Cell therapy company Chimeric Therapeutics (ASX:CHM) says two CLTX CAR-T abstracts will be presented at the Society for Neuro-Oncology (SNO) 27th annual scientific meeting.
The company said the abstracts have shown positive results from its CLTX CAR-T phase 1 clinical trial.
Abstract CTIM-29, 'Clinical evaluation of chlorotoxin-directed CAR-T cells for patients with recurrent glioblastoma', provides insight into the initial clinical data for CLTX. Abstract EXTH-10, 'Exploration of a novel toxin-incorporating CAR-T cell: how does chlorotoxin recognize glioblastoma cells?', expands on the translational understanding of Chlorotoxin (CLTX) activity.
Chimeric said the clinical data released in abstract CTIM-29 is from the ongoing CLTX CAR-T phase 1 clinical trial in patients with MMP2+ recurrent or progressive glioblastoma.
The data focuses on the four patients enrolled in dose level 1 of the trial, treated with 44 X 106 CLTX CAR-T cells through a single route of intratumoral administration. Dose escalation in this trial is planned across four dose levels to a total dose of 440 X 106 CLTX CAR T cells administered through dual intratumoral and intraventricular routes of administration.
The company said that in patients treated at dose level 1, a disease control rate of 75 per cent was shown as three out of the four patients treated achieved a best response of stable disease assessed by RANO (response assessment in neuro-oncology).
The CLTX CAR-T cells were generally well tolerated and none of the patients experienced a dose-limiting toxicity. One patient experienced a grade 3 cerebral edema that was only possibly attributed to the CAR-T cells. Cerebral edema is an adverse event commonly observed in patients with glioblastoma.
The company said bioactivity of the cells was also demonstrated as liquid biopsy detected persistent CLTX CAR-T cells in the tumour cavity throughout treatment.
Chimeric’s CEO and managing director Jennifer Chow said, “These initial CLTX CAR-T clinical data, while early, are highly encouraging as they demonstrate that CLTX CAR T cells are eliciting disease control in recurrent glioblastoma even at the lowest, sub-therapeutic dose level. Achieving disease control in 3 of the 4 patients treated at this first dose level, along with the generally well-tolerated safety profile that was demonstrated, provides us with great enthusiasm for progressing the trial through the higher dose levels and dual routes of administration.”
The translational data available in abstract EXTH-10 focuses on the precise composition and structure of the cell surface complex recognized by CLTX CAR-T, confirming that the correlation between MMP-2 expression and CLTX binding supports the rationale for exploring MMP-2 as a correlative marker for response to CLTX CAR T in Phase 1 studies.