ND CLEARANCE RECEIVED FROM THE US FOOD AND DRUG ADMINISTRATION
(FDA) FOR CHM 1101 (CLTX CAR T) FOR GLIOBLASTOMA

On August 20, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical-stage cell therapy company, reported that the US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for CHM 1101 (CLTX CAR T) for patients with recurrent/relapsed Glioblastoma (Press release, Chimeric Therapeutics, AUG 20, 2021, View Source [SID1234586748]).

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CHM 1101 (CLTX CAR T) is a novel CAR T cell therapy that uniquely utilizes Chlorotoxin as its tumour targeting domain. CHM 1101 has shown promising preclinical safety and efficacy and is currently being studied in a single site phase 1 clinical trial.

"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, COO 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."

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.

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 has not elicited adverse side effects when delivered intracranial and through IV 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