AUS
NZ
UK
CA
USA
FRA
GER
ESP
ITA
NLD
PRT
SWE
GRC
IND
POL
BRA
ZAF
RUS
CHN
UAE
Telix Pharmaceuticals (ASX:TLX) has made significant progress in its efforts to enhance brain cancer diagnostics. The company recently filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for TLX101-CDx (Pixclara), an innovative PET (Positron Emission Tomography) imaging agent designed to improve the detection of progressive or recurrent gliomas, a type of brain cancer. This filing is a pivotal step in advancing Pixclara towards potential commercial availability.
Pixclara has already received Orphan Drug and Fast Track designations from the FDA, which are expected to expedite the review process. Currently, there are no FDA-approved PET agents specifically for brain-cancer imaging in the US, despite Pixclara being acknowledged in international guidelines. The need for enhanced imaging solutions is pressing due to the high mortality rates associated with gliomas and the critical nature of timely treatment decisions.
Telix’s Pixclara aims to provide clearer imaging for diagnosing brain cancer, thereby assisting doctors in devising more effective treatment plans. The agent is also being developed to complement Telix’s new therapeutic drug, TLX101, which utilizes targeted radiation for cancer treatment.
Kevin Richardson, CEO of Telix Precision Medicine, highlighted the significance of the NDA filing, noting, “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.” The goal is to bring Pixclara to commercial availability by 2025, pending FDA approval.
Chimeric Therapeutics (ASX:CHM) has also reached a significant milestone with the initiation of its Phase 1/2 clinical trial for CHM CDH17, an advanced CAR-T cell therapy targeting gastrointestinal cancers. This trial, now recruiting patients across various cancer centers in the US, aims to address advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumors.
The first patient in the trial was treated at the Sarah Cannon Research Institute in Nashville, Tennessee. The trial is structured in two stages: Phase 1 will determine the optimal dosage of CHM CDH17 and assess its safety, while Phase 2 will focus on evaluating its effectiveness for specific cancer types.
Chimeric’s clinical program builds on promising preclinical studies published in Nature Cancer in March 2022, which demonstrated that CHM CDH17 could effectively target and eradicate established tumors across seven cancer models without harming normal tissues.
These advancements by Telix Pharmaceuticals and Chimeric Therapeutics represent important steps forward in the fight against cancer, with both companies making strides in developing new diagnostic and therapeutic options for patients.
