Developing immunotherapies using microorganisms delivering stable therapeutic proteins
to skin and mucosa
Developing immunotherapies using microorganisms delivering stable therapeutic proteins
to skin and mucosa
Therapeutic concepts, work and science being recognised for significant contributions in the advanced therapy pipeline in the MedicineMakers PowerList 2021.
The team also published an expert opinion on the mechanism of actions explored and progress of pipeline in 2019 in Öhnstedt et al., Expert Opinion on Drug Discovery 2019;14(5):485-497.
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.
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. The mechanism of action for CXCL12 and bacterial-delivered CXCL12 in accelerated restoration of tissue function were published in PNAS 2018 and Circulation Research 2021.
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.
