Enabling the full potential of local immunotherapies
Enabling the full potential of local immunotherapies
Cell and gene therapies are taking off in a big way in Europe. As the buzz grows, the Swedish firm Ilya Pharma has raised €8.5M to lay down the foundations of bacterial gene therapies for enterocolitis and diabetic ulcers.
Ilya Pharma, being a clinical stage biopharmaceutical development company is currently pursuing three projects with drug candidates from its proprietary ILP-technology platform to clinical proof of concept and validation.
The research is inspired by the early work of Professor Ilya Mechnicov who also received the Nobel Prize in 1908, read more here.
Well known, but biochemically instable, human therapeutic proteins are produced at the actual affected by live lactic acid bacteria acting as local mini-bioreactors. This provides a new and cost-effective way to deliver therapeutic proteins and enables development of a wide range of immunomodulatory proteins that are not suited to be developed as biologics.
The drug candidates are classified as ATMP and gene therapies by the EMA and FDA.
The innovation stems from cutting edge medical research in immunophysiology and applied microbiology at Uppsala University and the Swedish University of Agricultural Sciences. The treatments target the function of tissue-resident immune cells in different organs.
Unmet clinical needs targeted are treatment of injuries in skin and mucosal surfaces.
For the lead candidate ILP100 in a topical formulation, a first-in-human clinical trial (WHILYAS1, EudraCT No. 2019000680-24) have been successfully completed Q4 2020. With this milestone the Company have significantly de-risked the projects in regulatory, CMC and clinical for ILP-drug candidates.
The clinical phase II program have been outlined in pre-submissionmeetings with FDA and national regulators in Europe. A phase IIa study (WHILYAS2) in patients with diabetes and chronic wounds, funded by the EIC Accelerator is approved ans first dosing is expected in 2021.
For wound healing, the objectives are to deliver clinical value by providing cost efficient biological treatments substantially cheaper than traditional biologicals and with better efficacy than medical devices.
For treatment of immune mediated and treatment mediated enterophaties, especially colitis the, majority of patients are not responding to treatment with the available biologics. The company are currently performing IND-enabling studies and expect to be able to enter clinical testing in 18 months.
Ilya Pharma is today financed by a mix of grants and private funding. The company received a H2020 SME Instrument phase II grant 2018 of 3 MEUR and EIC Accelerator 2020 of 5.3 MEUR. The company is currently raising for the continued clinical development in phase IIs and IND enabling studies in IBD from suitable investors and potential partners with proven track record in cell- and gene therapy and therapeutics.
