Polish Stem Cell Bank (PBKM) gets approval gene therapy medicinal product

So far, the availability of this life-saving therapy has been very limited due to the treatment costs reaching PLN 1.5 million.

The Polish Stem Cell Bank (PBKM) obtained the consent of the Chief Pharmaceutical Inspector (GIF) for the production of a gene therapy medicinal product, which is used in the treatment of cancers such as B-cell leukemia and B-cell lymphoma. This product is called FCTX-CL-19-1 and belongs to the CAR-T (chimeric antigen receptor) class of drugs.

The consent to manufacture the FCTX-CL-19-1 product was preceded by a technology transfer carried out for several months, which PBKM and its subsidiary FamiCordTx acquired from iCell Gene Therapeutics from the USA.

Thanks to the obtained consent, the product will be available to patients in a so-called “hospital exemption”, which is likely to begin in the coming months.

” We hope that thanks to us, CAR-T products will become much more available and that it will be possible to save more Polish patients. I do not hide that we also count on the openness of various clinical centers and public institutions to cooperation, ”said Tomasz Baran, president of FamiCordTx, quoted in the release.

The availability of the drug in the hospital exception procedure is the first stage of the project to obtain central registration for FCTX-CL-19-1 in the European Union, planned for several years. To do this, FamiCordTx will start clinical trials in 2021. Manufacturing will be based on the principles of contract manufacturing at PBKM. The process will be carried out with the support of external advisory entities in the field of registration and monitoring of clinical trials.

Polski Bank Komórek Macierzystych was founded in 2002 and deals with the acquisition, processing and long-term storage of stem cells derived from umbilical cord blood and other post-fetal tissues. The aim of PBKM’s activity is to provide a child or family members with quick access to biological material that can be used in modern therapies. The company made its debut on the WSE in 2016.


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