imaging agent designed to help guide treatment decisions in people with glioma.
“We see a compelling opportunity in Europe to broaden access to authorized targeted radiopharmaceuticals for brain cancer imaging and therapy, and as such this submission is an important milestone for Telix,” Kevin Richardson, CEO of diagnostics-focused Telix subsidiary Telix Precision Medicine, said in a company press release.
Telix has been working on a similar application seeking approval of TLX101-Px in the U.S. The company said it plans to submit that application to the U.S. Food and Drug Administration (FDA) soon.
“We have been able to utilize aspects of our FDA package to expedite the European filing, which has been submitted in accordance with a pre-defined date agreed with the regulator, with the U.S. resubmission to follow,” Richardson said.
Working with scans to monitor tumors
Glioma is a category of brain cancers caused by the uncontrolled growth of glia, a class of brain cells that normally support nerve function and protect the brain from damage. To diagnose glioma and monitor treatment response, clinicians commonly rely on imaging technologies such as MRI and PET scans.
PET scans work by injecting a radioactive tracer into the body. The tracer binds to specific cell types or biological markers, which then appear brighter on images produced by the scan. TLX101-Px, also known as O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET, is a new type of tracer that aims to highlight two proteins: LAT1 and LAT2 (L-type amino acid transporter types 1 and 2).
By identifying these proteins, the imaging agent aims to make it easier for clinicians to distinguish between tumors that have grown and tumors whose structure has changed due to damage from earlier treatments — a distinction that can be tricky to tease out with currently available imaging tech.
“PET imaging is already used in clinical practice in Europe for the evaluation of gliomas, and plays a critical role in treatment decision making,” said Philipp Lohmann, PhD, group leader in digital translational neuroimaging at Forschungszentrum Jülich research center in Germany. “This applies particularly in the post-therapy setting, where conventional MRI alone can be limited in its ability to distinguish tumor progression from treatment-related changes.”
Broadening access to TLX101-Px has the “potential to provide clinicians with greater biological insight, supporting more confident and timely management of patients with brain tumors,” Lohmann said.
Telix is developing the agent in parallel with a glioma treatment called TLX101-Tx (iodofalan 131I) that consists of a small molecule that binds to the LAT1 protein. The small molecule is attached to a piece of radioactive material. The therapy aims to deliver the toxic radioactive molecule directly to glioma cells expressing LAT1, killing them. Since TLX101-Px can identify tumors expressing the protein, the imaging agent may help guide treatment decisions with this experimental therapy in particular, according to Telix.
“The strategic value of this submission [seeking European approval of TLX101-PX] is particularly relevant to establishing widespread glioma imaging as part of our corresponding therapeutic development program,” Richardson said.
A Phase 3 clinical trial, IPAX BrIGHT (NCT07100730), is testing TLX101-Tx in addition to standard-of-care therapies against standard of care alone in people with recurrent glioblastoma, an aggressive form of glioma. That trial is recruiting participants at sites in Australia.
