ASX-listed cell therapy company Chimeric Therapeutics has received ethics approval to start a multi-site phase 1B clinical trial of the company’s CHM 1101 cell treatment for patients with recurrent or progressive glioblastoma (GBM).
The disease often starts in the spinal cord or brain and becomes a fast-growing tumour. It is regarded as the most aggressive form of brain cancer.
Chimeric says the new approval development will see a two-part clinical study enrolling patients across multiple clinical trial sites in the United States.
The first part of the trial will treat between three and six patients and complete the first-phase CHM 1011 dose escalation study that was previously started at California’s City of Hope Cancer Centre. At the end of the year, an assessment will be made on the trial cohort and should it be deemed a success, the company will proceed with the second stage – a further dose expansion designed to include between 12 and 26 patients living with GBM.
Chimeric Therapeutics chief medical officer Dr Jason Litten said: “Expanding our clinical program to additional sites is critical to our mission to deliver our medicines to the patients who need them. The two-part trial design also ensures that we are positioned to move rapidly into the dose expansion cohort upon a positive clinical assessment of the Phase 1 data at the end of 2023.”
Melbourne-based Chimeric has the exclusive global rights to intellectual property covering CHM 1101, which is also known as the chlorotoxin (CLTX) CAR T cells. The company believes its cellular therapies have the promise to cure cancer, not just delay disease progression.
CAR T therapy involves taking T cells from a patient’s blood and adding a receptor called a chimeric antigen receptor (CAR) to help the T cells attach to the cancer cell.
Chimeric believes CLTX CAR T is a first-in-class therapy with the potential to address the unmet medical need of patients with recurrent or progressive glioblastoma. CLTX previously grabbed headlines due to its innovative origin story, as it is a peptide derived from scorpion toxin now being used as the tumour-targeting component of the CAR.
The new trial follows the successful completion in March of the fourth dose of the treatment, which concluded without presenting any toxic effects as part of a clinical trial.
Should the current stage of the trial be deemed a success, a registration trial will be the next cab off the rank in line with regulatory procedure.
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