Chimeric Therapeutics Ltd (ASX:CHM) welcomes initiation of the fourth dose cohort of City of Hope’s phase 1 clinical trial evaluating the safety and tolerability of Chimeric’s CHM 1101 (CLTX CAR T) cell therapy.
The first patient in the fourth dose cohort in the phase 1 clinical trial in recurrent/progressive glioblastoma has received dosing at City of Hope Cancer Center in the US.
This cohort will see patients treated at a total dose of 440 X 106 CHM 1101 (CLTX CAR T cells) through dual routes of intratumoral and intraventricular administration.
Progression to this level follows the successful completion of the third dose cohort without any dose-limiting toxicities in January 2023.
“Exciting to see progress”
Chimeric’s chief medical officer Jason B Litten MD said, “It is exciting to see the progress on this potentially transformative new treatment for patients with highly aggressive brain tumours.
“Based on this clinical experience, Chimeric looks forward to building upon and expanding this program to deliver new medicines for cancer patients.”
Shares are 4.35% higher on the ASX intraday to A$0.072.
Study objectives
City of Hope, one of the largest cancer research and treatment organizations in the US, initiated and is leading, the Phase 1A CHM 1101 (CLTX CAR T) cell therapy clinical trial.
The Phase 1A study aims to enrol 18-36 patients with MMP2+ recurrent or progressive GBM across four dose levels.
Study objectives are to evaluate the safety and efficacy of CLTX CAR T and to establish recommended dosing for a phase 2 trial.
Chimeric has licensed the exclusive global rights to intellectual property covering the chlorotoxin (CLTX) CAR-T cells.
About Chlorotoxin CAR T
Chlorotoxin CAR T (CLTX CAR T) is a first-in-class CAR T therapy that has the potential to address the high unmet medical need of patients with recurrent/progressive glioblastoma.
CLTX CAR T uniquely utilizes chlorotoxin (CLTX), a peptide derived from scorpion toxin, as the tumour-targeting component of the chimeric antigen receptor (CAR) which has been shown in pre-clinical models to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13.
In preclinical models, CLTX CAR T also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumor recognition of normal human cells/tissues, thus supporting a potentially optimal safety and efficacy profile.
About Chimeric
Chimeric Therapeutics, a clinical-stage cell therapy company and an Australian leader in cell therapy, is focused on bringing the promise of cell therapy to life for more patients with cancer.
The company believes that cellular therapies have the promise to cure cancer, not just delay disease progression.
To bring that promise to life for more patients, Chimeric’s world-class team of cell therapy pioneers and experts is focused on the discovery, development and commercialization of the most innovative and promising cell therapies.
Chimeric continues to be actively engaged in further developing its oncology pipeline with new and novel cell therapy assets that will bring the promise of cell therapy to life for more patients with cancer.
CHM 1101 (CLTX CAR T) therapy
CHM 1101 (CLTX CAR T) is a novel and promising CAR T therapy developed for the treatment of patients with solid tumours. CHM 1101 is being studied in a phase 1 clinical trial in recurrent/progressive glioblastoma.
Initial positive data has been presented on patients treated in the first two dose levels of the trial. Additional work is being undertaken to expand CLTX to additional solid tumours, beginning with metastatic melanoma.
CHM 2101 is a novel, third-generation CDH17 CAR T invented at the world-renowned cell therapy centre, the University of Pennsylvania. Preclinical evidence for CHM 2101 was published in March 2022 in Nature Cancer.
CHM 2101 (CDH17 CAR T) is in pre-clinical development with a planned phase 1 clinical trial in gastrointestinal tumours.