TK is an innovative cell therapy that aims to boost the survival of leukaemia patients undergoing stem cell transplantation with partially incompatible family donors, known as haplo-identical Haematopoietic Stem Cell Transplantation (haplo-HSCT). It involves the use of genetically engineered donor T lymphocytes in association with haplo-HSCT, in order to overcome serious complications arising from the transplant, while fully maintaining its immune-protective and anti-leukaemia effects. The most important complication of haplo-transplants is Graft versus Host Disease (GvHD), a systemic immune reaction mediated by donor T lymphocytes against the recipient's tissues. With MolMed's TK therapy, genetically modified donor T cells are made sensitive to the antiviral drug ganciclovir, and can be selectively eliminated through the administration of the drug if GvHD occurs.


Posters on results of clinical trials:


- ASCO 2010 - Long-term follow-up data of completed Phase II trial TK007 (ASCO poster #6534)

 

A pivotal Phase III trial (TK008) is ongoing in Europe and will involve 15 centres in different European countries, in Israel and in the US.  (US FDA clearance of IND in January 2011)

 

TK was granted Orphan Drug designation both in the EU (2003) and in the US (2005).

 

MolMed’s strategic partner Takara Bio Inc. (Japan) is developing TK for the Asian markets.