ASX Health Stocks: Telix’s brain-cancer imaging agent Pixclara handed to FDA for review

Telix has filed a New Drug Application with the FDA for Pixclara
Chimeric starts Phase 1/2 trial for CHM CDH17
Pixclara and CHM CDH17 address major gaps in brain-cancer imaging and treatment

Telix submits New Drug Application with FDA

Telix Pharmaceuticals (ASX:TLX) has filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for its brain-cancer imaging agent, TLX101-CDx (Pixclara).

The PET (Positron Emission Tomography) imaging agent has already been recognised by the FDA with Orphan Drug and Fast Track designations, which should help speed up the NDA review process.

The agent is designed to better identify progressive or recurrent gliomas, a type of brain cancer.

Currently, there are no FDA-approved PET agents specifically for brain-cancer imaging available in the US, despite Pixclara being included in international guidelines.

The need for improved imaging is critical due to the high mortality rates associated with gliomas, and the urgency required in treatment decisions.

Telix’s Pixclara helps provide clearer images for diagnosing brain cancer and help doctors plan better treatments.

It’s also being developed to work alongside Telix’s new drug, TLX101, which uses targeted radiation to treat cancer.

“Telix’s filing of this NDA for Pixclara is an important milestone, reflecting our commitment to improved and accessible neuro-oncology imaging in the US,” said Kevin Richardson, CEO of Telix Precision Medicine.

“This will take us one step closer to commercial availability in 2025, subject to FDA approval.”

Meanwhile, gliomas, which originate from brain glial cells, are the most common type of brain tumour and account for a significant portion of all malignant brain tumours.

Each year in the US, about 22,000 new cases of glioblastoma are diagnosed, with current treatments including surgery, radiotherapy, and chemotherapy – although recurrence is common and survival rates remain low.

First patient dosed in Chimeric’s Phase 1/2 Clinical Trial

Chimeric Therapeutics (ASX:CHM) has launched its first clinical trial for CHM CDH17, an advanced CAR-T cell therapy designed to target and treat gastrointestinal cancers.

This Phase 1/2 trial, now recruiting patients at various cancer centres across the US, focuses on individuals with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours.

The initial patient was treated at the Sarah Cannon Research Institute in Nashville, Tennessee.

The trial is divided into two stages: Phase 1 will determine the optimal dose of CHM CDH17 and evaluate its safety, while Phase 2 will further assess its effectiveness in specific cancer types.

The clinical program is built on earlier promising preclinical studies published in Nature Cancer in March 2022, which demonstrated that CHM CDH17 could eradicate established tumours in seven cancer models without causing damage to normal tissues.