On February 8, 2022 Chimeric Therapeutics (ASX:CHM, "Chimeric"), a clinical-stage cell therapy company and the ASX leader in cell therapy, reported that encouraging initial data for the 2nd dose cohort of the CLTX CAR T phase 1 dose escalation study for patients with recurrent/progressive glioblastoma at the City of Hope, one of the largest cancer research and treatment organizations in the United States (Press release, Chimeric Therapeutics, FEB 8, 2022, View Source [SID1234607813]).
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In the 2nd dose cohort, dual routes of intratumoral and intraventricular CLTX CAR T cell administration were introduced at a total dose of 88 X 106 CLTX CAR T cells. City of Hope developed and manufactured the therapy.
Positive initial safety was seen as patients generally well tolerated the dual routes (intratumoral and intraventricular) of CLTX CAR T cell administration introduced in this dose cohort. As previously announced, all patients advanced past the 28-day follow-up without experiencing dose limiting toxicities. Additionally, an encouraging activity signal was demonstrated with 2/3 evaluable patients treated achieving local stability of disease.
Additional insights into this cohort are anticipated to be presented at a scientific congress as the trial progresses.
The study is now enrolling patients in the 3rd dose cohort, which will administer CLTX CAR T cells to patients through the dual routes of administration at an increased total dose of 220 X 106 CLTX CAR T cells.
"This preliminary data is encouraging as it demonstrates safety with dual routes of administration. We now look forward to advancing the trial to higher dose levels which may provide more therapeutic benefit to patients," said Behnam Badie, M.D., Professor and Chief, Division of Neurosurgery; Director, Brain Tumor Program, Department of Surgery, City of Hope.
Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper.
ABOUT CHLOROTOXIN CAR T
Chlorotoxin CAR T (CLTX CAR T) cell therapy is a first and best in class CAR T cell therapy that has the potential to address the high unmet medical need of patients with recurrent/ progressive glioblastoma. Research to develop the intellectual property covering this CAR T cell therapy took place at City of Hope.
CLTX CAR T cell therapy uniquely utilizes chlorotoxin (CLTX), a peptide derived from scorpion toxin, as the tumour-targeting component of the chimeric antigen receptor (CAR). CLTX and CLTX CAR T cells have been shown in preclinical models to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13.
In preclinical models, CLTX CAR T cells also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumor recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile.