Vita 34 Starts Recruitment for Clinical Trial with CAR-T Drug Candidate

• Approval by responsible authorities and ethics committee granted
• Recruitment of the first patient imminent
• Completion of Phase I expected by the end of 2023

Leipzig, 12 May 2023 - Vita 34 AG (ISIN: DE000A0BL849; WKN: A0BL84), the leading cell bank in Europe and the third largest worldwide, 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. "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 hematology and oncology. We are currently beginning to enroll patients to receive this drug therapy."

Tarcidomgen Kimleucel 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.  "After reaching production readiness within the Vita34 group 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. 

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. The increasing prevalence of cancer and the rising demand for personalized medicine are the major factors driving the growth of the CAR-T cell therapy market. "CAR-Ts are a relatively new category of drugs that are gaining medical visibility and market importance. One of the obstacles is the relative cost of the therapy. A single therapy currently costs around EUR 300,000, so their access is somehow limited. Our goal is to make the therapy significantly more affordable and thus more accessible," commented Anna Jakubowski, CEO 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."

Contact:
Ingo Middelmenne
Investor Relations
Vita 34 AG
Phone: +49 (0341) 48792 - 0
Mobile: +49 (0174) 9091190
Email: ingo.middelmenne@vita34.de

About Vita 34

Vita 34 was founded in Leipzig in 1997 and is today by far the leading cell bank in Europe and the third largest worldwide. As Europe's first private cord blood bank and a pioneer in cell banking, the company has since offered collection logistics, processing and storage of stem cells from umbilical cord blood, umbilical cord tissue and other postnatal tissues as a full-service cryopreservation provider. Based on the expansion of the business model that took place after the merger with PBKM, the company intends to invest in the areas of Cell and Gene therapies and CDMO. The body's own cells are a valuable starting material for medical cell therapy and are kept alive in the vapors of liquid nitrogen. Customers from around 50 countries have already ensured the health of their families with more than 930,000 units of stored biological material at Vita 34.