- Chimeric Therapeutics (CHM) receives FDA clearance for its investigational new drug for patients with progressive glioblastoma
- The company says its CHM 1191 drug has shown promising preclinical safety and efficacy and is currently being studied in a phase one clinical trial
- Chimeric says it will also further advance plans for a phase one trial in solid tumours and a phase two registration trial in glioblastoma
- Company shares are up 3.17 per cent, trading at 32.5 cents
Chimeric Therapeutics (CHM) has received FDA clearance for its investigational new drug for patients with recurrent and progressive glioblastoma.
Chimeric’s CHM 1191 is a novel CAR T cell therapy that uses Chlorotoxin as its tumour targeting domain. Chlorotoxin comes from scorpion toxin, which binds to unique targets on brain cancer cells.
The company says its CHM 1191 drug has shown promising preclinical safety and efficacy and is currently being studied in a phase one clinical trial.
The cells were proven to not target healthy cells and no adverse side effects were recorded when delivered within the skull and through IV routes in brain cancer mouse models. At the same time, it has been proven to bind to a higher percentage of glioblastoma tumours than immunotherapies against other targets.
Chimeric says it will also further advance plans for a phase one trial in solid tumours and a phase two registration trial in glioblastoma.
Jennifer Chow, Chief Operating Officer of Chimeric Therapeutics, said the FDA clearance was a critical milestone for the company, enabling it to expand its development program for the CHM 1191 drug.
“Our first step will be to open new phase one clinical trial sites under the current study protocol,” Ms Chow said.
“This will allow us to accelerate the phase one CHM 1101 clinical trial, which will be particularly important as we head towards the expansion phase of the protocol.”
Chimeric said it will continue to be actively engaged in further developing its oncology pipeline with new and novel cell therapy assets, to assist patients living with cancer.
Company shares were up 3.17 per cent, trading at 32.5 cents at 12:37 pm AEST.