Chimeric Therapeutics Ltd (ASX:CHM) has successfully completed manufacturing for CHM 2101 research-grade plasmids, a critical first step in the development of CDH17 CAR T (Chimeric Antigen Receptor T-cell).
CHM 2101 is a novel, 3rd generation CDH17 CAR T invented at the University of Pennsylvania.
CHM 2101 (CDH17 CAR T) is currently in preclinical development with a planned phase 1 clinical trial in 2022 in neuroendocrine tumours, colorectal, pancreatic and gastric cancer.
First step in CAR T manufacturing
Manufacturing of CAR T therapies is dependent upon plasmids and viral vectors that hold the genetic instructions for each specific CAR T product.
Plasmids are small DNA molecules that carry genetic instructions and their successful manufacture marks an important early step for all CAR T therapies.
In collaboration with the University of Pennsylvania, all of the research-grade helper and transfer plasmids for the CDH17 CAR T have been completed and released.
The achievement of this first step in CAR T manufacturing enables progression to research vector manufacturing, GMP plasmid and vector manufacturing and advancement of technical operations in readiness for the CDH17 CAR T phase 1 clinical trial.
Moving CAR T forward to phase 1 clinical trials
Chimeric CEO and managing director Jennifer Chow said: “We are very pleased that we have been able to achieve this key first step so rapidly after licensing.
“This accomplishment speaks to the commitment and drive that the Chimeric and University of Pennsylvania teams share to move this important CAR T forward to phase 1 clinical trials.”
In addition to commencing the CDH17 CAR T phase 1 trial in 2022, Chimeric is also progressing its CLTX CAR T phase 1 clinical trial in glioblastoma (brain cancer) at The City of Hope Cancer Centre in California, where patients are now receiving second dose levels.