Carisma: Data from Phase 1 Clinical Trial of CT-0508 at 8th Annual CAR-TCR Summit

Group 2 data available to date support primary safety and feasibility endpoints of single-day bolus dosing of CT-0508  

New translational analyses combining group 1 & group 2 continue to support CAR-M mechanism of action, demonstrating a correlation between biomarkers and best overall response

Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, will present findings today at the 8^th Annual CAR-TCR Summit from its Phase 1 clinical trial of the Company's lead product candidate, CT-0508, a human epidermal growth factor receptor 2 ("HER2") targeted chimeric antigen receptor macrophage ("CAR-M") for the treatment of advanced/metastatic HER2 overexpressing cancers.

The presentation includes data from group 1 (n=9) and group 2 (n=5). Patients in both groups received the same total dose (up to 5x10⁹ CT-0508) either via a fractionated, multi-day infusion regimen (group 1) or via a single-day bolus infusion (group 2). The data are drawn from the ongoing clinical trial led by Kim A. Reiss, MD, principal investigator of the Phase 1 clinical trial and an associate professor of Hematology-Oncology in the Perelman School of Medicine at the University of Pennsylvania.

In the presentation, Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma, will present data demonstrating that, in both groups, CT-0508 was successfully manufactured for patients and that the administration of CT-0508 was well-tolerated after infusion with no dose-limiting toxicities reported to date.

"As the CT-0508 trial progresses, it is promising to see consistent results supporting the safety profile, feasibility, and mechanism of action of this first-in-class CAR-M investigational therapy," commented Dr. Klichinsky. "We look forward to results from the CT-0508 combination sub-study with pembrolizumab and continued development of CAR-M and CAR-Monocyte therapies."

Previously, Carisma presented findings from group 1 showing that CT-0508 remodeled and activated the tumor microenvironment ("TME") and initiated anti-tumor T cell immunity. Translational analyses combining group 1 and group 2 show that various biomarkers including metrics of TME activation, T cell activation, and HER2 status correlate with best overall response ("BOR") of stable disease, providing further evidence of the CT-0508 mechanism of action.

https://www.biospace.com/article/releases/carisma-announces-latest-data-from-phase-1-clinical-trial-of-ct-0508-at-8th-annual-car-tcr-summit/