Chimeric Therapeutics receives ethics approval for phase 1B study in patients with brain cancer
Preclinical trials of CHM 1101 have demonstrated “potent” anti-tumour activity in brain cancer models.
Chimeric Therapeutics (ASX: CHM) has received ethics approval for a phase 1B clinical trial evaluating its CHM 1101 candidate in patients with recurrent or progressive brain cancer.
CHM 1101 is a novel chimeric antigen receptor technology (CAR-T) therapy that has been designed to target solid tumours.
The therapy uses a 36-amino peptide that has been derived from deathstalker scorpion venom, CLTX, which makes up the tumour targeting component.
Preclinical research using CHM 1101 has shown “potent” anti-tumour activity against glioblastoma multiforme (GBM), which is the most aggressive form of brain cancer.
Currently, there are limited options for patients with this disease, which has a median survival of less than one year.
Ethics approval has now been secured to begin a multi-site phase 1B clinical study in patients with GBM.
Commenting on the latest approval, Chimeric chief medical officer Dr Jason Litten said expanding the clinical program to additional sites was critical to the company’s mission to deliver its therapeutics to patients who need them.
Two-part study
He added the study will be undertaken in two-parts, which will position Chimeric to “move rapidly” into the dose expansion cohort upon positive clinical data from the phase 1 trial at the end of 2023.
Part A of the trial will treat three-to-six patients and complete the phase 1 dose escalation/confirmation study that began at the City of Hope Cancer Centre in the United States.
At the end of 2023, Chimeric will undertake an assessment of the clinical efficacy and safety data from the phase 1 dose escalation/confirmation cohort.
If the results support further development, part B of the trial will begin.
Part B will involve a dose expansion cohort and enrol 12-26 patients with recurrent or progressive GBM.
This expansion cohort will fall under the phase 2 dosing plan and be assessed for safety and efficacy.
Then, if results from this work are positive, a registration trial will be initiated in alignment with regulatory feedback.