Chimeric Therapeutics Ltd (ASX:CHM) has achieved a key development milestone by completing the manufacturing and quality release for the CHM 1101 (CLTX CAR T) viral vector.
The clinical-stage cell therapy company’s viral vector was developed and manufactured at City of Hope, a world-renowned cancer research and treatment organisation near Los Angeles.
Chimeric aims to expand the CHM 1101 (CLTX CAR T) clinical program with new clinical sites for the Phase 1 glioblastoma trial as well as a new Phase 1 clinical basket trial in solid tumours.
Coordinated expansion of Chimeric’s current technical operations is required to broaden its clinical development program.
The importance of viral vector
A challenging and critical component of cell therapy technical operations is the timely manufacturing and release of the viral vector, considered the backbone for the manufacture of a CAR T cell therapy as it holds the genetic engineering instructions.
A current shortage of vector-manufacturing capacity has significantly delayed other cell therapy company development programs, as well as challenging commercial manufacturers. Given these difficulties this is a critical milestone for Chimeric in supporting the broader Phase 1 clinical program expansion of CHM 1101 (CLTX CAR T).
“This marks a major milestone for advancing the development of CHM 1101,” said Chimeric CEO and managing director Jennifer Chow. “Vector supply significantly challenges the cell therapy industry with current backlogs of more than a year to access vector manufacturing. Securing vector for the expansion of our CHM 1101 development program enables us to move forward and is a clear demonstration of the benefit of our experienced cell therapy development team.”
What is Cart T
CHM 1101 (CLTX CAR T) is a novel CAR T therapy developed for the treatment of patients with solid tumours. CHM 1101 is currently being studied in a Phase 1 clinical trial in recurrent/progressive glioblastoma. Initial positive data has been presented on patients treated in the first two dose levels of the trial. A second CLTX CAR T Phase 1 clinical trial is planned to begin in metastatic melanoma with future expansion to additional solid tumours.