Chimeric (ASX: CHM) reports encouraging clinical data from CLTX CAR T Phase 1A trial; shares soar - Kalkine Media

Highlights

• The patients under the CLTX CAR T clinical trials achieved a 55% DCR, exceeding 20-37% historical rates.
• The achieved median survival is around ten months among the patients that achieved disease control.
• In two patients, the survival exceeded 14 months, while the follow up is ongoing for three patients.
• Phase 1B clinical trial has commenced, and CHM intends to advance the study to a dose expansion cohort in the upcoming year.

Shares of Chimeric Therapeutics Limited (ASX: CHM) rallied as much as 68% to an intraday high of AUD 0.047 apiece on Monday (23 October 2023) early morning trade after the company reported encouraging results from Phase 1A CLTX CAR T clinical trial.

The company has shared positive preliminary clinical data for CLTX CAR T in recurrent, late-stage, pretreated glioblastoma patients. The results demonstrated that patients treated across all four dose levels of the trial have shown a 55% disease control rate (DCR) as against historical DCR of  20-37% for patients treated in 2nd line.

Around 9.9 months, median survival was observed in patients that achieved disease control. Generally, after first line therapy, the expectation for patients survival are nearly seven months. The results highlighted that two patients have shown survival over 14 months, one exceeding 18 months survival and three alive and in follow up.

The Phase 1A clinical trial results demonstrate the safety and effectiveness of CLTX CAR T in the treatment of glioblastoma

Data source: Company update

The company informed that the Phase 1B clinical trial is ongoing and is currently open for enrolment. This two-part clinical trial is being conducted under a US IND and is a two-part clinical trial.

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Phase 1A trial for CLTX CAR T was undertaken at City of Hope in the United States and enrolled participants with MMP2+ recurrent or progressive GBM across four dose levels. The trial is going on and continues to be evaluated and monitored.

The interim results indicate that generally CLTX CAR T was well tolerated, with no Cytokine Release Syndrome (CRS), no dose limiting toxicities (DLT’s) and no Tumor Lysis Syndrome (TLS).

Data Source: Company update

Under Part A of the trial, 3-6 clinical trial participants will be enrolled at 440 X 10⁶ CHM 1101 cells. The trial will involve the highest dose tested in the Phase 1A clinical trial at City of Hope.

The development of Part B of the trial will be dependent upon the safety and efficacy seen in the Phase 1A City of Hope clinical trial’s interim results. Part B will be an expansion cohort, which would assist in confirming the recommended Phase 2 dose and administration schedule.

Part B will see the enrolment of an additional 12-26 patients.

Following the dose expansion cohort completion, the further plan is to design and begin a registrational trial in line with regulatory feedback and guidance.