FDA approves early-stage trial for Chimeric CAR-T

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Clinical-stage cell therapy company Chimeric Therapeutics (ASX:CHM) has announced that the US FDA has cleared an Investigational New Drug (IND) application for CHM 1101 for patients with recurrent or relapsed Glioblastoma.

CHM 1101 (CLTX CAR-T) is a novel CAR-T cell therapy that utilises chlorotoxin as its tumour targeting domain.

The company said CHM 1101 has shown promising preclinical safety and efficacy and is currently being studied in a single site phase 1 clinical trial.

Chlorotoxin is derived from scorpion toxin. This binds preferentially to unique targets on brain cancer cells. CLTX CAR T cells do not target healthy cells and have not elicited adverse side effects when delivered intracranial and through intravenous routes in brain cancer mouse models.

"At the same time, it has shown to bind to a higher percentage of Glioblastoma tumours than immunotherapies against other targets. Glioblastoma is the most common and aggressive type of brain tumour, with overall survival following first recurrence estimated at only 5-8 months," said the company.

“The FDA clearance of our IND is a critical milestone for Chimeric as it enables us to expand the development program for CHM 1101 (CLTX CAR T),” said Jennifer Chow, the chief operating officer of Chimeric Therapeutics.

“Our first step will be to open new phase 1 clinical trial sites under the current study protocol. This will allow us to accelerate the phase 1 CHM 1101 clinical trial, which will be particularly important as we head towards the expansion phase of the protocol.”

Chimeric said it will also further advance plans for a phase 1 basket trial in solid tumours and a phase 2 registration trial in Glioblastoma.