On November 22, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric"), a clinical-stage cell therapy company and the ASX leader in cell therapy, reported to highlight key additional data released with the final presentation of two CLTX CAR T abstracts at the Society for Neuro-Oncology (SNO) 26th annual scientific meeting (Press release, Chimeric Therapeutics, NOV 22, 2021, View Source [SID1234595874]).
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Abstract CTIM-29, "Clinical evaluation of chlorotoxin-directed CAR T cells for patients with recurrent glioblastoma" provides insight into the initial clinical data for CLTX while abstract EXTH-10, "Exploration of a novel toxin-incorporating CAR T cell: how does chlorotoxin recognize glioblastoma cells?" expands on the translational understanding of Chlorotoxin (CLTX) activity.
The clinical data presented in abstract CTIM-29 is from the ongoing CLTX CAR T phase 1 clinical trial in patients with MMP2+ recurrent or progressive glioblastoma. The data focuses on the four patients enrolled in dose level 1 of the trial, treated with 44 X 106 CLTX CAR T cells through a single route of intratumoral administration. Dose escalation in this trial is planned across four dose levels to a total dose of 440 X 106 CLTX CAR T cells administered through dual intratumoral and intraventricular routes of administration
Of significant note, during the final presentation MRI scans presented of patient 487 demonstrated no recurrence of tumour in the left frontal lobe where CLTX CAR T cells were infused, two months after the CLTX CAR T cell infusion. Tumour progression was seen only in the left temporal lobe which did not receive CLTX CAR T infusion. Like all patients in this dose level, patient 487 received a dose of 44 X 106 CLTX CAR T cells through a single intratumoral route of administration. LEVEL 3, 62 LYGON STREET CARLTON VIC 3053 AUSTRALIA
This finding, that tumour recurrence was prevented in the area where the CLTX CAR T cells were infused and tumour progression occurred in areas away from where the CLTX CAR T cells were infused, is important as it suggests that the dual routes of administration (intratumoral and intraventricular) of the CLTX CAR T cells in dose levels 2-4 may provide additional hope for patients. In the initial abstract presentation of patients treated at the 1st dose level, a disease control rate of 75% was shown as 3 out of the 4 patients treated achieved a best response of stable disease assessed by RANO criteria. Additional details provided within the final presentation demonstrated that the disease control observed was durable for approximately 5-8 weeks.
The final presentation of the CLTX CAR T CTIM-29 abstract also provided additional insight into the generally well tolerated adverse event profile of CLTX CAR T, showing that there were no CRS events, an adverse event often associated with CAR T cell therapy. Confirmation that the one grade 3 cerebral edema event was only possibly attributed to the CAR T cells was also presented. Cerebral edema is an adverse event commonly observed in patients with glioblastoma.
Chimeric’s CEO and Managing Director Jennifer Chow said: "Being able to see tumour control where the CLTX CAR T cells were administered in the brain and tumour progression where they were not administered is very promising – particularly at this low initial dose. That, in addition to the durability of the disease control for up to 8 weeks gives us great reason for optimism as we progress to more active dose levels with dual routes of administration."
In addition, the presentation of abstract EXTH-10 provided early confirmation of the role of MMP-2 expression in CLTX CAR T tumour recognition and killing. Data presented showed that MMP-2 expression levels increased with tumour grade and that CLTX CART T cells preferentially kill tumour target cells with higher MMP-2 expression, suggesting that CLTX CAR T may be effective even against the most aggressive cancers.
Within the presentation, early staining of a melanoma cell line was also presented confirming strong MMP-2 expression and providing early support for expanding the clinical development program for CLTX CAR T into additional solid tumours, including melanoma. LEVEL 3, 62 LYGON STREET CARLTON VIC 3053 AUSTRALIA
About the CLTX CAR T (CHM1101) Clinical Trial:
The CLTX CAR T phase 1 clinical trial is currently in progress at a single site in California with plans to expand to a multi-site trial in 2022. The design is a single arm, open label trial in patients with MMP2+ recurrent or progressive glioblastoma.
The primary endpoints of the trial are to assess the safety of CLTX CAR T cells, determine the maximum tolerated dose schedule and a recommended Phase 2 dosing plan. Secondary endpoints include bioactivity and efficacy measures.
The trial is designed with 4 dose levels ranging from 44 X 106 to 440 X 106 CLTX CAR T cells and studies both single and dual routes of administration of cells. Dose level 1 was completed with no dose limiting toxicities in April 2021.
Investor webinar
Chimeric Therapeutics CEO and Managing Director Jennifer Chow will hold an investor webinar today, Monday 22 November 2021, at 11:30am AEDT to elaborate on this announcement and take questions.
Click the link below to register: View Source
After registering, you will receive a confirmation email about how to join the webinar. A recording of the webinar will be available at the same link shortly after the conclusion of the session.