Chimeric Therapeutics completes further dosing in brain cancer clinical trial

Pioneering Sydney-headquartered cell therapy specialist Chimeric Therapeutics (ASX:CHM) has achieved another key milestone in its development of a new cancer treatment.

The company has achieved an important requirement in its current trial program for its unique CHM 1101 development with the successful treatment of a third participant.

This milestone means Chimeric has achieved the necessary level of dosage to complete the fourth and final planned dose escalation cohort.

In-depth study

The current Phase 1A study involves dose escalation which provides an in-depth evaluation of the safety and maximum tolerated dose of CHM 1101 in patients with recurrent or progressive glioblastoma (GBM).

The Phase 1A study enrolled clinical trial participants with MMP2+ recurrent or progressive GBM across four dose levels, with the ultimate aim of establishing recommended dosing levels for a Phase 2 trial.

Brain cancer a significant problem in US

It is estimated that 18,990 deaths (11,020 men and 7,970 women) from primary cancerous brain and CNS tumours will occur in the US in 2023.

The American Cancer Society’s estimates for brain and spinal cord tumours in the US for 2023 include both adults and children. About 24,810 malignant tumours of the brain or spinal cord (14,280 in males and 10,530 in females) will be diagnosed.

Chimeric’s CHM 1101 is a novel and promising CAR T therapy developed for the treatment of patients with solid tumours. The company has already obtained positive data from the investigator-initiated phase 1A trial of patients treated in the first two dose levels of the trial.

Next stage underway

Jennifer Chow, chief executive officer and managing director of Chimeric Therapeutics, said the company has now advanced development of CHM 1101 to a Phase 1B clinical trial currently open for enrolment at the Sarah Cannon Transplant & Cellular Therapy Program at St. David’s South Austin Medical Centre in Austin, Texas.

“We are very pleased that the Phase 1A City of Hope clinical trial has completed dose escalation at all four planned dose levels,” Ms Chow said.

“We look forward to providing an update on the safety and efficacy from the trial before the end of the year.”

Chimeric is aiming to release an update on the clinical safety and activity from the CHM 1101 clinical program. Based on a favourable review of the results of that assessment, Part B of the trial, a dose expansion cohort, will be opened to enrol 12 to 26 additional participants.

Upon successful completion of the Part B dose expansion cohort, the company will design and initiate a registrational trial.

Licenced global rights

CHM 1101 is a first-in-class CAR T cell therapy that uniquely utilises chlorotoxin (CLTX), a 36-amino acid peptide derived from the deathstalker scorpion venom as its tumour targeting domain.

CHM 1101 has been shown to more specifically and broadly target GBM cells than other immunotherapy targets like HER2, EGFR and IL13, through recognition of a receptor complex composed of membrane-bound matrix metalloprotease 2.

Chimeric has licensed the exclusive global rights to intellectual property covering the chlorotoxin CAR-T cells from City of Hope, one of the largest cancer research and treatment organisations in the US.