Genetically engineered bacteria to drive wound healing
Ilya Pharma is looking for healthy volunteers 25-45 years old to participate in their first in human trial for use of genetically modified lactic acid bacteria to promote wound healing. The companies lead candidate ILP100 has been approved by the Swedish Medical Products Agency and will be trialled in ’Study 183’ – please see Brochure Attached.
ILP100 is based on genetically engineered lactic acid bacteria that express the human chemokine CXCL12, known to be involved in tissue regeneration. Ilya Pharma is utilising the genetically modified bacteria as mini bioreactors added topically to the wound site, providing fresh continuous administration of the short half-life protein. The mechanism of action (Vågesjö et al., 2018, PNAS) involves increasing the levels of CXCL12 in the wound so that “the body thinks that wound is much larger than it really is”. This results in more and more specified immune cells being recruited to the wound, and through e.g. secretion of TGFb, healing being accelerated.
“We are delighted that the MPA has approved our trial design since there is nothing “standard” about either our project, the IMP, or this first trial,” says Evelina Vågesjö, Ilya Pharma’s CEO. “This is one of the first clinical trials to be conducted with genetically engineered bacteria as a biologic and the first to be started with a topical IMP of this kind. Compared to the majority of other next-generation biologics e.g. cell- or gene therapy IMPs, ILP100 is a scalable product with excellent stability and very low manufacturing costs”.
The First in Human/Phase I trial contain two parts, a single ascending dose part and a multi ascending dose part with in total 36 healthy volunteers to be included. The study will be conducted in Uppsala, Sweden at the Phase I unit at Uppsala University Hospital.
Ilya Pharma is a clinical stage biopharma, developing novel drug candidates from its propriety technology platform to clinical proof of concept in relevant patient groups with identified unmet medical needs. www.ilyapharma.se