Vita 34 AG has started enrollment in Phase I of the Tarcidomgen Kimleucel clinical trial. The drug candidate is an anti-CD19 CAR-T, a chimeric antigen receptor, and the first candidate in Vita 34's Cell & Gene Therapy (CGT) portfolio. After recent clearance by the responsible authorities and the responsible ethics committee, the start of the clinical trial under the name CARLA and the recruitment of the first patient ("First Patient In") 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 centers in Poland. The Management Board of Vita 34 AG expects Phase I to be completed by the end of 2023.

The costs related with this phase of the trial have already taken into consideration in the guidance published for 2023. The principal investigator of the CARLA study is Prof. Grzegorz Basak, Professor and Chairman of the Department of Hematology, Transplantation and Internal Medicine at the University Hospital of Warsaw Medical University. Tarcidomgen Kimlucel is being developed through FamiCordTx, a subsidiary of Vita 34 AG that aims to develop proprietary CAR-T drug therapies.

FamiCordTx has secured an exclusive license from a U.S. supplier for this purpose in the past and has optimized the technology according to European GMP standards. CAR-T therapy uses a patient's own T cells, which are genetically engineered in a laboratory to produce a protein called a chimeric antigen receptor (CAR). When the modified T-cells are returned to the patient, the CAR enables the T- cells to seek out and destroy cancer cells wherever they are in the body.

According to a report by Allied Market Research, the global CAR-T cell therapy market was valued USD 1,7 billion in 2021 and is expected to reach USD 6.1 billion by 2031.