FamiCordTx launches first in human application of CAR-T drug candidates

FamiCord Group, a leading cell bank in Europe and one of the largest globally, has begun enrollment in Phase I of the Tarcidomgen Kimleucel clinical trial – through is majority owned company FamiCordTx. This promising drug candidate is an anti-CD19 CAR-T, a chimeric antigen receptor, and marks the first candidate in FamiCord Group’s growing Cell & Gene Therapy (CGT) portfolio.

After recent clearance by the responsible authorities and the ethics committee clereance, the start of the clinical trial under the name CARLA and the recruitment of the first patient is imminent. A total of up to ten patients are expected to be recruited for Phase I of the study, which is the usual number for this type of drug. The recruitment will take place via two clinical centres in Poland.

The principal investigator of the CARLA study is Prof. Grzegorz Basak, Professor and Chairman of the Department of Haematology, Transplantation and Internal Medicine at the University Hospital of Warsaw Medical University. “We are pleased to collaborate with FamiCordTx on this project,” says Prof. G. Basak. “CAR-T therapy is one of the most promising therapies in haematology and oncology. We are currently beginning to enroll patients to receive this drug therapy.”

Tarcidomgen Kimleucel is being developed through FamiCordTx, a subsidiary of FamiCord that aims to develop proprietary CAR-T drug therapies. “After reaching production readiness in 2022, we have submitted the protocol for the first phase clinical trial under the name CARLA, which will target patients with various B-cell malignancies,” explains T. Kolanowski, PhD, Chief Scientific Officer of FamiCordTx.

“We are very excited to enter the CAR-T market, which has immense potential to revolutionize cancer treatment. Our CAR-T drug candidate has shown promising results in preclinical studies,” said Jakub Baran, CEO of Vita 34 AG, summarizing the market potential of CAR-T cell therapy. “We are looking forward to the results of the CARLA study and the efficacy of Tarcidomgen Kimleucel in the further phases of the study. We are convinced that with our expertise in cell and gene therapies in combination with our production capacities we can make an important contribution in this field.”