TiGenix’ eASC platform is based on expanded stem cells extracted from adipose tissue (eASCs), which are sourced from and applied to consenting patients. In contrast to cells of embryonic origin, there are no complex ethical issues associated with the use of ASCs. By using ASCs, TiGenix is able to capitalize on the benefits associated with this type of cell:
- Ease and amount of supply. The cells can be collected through standard liposuction.
- Rich supply of stem cells. Stem cells can represent up to 2% of the total cells of the stromal vascular fraction of the fat tissue, a potential yield of 100 to 1,000 times higher than other possible sources of stem cells.
- Robust phenotype. The eASCs do not require overly elaborate growth conditions and can be grown continuously without loss of their immunomodulatory characteristics. They have also been shown to maintain cell stability during expansion.
- Pharmacological profile. The eASCs have low immunogenicity as defined by the low presence or absence of human leukocyte antigens, co-stimulatory molecules and ligands for neurokinin receptors and are therefore considered to be applicable for allogeneic treatment.
MECHANISM OF ACTION (MoA)
There are two main biological pathways that underlie the efficacy of adipose-derived stem cells in disease treatment: their anti-inflammatory properties and their secretion of repair and growth promoting molecules. In particular, the immunomodulatory properties of these cells offer potential novel treatments for autoimmune and inflammatory diseases. The eASCs exhibit broad immunomodulatory properties, including the regulation of immune cells such as B lymphocytes, T lymphocytes, natural killer cells, monocytes or macrophages and neutrophils. These modulatory effects rely on a direct interaction between eASCs and immune cells as well as on the effect of substances secreted by the eASCs on tissues and cells through a broad panel of soluble factors. In particular the degradation of the amino acid tryptophan by the enzyme indoleamine 2,3 dioxygenase, is of key importance.
Our eASC-based product candidates (except Cx601 for the US) are manufactured at our facility in Madrid which has been approved by the Spanish Medicines and Medical Devices Agency as being compliant with current Good Manufacturing Practices (cGMP). We have successfully obtained a manufacturing license from the Spanish Medicines and Medical Devices Agency for the commercial production of Cx601.
Through our expansion process, we can generate up to 2,400 doses of Cx601 from cells extracted from a single healthy donor. We expect to continue producing Cx601 at our facility until Takeda assumes responsibility for manufacturing in Europe.
In the US, we have an agreement with Lonza, who will serve as contract manufacturing partner for the supply of cells required in our US trial.
As of 31st December 2016, we own or co-own 29 patent families and have more than 100 granted patents in more than 20 jurisdictions, including the United States, with expiration dates from 2020 onwards. Of these patents, 20 are related to our eASC-based technology platform, with expiration dates from 2024 onwards.
A number of our patent families are the result of collaborations with academic parties, and are jointly owned. Some of our important IP partners include: UAM, CSIC and Universidad de Sevilla.
We exclusively own the patents and patent applications that form the remainder of our patent portfolio.
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