Chimeric Therapeutics Ltd (ASX:CHM) has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its application for CHM 1101 (CLTX CAR T) for patients with recurrent/relapsed Glioblastoma.
CHM 1101 (CLTX CAR T), a novel CAR T cell therapy that uniquely utilizes Chlorotoxin as its tumour targeting domain, has shown promising preclinical safety and efficacy and is currently being studied in a single site phase-I clinical trial.
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“Critical milestone”
Chimeric chief operating officer Jennifer Chow said: “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).
“Our first step will be to open new phase-I 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.”
With this foundational IND, Chimeric will also further advance plans for a phase 1 basket trial in solid tumours and a phase 2 registration trial in Glioblastoma.
Background
Chlorotoxin is derived from scorpion toxin, which 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 IV routes in brain cancer mouse models.
At the same time, it has been 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.